Oracle® Health Sciences Clinical Development Analytics

User's Guide

Release 3.2.1

E86400-01

April 2017

Oracle Health Sciences Clinical Development Analytics User's Guide, Release 3.2.1

E86400-01

Copyright © 2010, 2017, Oracle and/or its affiliates. All rights reserved.

This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited.

The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing.

If this is software or related documentation that is delivered to the U.S. Government or anyone licensing it on behalf of the U.S. Government, then the following notice is applicable:

U.S. GOVERNMENT END USERS: Oracle programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, delivered to U.S. Government end users are "commercial computer software" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, use, duplication, disclosure, modification, and adaptation of the programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, shall be subject to license terms and license restrictions applicable to the programs. No other rights are granted to the U.S. Government.

This software or hardware is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications that may create a risk of personal injury. If you use this software or hardware in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software or hardware in dangerous applications.

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registered trademark of The Open Group.

This software or hardware and documentation may provide access to or information about content, products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content, products, and services unless otherwise set forth in an applicable agreement between you and Oracle. Oracle Corporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of third-party content, products, or services, except as set forth in an applicable agreement between you and Oracle.

Contents

List of Figures

List of Tables

Preface

- Audience

- Documentation Accessibility

- Finding Information and Patches on My Oracle Support

- Finding Documentation on Oracle Technology Network

- Related Documents

- Conventions

Part I Using Oracle Health Sciences Clinical Development Analytics

1 Getting Started with Oracle Health Sciences Clinical Development Analytics

- Overview

- What Can I Do Using Oracle Health Sciences Clinical Development Analytics?

- Architecture

- Reporting

- Regulatory Compliance

- Tracking Data

- Managing ETL Versions

- Security

2 Using Oracle Health Sciences Clinical Development Analytics

- Overview

- Accessing Oracle Health Sciences Clinical Development Analytics

- Logging In

- Viewing a Dashboard

- Using Oracle Business Intelligence

- Oracle Business Intelligence Presentation Services Components

- Oracle Business Intelligence Catalog

- Oracle Business Intelligence Analysis Editor

- Oracle Business Intelligence Interactive Home Page

- Oracle Business Intelligence Interactive Dashboards

- Oracle Business Intelligence Delivers

- Performing Common Tasks in Oracle Business Intelligence

- Exiting from Oracle Business Intelligence

- Using Online Help

- Printing an Oracle BI Dashboard or Saved Analysis

- Emailing an Oracle BI Dashboard Page or Analysis

- Exporting Oracle BI Results

- Refreshing an Oracle BI Interactive Dashboard or Oracle BI Analysis

- Refreshing Information in the Oracle BI Selection Pane

- Navigating in Oracle Business Intelligence

- What is Available to You After Accessing Oracle BI?

- Using Oracle BI Global Header

- Drilling Down in Oracle BI

- Sorting Columns in Tables in Oracle BI

- Using the Oracle BI My Account Page

- Setting Your Oracle BI Preferences

- Setting Your Oracle BI Time Zone

3 Working with Analyses

- Predefined Analyses

- Viewing a Predefined Analysis

- Custom Analyses

- Action Links

- Viewing Analyses With Your Apple iPhone and iPad

- Catalog Page

- Dashboard Page

- Indicators

- Study Indicators

- Study KPI Flag

- Study Milestones Flag

- Study Recruitment Flag

- Study Retention Flag

- Study-Region Indicators

- Study-Region Milestones Flag

- Study-Region Recruitment Flag

- Study-Region Retention Flag

- Study-Site Indicators

- Study-Site Milestones Flag

- Study-Site Recruitment Flag

- Study-Site Retention Flag

Part II Appendixes

A Dashboards and Analyses

- Oracle Health Sciences Clinical Development Analytics Dashboards

- CRA Dashboard

- CRA Dashboard Pages

- Data Manager - EDC Dashboard

- Data Manager - EDC Dashboard Pages

- Data Manager - Paper Dashboard

- Data Manager - Paper Dashboard Pages

- Executive Dashboard

- Executive Dashboard Pages

- Region Manager Dashboard

- Region Manager Dashboard Pages

- Study Manager Dashboard

- Study Manager Dashboard Pages

- Study Overview Dashboard

- Study Overview Dashboard Pages

- Study-Region Overview Dashboard

- Study-Region Overview Dashboard Pages

- Study-Site Overview Dashboard

- Study-Site Overview Dashboard Pages

- Index Dashboard

- Index Dashboard Pages

- Oracle Health Sciences Clinical Development Analytics Analyses

- # Follow Up Items by Type (Multiple Study-Sites) (Report CDA-CO-810)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- # Follow Up Items by Type for Study-Site (Report CDA-CO-801)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Approval & Verification Rates - Worst Performers (Report CDA-DM-350)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-825)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Average Days from Complete to Initially Approved (Report CDA-DM-325)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Average Days from Complete to Initially Verified (Report CDA-DM-330)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Average Days Discrepancy (Query) Open (Report CDA-DM-205)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-823)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Data Quality Study Risk Gauges (Report CDA-DM-500)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Data Quality Study-Site Risk Gauges (Report CDA-DM-505)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Detail Study-Site Map (Report CDA-CO-1201)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Detailed Study Milestones Report (Report CDA-CO-102)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Documents List (Multiple Study-Sites) (Report CDA-CO-601)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Documents List (Study Region) (Report CDA-CO-610)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Documents List (Study-Site) (Report CDA-CO-603)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Enrollment Overview By Site (Report CDA-CO-426)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Essential Documents Study Risk Gauges (Report CDA-CO-620)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Essential Documents Study-Site Risk Gauges (Report CDA-CO-625)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Executive Study-Site Map (Report CDA-CO-1203)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- High Level Study-Site Map (Report CDA-CO-1202)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Investigator Contact and Studies List (Report CDA-CO-202)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Issue Management Study Risk Gauges (Report CDA-CO-840)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Issue Management Study-Site Risk Gauges (Report CDA-CO-845)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Key Cycle Times for Paper Studies (Report CDA-DM-400)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Key EDC Cycle Times (Report CDA-DM-300)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Key EDC Processing Volumes (Report CDA-DM-305)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Key Paper Processing Volumes (Report CDA-DM-405)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Key Performance Indicators Over Time - Monitoring (Region Manager) (Report CDA-CO-1112)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - LSLV to Database Lock (Executive View) (Report CDA-CO-906)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- KPI Summary - Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- List Discrepancy (Query) Details (Report CDA-DM-245)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- List of Follow Up Items (Report CDA-CO-803)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Median # Follow Up Items per Site for Study (Report CDA-CO-802)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Monitoring Report Approval - Turnaround Time vs. Goal (Report CDA-CO-813)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Number of Studies (Report CDA-CO-1001)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-826)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-828)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Documents List (Report CDA-CO-602)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Follow up Items - Study Overview (Report CDA-CO-805)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Follow up Items (CRA View) (Report CDA-CO-806)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Monitoring Report Approvals (Study-Region) (Report CDA-CO-831)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Monitoring Reports (Study-Region View) (Report CDA-CO-830)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed (Report CDA-CO-824)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Outstanding Reports that Missed Target - Site Visit Completed to Visit Report Completed (Report CDA-CO-827)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Pages Awaiting Entry Completion (Report CDA-DM-450)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Paper Processing - Longest Cycle Times (Report CDA-DM-415)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Protocol Deviations (Study-Site) by Category (Report CDA-CO-1301)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Protocol Deviations (Subject) by Category (Report CDA-CO-1302)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Protocol Deviations (Study-Site) Tile (Report CDA-CO-1303)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Protocol Deviations (Subject) Tile (Report CDA-CO-1304)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Protocol Deviations Overview by Study-Site (Report CDA-CO-1305)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Protocol Deviation (Subject) Details (Report CDA-CO-1307)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Protocol Versions (Report CDA-CO-115)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Screen Failure Reason (Report CDA-CO-420)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Screen Failure Reason (Report CDA-CO-425)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Screen Failure Reason by Site (Report CDA-CO-300)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Screening Overview (Study Level) (Report CDA-CO-407)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Screening Overview (Study-Region Level) (Report CDA-CO-434)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Screening Overview (Study-Site Level) (Report CDA-CO-415)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Screening vs. Enrollment by Region (Report CDA-CO-400)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Detail (Report CDA-CO-209)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Recruitment Performance - Single Study (Report CDA-CO-416)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Recruitment Performance (Report CDA-CO-413)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Visit Analysis (Report CDA-CO-821)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Visit Duration - Study (Report CDA-CO-808)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Visit Duration - Study Site (Report CDA-CO-800)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Site Visit Duration - Study-Region (Report CDA-CO-829)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Documents List (Report CDA-CO-600)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Enrollment Progress Gauge (Report CDA-CO-445)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study Information (Report CDA-CO-103)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study List - Initiation Details (Report CDA-CO-305)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study List - KPI Performance (Report CDA-CO-904)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study List - Milestone Performance (Report CDA-CO-109)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study List - Recruitment Details (Report CDA-CO-406)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study RACT (Report CDA-CO-852)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study RACT by Category (Report CDA-CO-853)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study RACT Score Tile (Report CDA-CO-858)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators (Single Study-Region) - Data Management View (Report CDA-CO-1116A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View (Report CDA-CO-1116B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View (Report CDA-CO-1116C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View (Report CDA-CO-1116D)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View (Report CDA-CO-1116E)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Regions with Red or Yellow Performance Flag - Data Management Detail View (Report CDA-CO-1200A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study Team Member List (Report CDA-CO-111)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Region Information (Report CDA-CO-1113)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Region List - Recruitment Details (Report CDA-CO-433)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Region List and Recruitment Counts (Report CDA-CO-404)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Region Team Member List (Report CDA-CO-1107)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Enrollment Progress Gauge (Report CDA-CO-455)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study-Site Information (Report CDA-CO-206)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site List with Indicators - Data Management View (Report CDA-CO-207A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site List with Indicators - Monitoring View (Report CDA-CO-207B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site List with Indicators - Recruitment Detail View (Report CDA-CO-207C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site List with Indicators - Retention Detail View (Report CDA-CO-207D)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site List with Indicators - Site Start Up Detail View (Report CDA-CO-207E)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site List with Indicators - Study Close Detail View (Report CDA-CO-207F)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site List with Indicators - Summary View (Report CDA-CO-207G)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (Single Study-Site) - Data Management View (Report CDA-CO-203A)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View (Report CDA-CO-203C)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View (Report CDA-CO-203D)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View (Report CDA-CO-203E)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View (Report CDA-CO-203F)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Missed Dose Details (Report CDA-CO-215)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study-Site Missed Dose Tile (Report CDA-CO-220)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study-Site RACT (Report CDA-CO-856)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study-Site RACT by Category (Report CDA-CO-857)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study-Site RACT Score Tile (Report CDA-CO-859)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study-Site Risk Indicator Map (Report CDA-CO-1210)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Study-Site Subject Recruitment Narrative (Report CDA-CO-405)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Subject Retention (Report CDA-CO-500)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Site Team Member List (Report CDA-CO-201)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Enrollment by Region (Report CDA-CO-414)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Recruitment and Discontinuation Study Risk Gauges (Report CDA-CO-440)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Subject Recruitment and Discontinuation Study-Site Risk Gauges (Report CDA-CO-450)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Subject Recruitment (Report CDA-CO-419)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Recruitment (Study Region) (Report CDA-CO-1114)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Retention (Report CDA-CO-504)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Retention (Study Level) (Report CDA-CO-503)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Retention (Study Region) (Report CDA-CO-1115)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Retention (Study-Site Level) (Report CDA-CO-502)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Retention Over Time (Study Level) (Report CDA-CO-501)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Retention Over Time (Study-Site Level) (Report CDA-CO-510)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subjects Enrolled per Month, Over Time (Report CDA-CO-403)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subjects who Failed Screening (Report CDA-CO-428)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Subjects Withdrawn List (Report CDA-CO-509)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Top Investigators, Total Enrollment (Report CDA-CO-701)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Total Subject Enrollment by Region (Report CDA-CO-410)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Uninitiated Sites (Report CDA-CO-304)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Withdrawn Reason (Report CDA-CO-505)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

- Withdrawn Reason Overview (Report CDA-CO-508)

- Audience

- Report Type

- Location

- Dimensions

- Supplementary Prompts

- Reports Referenced

- Reports Referencing This Report

- Column Descriptions

B Oracle Health Sciences Clinical Development Analytics Presentation Catalog

- Dimensions in OHSCDA Presentation Catalog

- Facts in OHSCDA Presentation Catalog

- Oracle Clinical Sources for OHSCDA Presentation Catalog

- Oracle Clinical Sources

- Aliases

- Oracle's Siebel Clinical Sources for OHSCDA Presentation Catalog

- Oracle Health Sciences InForm Sources for OHSCDA Presentation Catalog

Glossary

Index

List of Figures

- 1-1 Oracle Health Sciences Clinical Development Analytics Architecture

- 2-1 The Analysis Hierarchy

List of Tables

- 2-1 Accessing Online Help

- 2-2 Oracle BI Global Header

- 3-1 Components of Catalog Page

- A-1 # Follow Up Items by Type (multiple Study-Sites) (Report CDA-CO-810)

- A-2 # Follow Up Items by Type for Study-Site (Report CDA-CO-801)

- A-3 Approval and Verification Rates - Worst Performers (Report CDA-DM-350)

- A-4 Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-825)

- A-5 Average Days from Complete to Initially Approved - Top N (Report CDA-DM-325)

- A-6 Average Days from Complete to Initially Verified - Top (Report CDA-DM-330)

- A-7 Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

- A-8 Average Days Discrepancy (Query) Open (Report CDA-DM-205)

- A-9 Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

- A-10 Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-823)

- A-11 Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

- A-12 Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

- A-13 Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

- A-14 Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

- A-15 Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

- A-16 Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

- A-17 Detail Study-Site Map (Report CDA-CO-1201)

- A-18 Detailed Study Milestones Report (Report CDA-CO-102)

- A-19 Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

- A-20 Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

- A-21 Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

- A-22 Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

- A-23 Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

- A-24 Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

- A-25 Documents List (Multiple Study-Sites) (Report CDA-CO-601)

- A-26 Documents List (Study Region) (Report CDA-CO-610)

- A-27 Documents List (Study-Site) (Report CDA-CO-603)

- A-28 Enrollment Overview By Site (Report CDA-CO-426)

- A-29 Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

- A-30 Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)

- A-31 Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)

- A-32 Executive Study-Site Map (Report CDA-CO-1203)

- A-33 High Level Study-Site Map (Report CDA-CO-1202)

- A-34 Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

- A-35 Investigator Contact and Studies List (Report CDA-CO-202)

- A-36 Key Cycle Times for Paper Studies (Report CDA-DM-400)

- A-37 Key EDC Cycle Times (Report CDA-DM-300)

- A-38 Key EDC Processing Volumes (Report CDA-DM-305)

- A-39 Key Paper Processing Volumes (Report CDA-DM-405)

- A-40 Key Performance Indicators Over Time: Monitoring (Region Manager) (Report CDA-CO-1112)

- A-41 Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)

- A-42 KPI Summary: CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)

- A-43 KPI Summary: CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

- A-44 KPI Summary: LSLV to Database Lock (Executive View) (Report CDA-CO-906)

- A-45 KPI Summary: Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)

- A-46 KPI Summary: Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)

- A-47 KPI Summary: Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)

- A-48 KPI Summary: Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

- A-49 KPI Summary: Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

- A-50 KPI Summary: Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)

- A-51 List Discrepancy (Query) Details (Report CDA-DM-245)

- A-52 List of Follow Up Items (Report CDA-CO-803)

- A-53 Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

- A-54 Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

- A-55 Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)

- A-56 Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)

- A-57 Median # Follow Up Items per Site for Study (Report CDA-CO-802)

- A-58 Monitoring Report Approval - Turnaround Time vs. Goal (Report CDA-CO-813)

- A-59 Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

- A-60 Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

- A-61 Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

- A-62 Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

- A-63 Number of Studies (Report CDA-CO-1001)

- A-64 Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-826)

- A-65 Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-828)

- A-66 Outstanding Documents List (Report CDA-CO-602)

- A-67 Outstanding Follow up Items - Study Overview (Report CDA-CO-805)

- A-68 Outstanding Follow up Items (CRA View) (Report CDA-CO-806)

- A-69 Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

- A-70 Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)

- A-71 Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)

- A-72 Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)

- A-73 Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

- A-74 Outstanding Visit Report Approvals (Study-Region) (Report CDA-CO-831)

- A-75 Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)

- A-76 Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

- A-77 Outstanding Visit Reports (Study-Region View) (Report CDA-CO-830)

- A-78 Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)

- A-79 Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed (Report CDA-CO-824)

- A-80 Outstanding Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-827)

- A-81 Pages Awaiting Entry Completion (Report CDA-DM-450)

- A-82 Paper Processing - Longest Cycle Times (Report CDA-DM-415)

- A-83 Performance Metrics Summary Narrative: Site Visit (Report CDA-CO-1110)

- A-84 Screen Failure Reason (Report CDA-CO-420)

- A-85 Screen Failure Reason (Report CDA-CO-425)

- A-86 Screen Failure Reason by Site (Report CDA-CO-300)

- A-87 Screening Overview (Study Level) (Report CDA-CO-407)

- A-88 Screening Overview (Study-Region Level) (Report CDA-CO-434)

- A-89 Screening Overview (Study-Site Level) (Report CDA-CO-415)

- A-90 Screening vs. Enrollment by Region (Report CDA-CO-400)

- A-91 Site Detail (Report CDA-CO-209)

- A-92 Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)

- A-93 Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)

- A-94 Site Recruitment Performance - Single Study (Report CDA-CO-416)

- A-95 Site Recruitment Performance (Report CDA-CO-413)

- A-96 Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)

- A-97 Site Visit Analysis (Report CDA-CO-821)

- A-98 Site Visit Duration - Study (Report CDA-CO-808)

- A-99 Site Visit Duration - Study Site (Report CDA-CO-800)

- A-100 Site Visit Duration - Study-Region (Report CDA-CO-829)

- A-101 Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

- A-102 Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

- A-103 Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

- A-104 Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

- A-105 Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

- A-106 Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

- A-107 Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

- A-108 Study Documents List (Report CDA-CO-600)

- A-109 Study Information (Report CDA-CO-103)

- A-110 Study List - Initiation Details (Report CDA-CO-305)

- A-111 Study List: KPI Performance (Report CDA-CO-904)

- A-112 Study List: Milestone Performance (Report CDA-CO-109)

- A-113 Study List - Recruitment Details (Report CDA-CO-406)

- A-114 Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

- A-115 Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- A-116 Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)

- A-117 Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)

- A-118 Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)

- A-119 Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)

- A-120 Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)

- A-121 Study Region Milestones with Indicators (Single Study-Region) - Data Management View (Report CDA-CO-1116A)

- A-122 Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View (Report CDA-CO-1116B)

- A-123 Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View (Report CDA-CO-1116C)

- A-124 Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View (Report CDA-CO-1116D)

- A-125 Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View (Report CDA-CO-1116E)

- A-126 Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)

- A-127 Study Region vs. Study: Site Start Up KPIs (Report CDA-CO-1111)

- A-128 Study Regions with Red or Yellow Performance Flag - Data Management Detail View (Report CDA-CO-1200A)

- A-129 Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)

- A-130 Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)

- A-131 Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)

- A-132 Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)

- A-133 Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)

- A-134 Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)

- A-135 Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)

- A-136 Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)

- A-137 Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)

- A-138 Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)

- A-139 Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)

- A-140 Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)

- A-141 Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

- A-142 Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

- A-143 Study Team Member List (Report CDA-CO-111)

- A-144 Study-Region Information (Report CDA-CO-1113)

- A-145 Study-Region List - Initiation Details (Report CDA-CO-306)

- A-146 Study-Region List: KPI Performance (Report CDA-CO-1108)

- A-147 Study-Region List: Milestone Performance (Report CDA-CO-1109)

- A-148 Study-Region List - Recruitment Details (Report CDA-CO-433)

- A-149 Study-Region List and Recruitment Counts (Report CDA-CO-404)

- A-150 Study-Region Team Member List (Report CDA-CO-1107)

- A-151 Study-Site Information (Report CDA-CO-206)

- A-152 Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

- A-153 Study-Site List with Indicators - Data Management View (Report CDA-CO-207A)

- A-154 Study-Site List with Indicators - Monitoring View (Report CDA-CO-207B)

- A-155 Study-Site List with Indicators - Recruitment Detail View (Report CDA-CO-207C)

- A-156 Study-Site List with Indicators - Retention Detail View (Report CDA-CO-207D)

- A-157 Study-Site List with Indicators - Site Start Up Detail View (Report CDA-CO-207E)

- A-158 Study-Site List with Indicators - Study Close Detail View (Report CDA-CO-207F)

- A-159 Study-Site List with Indicators - Summary View (Report CDA-CO-207G)

- A-160 Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

- A-161 Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

- A-162 Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

- A-163 Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

- A-164 Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

- A-165 Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

- A-166 Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

- A-167 Study-Site Milestones with Indicators (Single Study-Site) - Data Management View (Report CDA-CO-203A)

- A-168 Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)

- A-169 Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View (Report CDA-CO-203C)

- A-170 Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View (Report CDA-CO-203D)

- A-171 Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View (Report CDA-CO-203E)

- A-172 Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View (Report CDA-CO-203F)

- A-173 Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)

- A-174 Study-Site Subject Recruitment Narrative (Report CDA-CO-405)

- A-175 Study-Site Subject Retention (Report CDA-CO-500)

- A-176 Study-Site Team Member List (Report CDA-CO-201)

- A-177 Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

- A-178 Subject Enrollment by Region (Report CDA-CO-414)

- A-179 Subject Recruitment (Report CDA-CO-419)

- A-180 Subject Recruitment (Study Region) (Report CDA-CO-1114)

- A-181 Subject Retention (Report CDA-CO-504)

- A-182 Subject Retention (Study Level) (Report CDA-CO-503)

- A-183 Subject Retention (Study Region) (Report CDA-CO-1115)

- A-184 Subject Retention (Study-Site Level) (Report CDA-CO-502)

- A-185 Subject Retention Over Time (Study Level) (Report CDA-CO-501)

- A-186 Subject Retention Over Time (Study-Site Level) (Report CDA-CO-510)

- A-187 Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

- A-188 Subjects Enrolled per Month, Over Time (Report CDA-CO-403)

- A-189 Subjects who Failed Screening (Report CDA-CO-428)

- A-190 Subjects Withdrawn List (Report CDA-CO-509)

- A-191 Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

- A-192 Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

- A-193 Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

- A-194 Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- A-195 Top Investigators, Total Enrollment (Report CDA-CO-701)

- A-196 Total Subject Enrollment by Region (Report CDA-CO-410)

- A-197 Uninitiated Sites (Report CDA-CO-304)

- A-198 Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

- A-199 Withdrawn Reason (Report CDA-CO-505)

- A-200 Withdrawn Reason Overview (Report CDA-CO-508)

- B-1 Presentation Catalog - Dimensions

- B-2 Presentation Catalog - Facts

- B-3 Presentation Catalog - Oracle Clinical Sources

- B-4 Aliases for Table Names

- B-5 Presentation Catalog - Siebel Clinical Sources

- B-6 Presentation Catalog - InForm Sources

Preface

This guide provides information about how to use Oracle Health Sciences Clinical Development Analytics (OHSCDA).

This preface contains the following topics:

- Audience

- Documentation Accessibility

- Finding Information and Patches on My Oracle Support

- Finding Documentation on Oracle Technology Network

- Related Documents

- Conventions

Audience

The first and second chapters of this guide are intended for the following job classifications:

- Clinical Program/Study Manager, Clinical Data Manager, Clinical Research Associate, Clinical Data Entry Manager, Site Personnel, and Executive Management.

The other chapters in this guide are intended for the following job classifications:

- Data Warehouse Administrators, ETL Developers and Operators

- System Administrator

This guide assumes that you have the following general skills:

- Knowledge of Oracle Business Intelligence Enterprise Edition Plus

- Knowledge of Oracle Healthcare Analytics Data Integration (ODI)

- Familiarity with Oracle Health Sciences InForm

- Familiarity with Oracle Clinical

- Familiarity with Oracle's Siebel Clinical

Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

Finding Information and Patches on My Oracle Support

Your source for the latest information about Oracle Health Sciences Clinical Development Analytics is Oracle Support's self-service Web site, My Oracle Support (formerly MetaLink).

Before you install and use an Oracle software release, always visit the My Oracle Support Web site for the latest information, including alerts, release notes, documentation, and patches.

Creating a My Oracle Support Account

You must register at My Oracle Support to obtain a user name and password account before you can enter the Web site.

To register for My Oracle Support:

1. Open a Web browser to http://support.oracle.com.

2. Click Register here to create a My Oracle Support account. The registration page opens.

3. Follow the instructions on the registration page.

Signing In to My Oracle Support

To sign in to My Oracle Support:

1. Open a Web browser to http://support.oracle.com.

2. Click Sign In.

3. Enter your user name and password.

4. Click Go to open the My Oracle Support home page.

Searching for Knowledge Articles by ID Number or Text String

The fastest way to search for product documentation, release notes, and white papers is by the article ID number.

To search by the article ID number:

1. Sign in to My Oracle Support at http://support.oracle.com.

2. Locate the Search box in the upper right corner of the My Oracle Support page.

3. Click the sources icon to the left of the search box, and then select Article ID from the list.

4. Enter the article ID number in the text box.

5. Click the magnifying glass icon to the right of the search box (or press the Enter key) to execute your search.
The Knowledge page displays the results of your search. If the article is found, click the link to view the abstract, text, attachments, and related products.

In addition to searching by article ID, you can use the following My Oracle Support tools to browse and search the knowledge base:

- Product Focus — On the Knowledge page, you can drill into a product area through the Browse Knowledge menu on the left side of the page. In the Browse any Product, By Name field, type in part of the product name, and then select the product from the list. Alternatively, you can click the arrow icon to view the complete list of Oracle products and then select your product. This option lets you focus your browsing and searching on a specific product or set of products.

- Refine Search — Once you have results from a search, use the Refine Search options on the right side of the Knowledge page to narrow your search and make the results more relevant.

- Advanced Search — You can specify one or more search criteria, such as source, exact phrase, and related product, to find knowledge articles and documentation.

Finding Patches on My Oracle Support

Be sure to check My Oracle Support for the latest patches, if any, for your product. You can search for patches by patch ID or number, or by product or family.

To locate and download a patch:

1. Sign in to My Oracle Support at http://support.oracle.com.

2. Click the Patches & Updates tab.
The Patches & Updates page opens and displays the Patch Search region. You have the following options:

- In the Patch ID or Number is field, enter the primary bug number of the patch you want. This option is useful if you already know the patch number.

- To find a patch by product name, release, and platform, click the Product or Family link to enter one or more search criteria.

3. Click Search to execute your query. The Patch Search Results page opens.

4. Click the patch ID number. The system displays details about the patch. In addition, you can view the Read Me file before downloading the patch.

5. Click Download. Follow the instructions on the screen to download, save, and install the patch files.

Finding Documentation on Oracle Technology Network

The Oracle Technology Network Web site contains links to all Oracle user and reference documentation. To find user documentation for Oracle products:

1. Go to the Oracle Technology Network at
http://www.oracle.com/technetwork/index.html and log in.

2. Mouse over the Support tab, then click the Documentation hyperlink.
Alternatively, go to Oracle Documentation page at

http://www.oracle.com/technology/documentation/index.html

3. Navigate to the product you need and click the link.
For example, scroll down to the Applications section and click Oracle Health Sciences Applications.

4. Click the link for the documentation you need.

Related Documents

For more information, see the following documents in the Oracle Healthcare Analytics Data Integration, Oracle Business Intelligence Enterprise Edition, Oracle Clinical, Siebel Clinical, Oracle Health Sciences InForm, and Oracle Data Integrator documentation sets:

Oracle Healthcare Analytics Data Integration Documentation

The Oracle Healthcare Analytics Data Integration documentation set includes:

- Oracle Healthcare Analytics Data Integration Secure Installation and Configuration Guide

Oracle Business Intelligence Enterprise Edition Documentation

The Oracle Business Intelligence Suite Enterprise Edition (OBIEE) documentation set includes:

- Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition

- Oracle Fusion Middleware Metadata Repository Builder's Guide for Oracle Business Intelligence Enterprise Edition

- Oracle Fusion Middleware System Administrator's Guide for Oracle Business Intelligence Enterprise Edition

- Oracle Fusion Middleware Scheduling Jobs Guide for Oracle Business Intelligence Enterprise Edition

- Oracle Fusion Middleware Security Guide for Oracle Business Intelligence Enterprise Edition

- Oracle Fusion Middleware Developer's Guide for Oracle Business Intelligence Enterprise Edition

- Oracle Fusion Middleware Integrator's Guide for Oracle Business Intelligence Enterprise Edition

Oracle Clinical Documentation

The Oracle Clinical documentation set includes:

- Oracle Clinical Administrator's Guide

- Oracle Clinical Getting Started

- Interfacing from Oracle Clinical

- Oracle Clinical Conducting a Study

- Oracle Clinical Creating a Study

- Oracle Clinical Installation Guide

Siebel Clinical Documentation

The Siebel Clinical documentation set includes:

- Siebel Data Model Reference for Industry Applications

- Siebel Life Sciences Guide

Oracle Health Sciences InForm Documentation

The Oracle Health Sciences InForm documentation set includes:

- Oracle Health Sciences InForm Upgrade and Migration Guide

- Oracle Health Sciences InForm Installation Guide

- Oracle Health Sciences InForm Study and Reporting Setup Guide

- Oracle Health Sciences InForm User Guide

- Oracle Health Sciences InForm Reporting and Analysis

- Oracle Health Sciences InForm Utilities Guide

- Oracle Health Sciences InForm Clinical Data API Guide

- Oracle Health Sciences InForm Reporting Database Schema

- Oracle Health Sciences InForm Secure Configuration Guide

- Oracle Health Sciences InForm Third Party Licenses and Notices

Oracle Data Integrator (ODI) Documentation

The Oracle Data Integrator documentation set includes:

- Release Notes for Oracle Data Integrator

- Understanding Oracle Data Integrator

- Administering Oracle Data Integrator

- Installing and Configuring Oracle Data Integrator

- Application Adapters Guide for Oracle Data Integrator

- Developing Knowledge Modules with Oracle Data Integrator

- Connectivity and Knowledge Modules Guide for Oracle Data Integrator

- Oracle Data Integrator Tool Reference

- Java API Reference for Oracle Data Integrator

- Oracle Data Integrator Online Help

Conventions

The following text conventions are used in this document:

Convention

Meaning

boldface

Boldface type indicates graphical user interface elements associated with an action, or terms defined in text or the glossary.

italic

Italic type indicates book titles, emphasis, or placeholder variables for which you supply particular values.

monospace

Monospace type indicates commands within a paragraph, URLs, code in examples, text that appears on the screen, or text that you enter.

Part I

Using Oracle Health Sciences Clinical Development Analytics

This part of the Oracle Health Sciences Clinical Development Analytics User and Administrator Guide describes how to use OHSCDA.

Part I contains the following chapters:

- Chapter 1, Getting Started with Oracle Health Sciences Clinical Development Analytics

- Chapter 2, Using Oracle Health Sciences Clinical Development Analytics

- Chapter 3, Working with Analyses

1 Getting Started with Oracle Health Sciences Clinical Development Analytics

This chapter contains the following topics:

- Overview

- Architecture

- Reporting

- Regulatory Compliance

Overview

Oracle Health Sciences Clinical Development Analytics (OHSCDA) is an analytical and transactional reporting application based on a predefined set of key performance indicators (KPIs), facts, and dimensions with support for predefined and custom reporting. OHSCDA provides rich support for merging data from multiple source databases into its single warehouse, providing a cross-enterprise view of operational data. OHSCDA also functions as a decision support system to monitor process bottlenecks and compliance deviations.

Clinical Development Organizations require insights into the following key Clinical Data Management and Clinical Trial Operations Management business processes areas that impact clinical trial performance:

- Clinical Data Collection Management: All required data must be collected with no data omitted or wrongly entered using electronic data capture.

- Clinical Data Cleanliness Management: Each discrepancy must be resolved, either by correcting the data that gave rise to it or by changing the rules that define the discrepancy.

- Study Startup and Site Activation: All sites that are selected to recruit subjects and administer the study must be activated. Impediments to site activation must be identified and resolved.

- Subject Recruitment: Study team must monitor if the subjects are enrolling, and the rate at which they are enrolling. If required, additional sites must be identified.

- Site Monitoring Visits: All internal standard operating procedures must be met and all required data relevant to subject visits must be collected properly and on time.

OHSCDA provides mechanisms to gain operational and clinical insights to and evaluate performance of your clinical trials, and take corrective action to reduce cycle times.

What Can I Do Using Oracle Health Sciences Clinical Development Analytics?

OHSCDA integrates clinical trial performance data from multiple sources (Oracle Clinical, Oracle's Siebel Clinical, and InForm) into a predefined data warehouse schema and generates both predefined and custom reports of key metrics across the clinical development spectrum. OHSCDA lets you perform the following functions:

- Extract all necessary clinical trial data from Oracle Clinical and Siebel Clinical into a predefined data warehouse, for viewing through the rich dashboard and report interface of Oracle Business Intelligence Enterprise Edition Plus (OBIEE).

- Extract such data from other database sources as well, subject to the development of separate Extract Transform Load (ETL) programs for each database source.

- Identify and merge duplicates while integrating data from multiple sources.

- View predefined analytical reports delivered with the application.

- Rapidly create new reports using the extensive predefined cycle time, quality and volume based metrics across data management and clinical operations processes.

Architecture

Figure 1-1 displays the OHSCDA architecture.

Figure 1-1 Oracle Health Sciences Clinical Development Analytics Architecture

The OHSCDA architecture includes the following principal components:

- A predefined Intelligence application, based on Oracle Business Intelligence Enterprise Edition Plus (OBIEE), including Oracle BI Presentation Services, and a predefined set of Oracle BI reports, accessible through prebuilt interactive dashboards.

- A prebuilt clinical data warehouse schema, designed to drive both predefined and custom intelligence reports.

- Oracle Data Integrator (ODI) based Extract Transform Load (ETL) programs, designed to extract clinical trial transactional data from Oracle Clinical and Siebel Clinical databases into the data warehouse schema.

- A predefined BI Server Repository including a unique mix of clinical measures (facts, dimensions), populated by the data warehouse schema.

Reporting

OHSCDA provides reports for the following key functional areas:

- Clinical Data Collection Management: Reports on the data management workload and the rates at which work is progressing to provide insights to help minimize time to data lock.

- Clinical Data Cleanliness Management: Cleanliness reports track the discrepancy-resolution workload, rates of progress, durations in various statuses, and provide drill-down detail.

- Study Startup and Site Activation: Reports on sites that have not been activated and where they are in the process provide insight to help meet the recruitment goals.

- Subject Recruitment: Reports on subject enrollment helps evaluate if additional sites are needed or if protocol amendment is necessary.

- Site Monitoring Visits: Reports analyzing key metrics across the clinical monitoring process helps maintain compliance with internal standard operating procedures.

- Risk Based Monitoring: Reports that track key risk indicators for both Study and Study-Site to help determine Study and Study-Site risk.

See Also:

- Chapter 2, Using Oracle Health Sciences Clinical Development Analytics

- Chapter 3, Working with Analyses

- Appendix A, Dashboards and Analyses

Regulatory Compliance

OHSCDA is designed as a single data-warehousing platform that facilitates integration of both non-regulated and regulated data. This single platform provides secure access to authorized users. It provides reduced total cost of ownership through reduced data integration costs and infrastructure maintenance costs, compared with multiple warehousing solutions.

The primary regulatory requirements include: (i) data tracking and (ii) Extract Transform Load (ETL) Version Management.

Tracking Data

The origin of any data displayed in a report must be traceable to its source, and all transformations applied to the data must be accessible. Data sourced from Oracle Clinical and Siebel Clinical is traced by the following criteria and rules:

- Load: When the data was loaded from the source database into the staging tables.

- Staging Mapping: The version of ETL mapping used to transform the data from source to staging table, and when it was executed.

- Target Mapping: The version of ETL mapping used to transform the data from the staging table to target tables, and when it was executed.

- Merged Dimensional Data: Records that were used to created the merged record.

- Transformations and calculations performed on the data within the OBIEE Repository can be versioned and saved permanently in a third-party versioning tool.

- Calculations can also be performed in reports managed through OBIEE Answers. The OBIEE Answers Administrator is responsible for controlling what calculations are performed, and who can perform them.

Managing ETL Versions

You can use a third-party versioning tool or in-built functionality of Informatica to manage ETL versions.

Security

Data within the data warehouse is secure from updates by unauthorized personnel, and can only be updated through controlled execution of ETL mappings.

The ability to modify ETL routines is restricted to a user group or role of ETL developers. Access to execute ETL routines is restricted to a specific privilege, which can be granted to a user group or role.

In addition, access to data is available for authorized personnel only constrained through user groups or roles.

See Also:

Oracle Clinical Administrator's Guide

2 Using Oracle Health Sciences Clinical Development Analytics

This chapter contains the following topics:

- Overview

- Accessing Oracle Health Sciences Clinical Development Analytics

- Using Oracle Business Intelligence

- Performing Common Tasks in Oracle Business Intelligence

- Navigating in Oracle Business Intelligence

- Using the Oracle BI My Account Page

Note:
The appearance of the user interface that you see in the application may vary from the figures displayed in the subsequent sections.

See Also:

Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.9)

For ease of reference, the subsequent sections contain excerpts from Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.9), altered to include specific information related to OHSCDA.

Overview

OHSCDA includes dashboards, analyses, and metrics that let you view relevant, interactive information—current as at the last date the data warehouse was refreshed.

Dashboards are access points for information. Each dashboard is designed for a specific job responsibility. For example, a data manager can access only the Data Manager - EDC, Data Manager - Paper, Study Overview and Study-Site Overview dashboards.

When you access a dashboard, the information displayed changes based on your security privileges. For example, a Data Manager for Study 101 may (at the discretion of the OHSCDA Administrator) be restricted to seeing an analysis only on the status of data processing for Study 101, while Project Managers can see data processing information across all studies in their respective project.

A dashboard contains one or more related dashboard pages. A dashboard page contains a series of related analyses. An analysis can contain a tabular summary, pivot table, or graph. You can drill down to detailed breakdown by clicking the linked data. You can also filter the data that you see in analyses using a set of parameters (called filters). Figure 2-1 displays the analysis hierarchy.

Figure 2-1 The Analysis Hierarchy

In addition to the dashboards and analyses that are packaged with OHSCDA, you can also create and manage analyses or dashboards if you have appropriate permissions. Use Oracle BI Answers to manage analyses.

OBIEE includes additional applications that are not directly used by OHSCDA. These include Oracle BI Delivers and Oracle BI Publisher. These applications extend the usefulness of the information provided by OHSCDA.

Use Oracle BI Delivers to detect specific analytic results and notify appropriate user or group about the result. Use Oracle BI Publisher to create formatted and printable analyses.

See Also:

- Chapter 3, Working with Analyses for more information about creating and managing analyses.

- Appendix B, Oracle Health Sciences Clinical Development Analytics Presentation Catalog for more information about the columns in OHSCDA that you can use to create and modify analyses.

- Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.9).

Accessing Oracle Health Sciences Clinical Development Analytics

Your security privileges determine what analyses you can see and what you can do in OHSCDA. To log in to OHSCDA, you must have a browser on your computer and a URL, username, and password provided by your company.

Logging In

1. Open your browser and enter the URL provided by your company.
Typically, the URL to access the dashboards will be

http://<system_name_or_ip_address>:<port_number>/analytics/saw.dll?Dashboard

2. Enter your user ID and password.

3. Click Sign In.
After your login credentials are authenticated, your default home page appears.

Viewing a Dashboard

Perform the following steps to view a dashboard:

1. Log on to OHSCDA.

2. Click Dashboards at the top of the page.

3. Select a dashboard.

Using Oracle Business Intelligence

Clinical organizations track and store large amounts of clinical trial data. After the data has been organized and analyzed, it can provide an organization with the metrics to measure the state of a clinical trial. Oracle BI helps end users obtain, view, and analyze the data.

Oracle Business Intelligence Presentation Services Components

From an end-user perspective, Oracle BI Presentation Services consists of the following interfaces:

Oracle Business Intelligence Catalog

The Oracle BI Presentation Catalog can be used to store the objects, such as analyses and dashboards, that users create using Oracle BI EE. Users have their own personal folder (My Folders), where they can store the objects that they create. The objects in a personal folder can be accessed only by the user who created and saved the content into that folder. Users can add sub-folders to their personal folders to organize their content in the way that is the most logical to them.

Users can also store objects in shared folders where other users or groups can access the objects. A combination of business logic security, catalog object security, and data level security determines who can view data and objects, edit objects, and delete objects from the catalog. An administrator creates and maintains the catalog's shared folder structure.

Oracle Business Intelligence Analysis Editor

Oracle BI Analysis Editor provides answers to business questions. This analysis editor interface allows users with the appropriate permissions to build and modify reports, also called analyses, that let end users explore and interact with information and present and visualize information using graphs, pivot tables, and analyses.

The results of an analysis can be formatted, saved, organized, and shared with others. An analysis can be configured to refresh results in real-time.

Analyses can be saved in the Oracle BI Presentation Catalog and integrated into OHSCDA home page or dashboards. Results can be enhanced through options such as graphing, result layout, calculation, and drill down features.

Appendix B, Oracle Health Sciences Clinical Development Analytics Presentation Catalog

Oracle Business Intelligence Interactive Home Page

The Home Page provides points of access for analytics information. When an end user accesses OHSCDA, the home page is the first page that appears.

The Home page provides a starting point for performing tasks in Oracle BI EE. The Home page is divided into sections that allow users to quickly begin a specific task, locate an object, or access technical documentation. It also includes sections that allow users to quickly access objects that have been recently viewed, created, or updated, and objects that are accessed the most often by the users assigned to the groups to which a user belongs.

Oracle Business Intelligence Interactive Dashboards

Dashboards are used to display reports that contain content specific to the needs of individual users or groups. Historical and current data sources can be merged into a single dashboard.

Users with the appropriate permissions can place results from Oracle BI Answers into dashboards for use by end users.

Oracle Business Intelligence Delivers

Oracle BI Delivers is the interface used to create Oracle Business Intelligence Alerts based on analytics results. Specific results can be detected within analyses and the appropriate people notified immediately through Web, wireless, and mobile communications channels.

Oracle BI Delivers uses intelligence bots called agents to detect specific results. Agents automatically perform a specified catalog analysis based on a defined schedule, and examine the results for a specific problem or opportunity. If the specific problem or opportunity is detected in the results, then an alert is generated and delivered to specified recipients and to subscribers to the agent, using the delivery options that are specified for each person.

Users with the appropriate permissions can use Oracle BI Delivers to set up the conditions to trigger an alert.

Note:
OHSCDA does not directly use Oracle BI Delivers. You can use this feature to extend the usefulness of the information that OHSCDA provides.

Performing Common Tasks in Oracle Business Intelligence

This section explains how to perform the following common tasks in Oracle BI:

- Exiting from Oracle Business Intelligence

- Using Online Help

- Printing an Oracle BI Dashboard or Saved Analysis

- Emailing an Oracle BI Dashboard Page or Analysis

- Exporting Oracle BI Results

- Refreshing an Oracle BI Interactive Dashboard or Oracle BI Analysis

- Refreshing Information in the Oracle BI Selection Pane

Exiting from Oracle Business Intelligence

Note:
Do not close the browser window to exit from Oracle Business Intelligence (OBI).

To exit from OBI, click Sign Out from any OHSCDA screen.

Using Online Help

Oracle Business Intelligence includes OHSCDA-specific online help for both dashboards and analyses.

Dashboard pages include hyperlinks to (i) the master OHSCDA online help page, from which you can navigate throughout the help system, and (ii) topic-specific help pages for the selected dashboard.

Analysis pages include hyperlinks to topic-specific help for the selected analysis. Table 2-1 summarizes the available help links:

Table 2-1 Accessing Online Help

Click...

on...

to access...

each dashboard page

master OHSCDA online help page.

each page within this dashboard

specific help for this dashboard. This link changes for each dashboard as per the dashboard name. For example for Study Manager dashboard it will display Study Manager Reference link.

each analysis title bar

specific help for selected analysis.

Online help opens in a new browser window. You can scroll down the help page or use hyperlinks to navigate to other topics.

Note that you can use the following icon to view the OHSCDA release version:

Printing an Oracle BI Dashboard or Saved Analysis

You can display printer-friendly versions of existing dashboards and analyses. A printer-friendly version does not contain any extraneous links or other hypertext items.

You can print using HTML or Adobe PDF (Portable Document Format). Adobe PDF is the only print option available for Oracle BI Publisher analyses. Adobe Reader 6.0 or greater is required to print using Adobe PDF.

Note:
The HTML method of printing relies on the print handling capabilities of your browser. If you do not get the results you want, select PDF to open, and then print the dashboard or analysis.

To print a dashboard or an analysis:

1. Navigate to an existing dashboard or an analysis.

2. To print an analysis, click Print, and then select Printable PDF or Printable HTML.
To print a dashboard page, click the following Page Options icon at the top of the dashboard, and select Printable HTML or Printable PDF:

- For HTML, a new window shows the selected item without the extraneous links. Select File > Print on the browser menu.

- For PDF, use the options available in the Adobe PDF window to save or print the file.

Emailing an Oracle BI Dashboard Page or Analysis

You can email a dashboard page or an analysis as an attachment. The format you use depends on your browser, such as Web Archive, Single File (.mht) in Internet Explorer or Mozilla Archive Format (.maf) in Mozilla and Firefox.

Note:
The Mozilla Archive Format capability is available as a separately downloaded plug-in.

In any browser, you can also save a dashboard page or analysis as a collection of HTML files. You can then zip and email the corresponding directory of associated files.

To email a dashboard page or analysis:

1. Navigate to the dashboard page or analysis that you want to send.

2. To email an analysis, click Print, and then select Printable HTML or Printable PDF. To email a dashboard page, locate and click the Page Options icon at the top of the dashboard, select Print and then select HTML or PDF.
A new browser window opens that contains the dashboard page or the analysis.

3. From the browser's toolbar, select File > Save As.

4. Save the file to the desired location, with the appropriate file type for your browser.

5. Send the saved attachment using an email application.

Note:
The saved attachments can also be used as a means to archive and restore analyses as they exist at a particular point in time.

Exporting Oracle BI Results

Oracle BI provides options for exporting results of an analysis or view. These appear in Oracle BI Answers as options for the Export link. The Export link can also appear with a request in a dashboard.

- PDF: This option displays the File Download dialog where you can open or save the results or view as a PDF file.

- Excel 2007+: This option displays the File Download dialog where you can open or save the results or view as an XLS file. The file is saved in HTML format. Excel controls the positioning of the HTML.

- Powerpoint 2007+: This option displays the File Download dialog where you can open or save the results or view as a PPT file.

- Web Archive (.mht): This option displays the File Download dialog where you can open or save the results or view as an MHT file. This enables you to export the underlying data for an existing analysis or view as a Web page (MHTML) file.

- Data
This option displays these options for exporting the data from the results or view:

- CSV Format: Displays the File Download dialog where you can open or save all the columns in the results or view as a CSV file. This export results in a comma-delimited list of values in a file that you can open in an application such as Excel.

- Tab delimited Format: Displays the File Download dialog where you can open or save all the columns in the results or view as a CSV file. This export results in a tab-separated list of values in a file that you can open in an application such as Excel.

- XML Format: Displays the File Download dialog where you can open or save the results or view as a TXT file. This file using the Microsoft MD Data Set standard for representing data in XML format.

To download results in Adobe PDF format:

1. Navigate to the analysis.

2. Click Export and select PDF.
The File Download dialog box appears.

3. Save the file to the desired location, or open it in PDF.

To download results in Microsoft Excel format:

1. Navigate to the analysis.

2. Click Export and select Excel 2007+.
The File Download dialog box appears.

3. Save the file to the desired location, or open it in Excel.

4. If desired, use Excel to refine the formatted results.
See Also:

Microsoft Excel documentation for more information.

To download results in Microsoft Powerpoint format:

1. Navigate to the analysis.

2. Click Export and select Powerpoint 2007+.
The File Download dialog box appears.

3. Save the file to the desired location, or open it in Powerpoint.

4. If desired, use Powerpoint to refine the formatted results.
See Also:

Microsoft Powerpoint documentation for more information.

To download results as a Web archive:

1. Navigate to the request.

2. Click Export and select Web archive (.mht).
The File Download dialog box appears.

3. Save the file on your hard drive.

To download results as a comma-separated list of values:

1. Navigate to the request.

2. Click Export and select Data > CSV Format.
The File Download dialog box appears.

3. Save the file on your hard drive.

To download results as a tab-separated list of values:

1. Navigate to the request.

2. Click Export and select Data > Tab delimited Format.

3. Save the file on your hard drive.

To download results as an extended markup file:

1. Navigate to the request.

2. Click Export and select Data > XML Format.
The File Download dialog box appears.

3. Save the file on your hard drive.

Refreshing an Oracle BI Interactive Dashboard or Oracle BI Analysis

When executing an Oracle BI Interactive Dashboard or a request, Oracle BI uses temporary storage areas, called caches, to save frequently accessed or recently accessed results. Storing certain results in cache helps to improve Oracle BI performance. You can use the Refresh feature to make sure that your request bypasses saved information in the Oracle BI Presentation Services cache, and is issued to the Oracle Business Intelligence Server for processing.

Note:
The Oracle BI Server maintains its own cache. This cache is separate from the Oracle BI Presentation Services cache.

When you select a specific dashboard or request, Oracle BI Presentation Services checks its cache to determine if the identical results have recently been requested. If so, Oracle BI Presentation Services returns the most recent results, thereby avoiding unnecessary processing by the Oracle BI Server and the back-end database. If not, the request is issued to the Oracle BI Server for processing.

If the Oracle BI Server has cached results that can satisfy your request, the results are returned from that cache. If not, Oracle BI Server issues the request to the back-end database. You cannot force your request past the Oracle BI Server's cache.

Oracle BI administrators can configure cache settings for Oracle BI Presentation Services that control what is cached and for how long. For more information, refer to Oracle Business Intelligence Presentation Services Administration Guide. For information about the Oracle BI Server cache, refer to Oracle Business Intelligence Server Administration Guide.

To refresh a dashboard or request:

1. Navigate to an existing dashboard or request.

2. To refresh an analysis, locate and click the Page Options icon at the top of the dashboard and then click Refresh.

Refreshing Information in the Oracle BI Selection Pane

The Oracle BI selection pane appears in Oracle BI Analysis Editor criteria tab. When changes have been made to the saved content or to the Oracle BI Server metadata, you can refresh the display to access the most current information.

Note:
The information available in the selection pane is determined by your permissions and responsibilities.

To refresh the information in the selection pane:

- To refresh the information for saved analyses, filters, briefing books, and dashboard content, click the Refresh icon at the top of the catalog pane.

- To refresh the view of the Oracle BI Server metadata for subject areas, click the Refresh icon at the top of the selection pane and then select Reload Server Metadata.

Navigating in Oracle Business Intelligence

This section explains basic navigation within Oracle BI.

What is Available to You After Accessing Oracle BI?

When you access Oracle BI, the first screen that is displayed is the BI home page. The Home page is divided into sections that let you quickly begin a specific task, locate an object, or access technical documentation. It also includes sections that allow you to quickly access objects that you have recently viewed, created, or updated, and objects that are accessed the most often by the users assigned to the groups to which you belong. The views that you can access are determined by your role and responsibilities

See Also:

Oracle® Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.9), for more information about the Home Page.

Using Oracle BI Global Header

The global header appears in the top right corner of the user interface and provides quick access to commonly used functions. For example, you can use the global header to begin a new task, search the Oracle BI Presentation Catalog, access the product documentation, or view a different object, without having to return to the Home page. The global header also includes the Home page link so that you can quickly access the Home page from other pages.

Table 2-2 describes the components of the Oracle BI global header.

Table 2-2 Oracle BI Global Header

Link

Description

Search

Enables you to search the catalog.

Advanced

Displays the Catalog page in search mode, where you can search for objects in the catalog. In search mode, the Search pane is displayed rather than the Folders pane within the page.

Administration

Available only if you are logged in as an administrator. Displays the "Administration page", where perform administration tasks such as managing privileges and metadata for maps. For information on the administration tasks, see Oracle Fusion Middleware System Administrator's Guide for Oracle Business Intelligence Enterprise Edition and Oracle Fusion Middleware Security Guide for Oracle Business Intelligence Enterprise Edition.

Help

Displays the following options:

- currentpage Help (where currentpage is the name of the page, editor, or tab) — Dynamically changes to display the Help topic for the current page, editor, or tab.

- Help Contents: Displays a cascading menu that provides options that link to the tables of contents for Oracle BI EE, BI Publisher, and Marketing.

- Documentation: Displays the documentation library for Oracle BI EE.

- OTN: Displays the Business Intelligence and Data Warehousing Technology Center page on the Oracle Technology Network (OTN).

- About Oracle BI EE: Displays a dialog identifying the Oracle BI EE version and copyright information.

Alerts

Available only if one or more alerts have been generated for you. Displays the "Alerts dialog", where you can manage your alerts. An alert is a notification that is generated by an agent that delivers personalized and actionable content to specified recipients and to subscribers to the agent.

Home

Displays the Home page.

Catalog

Displays the "Catalog page", where you can locate objects in the catalog and perform tasks specific to those objects.

Favorites

Displays your favorite Catalog objects, such as analyses, dashboards, and reports.

Dashboards

Contains links to all dashboards that are stored within the Dashboards sub-folder of the user's folder or any shared folder (note that dashboards not saved to the Dashboards sub-folders are not displayed from the global header's Dashboard list).

New

Displays a list of the objects that you can create. To create an object, select it from the list. The appropriate dialog or editor is displayed for you to create the object.

Open

Displays the following options:

- Open — Displays the "Open dialog", where you can select the object with which you want to work.

- Recent objects — Displays a list of the objects that you have recently viewed, created, or updated. You can use this list to select an object with which you want to work.

- Most Popular objects — Displays a list of the objects that are accessed the most often by the users that are assigned to the groups to which you belong. You can use this list to select an object with which you want to work.

Signed In As username

where username is the user name that your current session is using. Displays the following options:

- My Account — Displays the "My Account dialog", where you can specify your preferences, such as time zone, delivery devices, and delivery profile. For information about setting preferences, see "Setting Preferences".

- Act As — Available only if your organization has enabled this functionality and you have been granted the appropriate permissions. Enables you to act as another user. For information, see "Acting for Other Users".

Drilling Down in Oracle BI

Many of the results that appear in Oracle BI represent hierarchical data structures. Oracle BI metadata specifies these hierarchies, and this allows you to access the different levels of detail within them. You can drill down to an actual item in the database.

Sorting Columns in Tables in Oracle BI

In a dashboard, the column headers of tables that can be sorted will display up and down arrows when you hover over a column header. You can click a column header to sort it.

Using the Oracle BI My Account Page

From the My Account page in Oracle BI, you can perform the following actions:

- View general account information, such as your display name and user ID.

- View and modify your preferences.

- Set your time zone.

- View and modify your Oracle BI Publisher preferences.

- View and modify your delivery options for Oracle BI Delivers agents.

- View a list of users who can access your analyses and dashboards. Depending on your privilege settings, not all of these options may be available.

To display your account settings:

1. Log on to OHSCDA.

2. Click Signed in as username where username is the user name your current session is using, and the My Account link.
The My Account dialog box appears.

Setting Your Oracle BI Preferences

You can access the Preferences section of the My Account page to specify preferences such as a default dashboard, your locale, and a language in which to view the user interface screens.

To change your preferences:

1. Log on to OHSCDA.

2. Click Signed in as username where username is the user name your current session is using, and the My Account link.

3. In the Preferences section, perform one of the following actions:

- In Default Dashboard, select the dashboard you want to display when you log in to Oracle BI.

- In Locale, select the locale that you want to use for this session.

- In User Interface Language, select the language in which you want Oracle BI to appear.

- In Time Zone, select the time zone to apply when viewing content.

- In currency, select the currency in which to view currency columns in dashboards and analyses. This box is available only if the administrator has configured the userpref_currencies.xml file.

- Select Accessibility Mode to view content for Oracle BI EE in a browser or in a way that facilitates the use of a screen reader.

Setting Your Oracle BI Time Zone

You can use the time zone option to select your Oracle BI account's preferred time zone. This option allows system users who do not reside in the same physical location to override the default time zone that was set by the system administrator. For example, the Oracle BI server that sends you alerts resides in the US Pacific time zone, but your work location is in the US Central time zone. After you set the Central time zone as your preferred time zone setting, the delivered time on your alerts appears in Central time.

Your account's time zone will automatically apply to any items that you create, modify, run, receive, and print.

The date and time columns included in analyses appear according to the analysis designer's specifications. The analysis designer can force a specific time zone to appear in the column, or allow the user's default time zone to appear in the column. A clock icon will appear in the column heading, and when you mouse over this icon, the name of the time zone used in the column is displayed.

To change your time zone preference:

1. Log on to OHSCDA.

2. Click Logged in as username where username is the user name your current session is using, that (if available), and the My Account link.

3. In the preference section, select a time zone from Time Zone.

4. Click Ok.

3 Working with Analyses

Using the Oracle BI Analysis Editor, you can run or display predefined reports (delivered with OHSCDA), and you can also create or modify custom analyses.

This chapter contains the following topics:

- Predefined Analyses

- Custom Analyses

- Action Links

- Viewing Analyses With Your Apple iPhone and iPad

- Catalog Page

- Dashboard Page

- Indicators

See Also:

Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1

For ease of reference, the subsequent sections contain excerpts from Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.9), altered to include specific information related to OHSCDA.

Predefined Analyses

OHSCDA is delivered with 109 predefined analyses. A subset of these analyses is displayed on your dashboard pages based on the user group you are assigned to.

A analysis can contain data in a tabular format, pivot table, or graph. You can filter the data visible on the analysis based on certain criteria such as Study, Study Site, CRA. These filters are called prompts. Some analyses let you drill down to a more detailed analysis.

Following are some of the analysis-related tasks that you can perform:

- Create and modify analyses.

- Refresh the results.

- Print and Save analyses.

- Add analyses to the briefing book.

- Copy analyses.

See Also:

- Chapter 2, Using Oracle Health Sciences Clinical Development Analytics for more information about analysis-related tasks.

- Appendix A, Dashboards and Analyses for more information about predefined analyses.

- Oracle Health Sciences Clinical Development Analytics Secure Installation and Configuration Guide for instruction on installing OHSCDA.

- Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.9)

Viewing a Predefined Analysis

Perform the following steps to view a predefined analysis:

1. Log on to OHSCDA.

2. Using the global header, click Dashboards and select the dashboard page that contains the analysis you want to view.

Note:
Every predefined dashboard page displays the ETL Refresh Date at the bottom of the page. This date indicates the date when the data warehouse was last refreshed.

Parameters are displayed if you filter the analyses.

3. To filter the analysis based on selected criteria:

1. Select the value from the parameters displayed.

2. Click Apply.

See Also:

Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.9)

Custom Analyses

You can create a custom analysis if you have been assigned the required permissions and responsibilities. If you prefer, you can copy a pre-defined analysis and use it as a template for the new analysis.

Use the Oracle BI Answers user interface to create your own analysis. But before you proceed, consider the following points:

- Do not modify a predefined analysis. If you do, your changes will be overwritten when a new release of OHSCDA is installed. Alternatively, you can make a copy, and modify the copy.

- Define a Catalog Folder hierarchy that gives each Answers user a unique folder tree. Limit the right to move analyses into public folders to members of the OHSCDA Administrators group.

- Limit the right to place analyses onto shared dashboards to members of the OHSCDA Administrators group.

Action Links

An action link in OBIEE is a link to an action that you can embed in an analysis that, when clicked, runs an associated action. For example, an action link can open Siebel Clinical and display a particular Study-Site with Site Visits. For more information, see Oracle Business Intelligence Presentation Services Administration Guide.

The following columns can be used to identify records in source systems (such as Siebel Clinical) when creating action links back to a source system:

- AD05-19 Investigator Action Link

- AD07-09 Product Action Link

- AD08-06 Site Action Link

- AD09-15 Study Action Link

- AD10-39 Study-Site Action Link

- AD14-08 Team Member Action Link

- AD15-19 Contact Action Link

- AD16-04 Program Action Link

- AD17-04 Region Action Link

- TD01-30 Subject Action Link

Viewing Analyses With Your Apple iPhone and iPad

Oracle Business Intelligence Mobile allows you to view Oracle BI EE content on supported mobile devices such as the Apple iPhone and Apple iPad. Using Oracle Business Intelligence Mobile, you can view and analyze BI content such as analyses and dashboards, BI Publisher content, scorecard content, and content delivered by agents. Oracle Business Intelligence Mobile for Apple iPhone and Apple iPad can be downloaded from the Apple iTunes App Store. Refer to the Oracle® Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.9) for more information.

Catalog Page

The Catalog page lets you locate objects in the catalog and perform tasks specific to those objects. The objects and options that are available to you are determined by your system privileges and the permissions assigned to individual folders and objects.

To open the Catalog page, click Catalog in the Oracle BI global header.

Table 3-1 lists the components of the Catalog page.

Table 3-1 Components of Catalog Page

Component

Description

Folders Pane

Displays the catalog as a directory hierarchy or only those folders and objects that you created or marked as your favorites.

Search Pane

Provides search criteria and initiates a catalog search. The search pane appears by default when you click Advanced on the global toolbar.

Tasks Pane

Initiate tasks specific to an object. Following are the options in the tasks pane:

- Expand — Use this button to display the contents of a selected folder.

- RSS - Use this option to subscribe to RSS feed.

- Delete — Use this button to remove a folder or object that you created from the catalog. If you delete shared folders or objects, then other users who have added shared objects will lose access.

- Copy — Use to duplicate a folder or object and paste it in another directory.

- Rename — Use to change the name of a folder or object.

- Create Shortcut— Use to create a shortcut to the object or folder.

- Properties — Use to view or modify the selected object's properties.

- Permissions — Use to enable users privileges to view folders and objects.

Preview Pane

Provides a preview of the object that you selected in the Catalog area. This pane is not visible until you click the button to display it.

Location

Displays the directory path of a selected object. Use as a way to determine where you are within the directory structure.

Show Hidden Items

When you select this option, hidden folders, are displayed.

Toolbar

Following are the buttons in the toolbar. The buttons vary between object types.

- New — Use to create new objects. After you select the object to create, the object's editor displays where you can begin building the object.

- Refresh — Use to update the catalog with content or folder changes.

- Up — Use to navigate to a parent folder or directory.

- Show/Hide folders panes — Use to hide or show the Folders pane and Tasks pane.

- Search — Use to display the Search pane. Deselect this button to display the Folders pane.

- Change list view type — Use this list to select how much information about folders and objects to display in the Catalog area.

- Descriptive — Select to display the object or folder's name, type, owner, and date modified and Expand, Open, Edit, and More links. This view enables you to perform tasks directly from the object's listing.

- Details — Select to display the object or folder's name, type, owner, and date modified.

- List — Select to display object and folder name, only.

- View — Use to view the selected object.

- Edit — Use to modify a selected object using the associated editor or run a script, URL, or Web service action.

- Print — Use to print the current page or the information in the Preview pane.

- Export — Use to export a copy of an object or the object's data to a variety of formats (for example, PDF or XLS).

- Delete — Use to remove a selected object or folder from the catalog.

- Copy — Use to copy a selected object or folder to paste in another directory.

- Paste — Use to paste a copied object to another location.

Catalog Area

Workspace that displays the results of your search, opens folders to browse content, and initiates tasks specific to an object. Following are the components of the catalog area:

- Type - Use this list to specify which object type to display in the catalog area.

- Sort - This field displays if you selected either the List or Descriptive view type in the Change list view type list located in the "Catalog Page" toolbar. Use this list to specify how you want to sort the objects in the Catalog area.

- Show More Details - This field displays if you selected the Descriptive view type in the Change list view type list located in the "Catalog Page" toolbar. Use this to display more information about specific object types.

- Object/Folder Links - Use to view a list of catalog objects and to initiate a specific tasks from an object.

To view saved analyses as stored in the Catalog:

1. Log on to OHSCDA and click Catalog in the global header.

2. Expand the appropriate folder in the catalog area and select the analysis you want to view.

See Also:

Appendix B, Oracle Health Sciences Clinical Development Analytics Presentation Catalog

Dashboard Page

The dashboard page lets you view and navigate a dashboard.

To open the Dashboard page, click Dashboards in the Oracle BI global header.

Following are the components of a dashboard page:

- Page Tabs: Use the tabs across the top of the viewer to select the dashboard page to view and navigate.

- Toolbar: Contains the Page Options button, which displays the following options:

Note:
You might not see some of the options depending on you user privileges.

- Edit Dashboard — Use this button to display the Dashboard builder, where you modify the dashboard, if you have the appropriate permissions.

- Print — Use this option to print the current dashboard page as either HTML or PDF.

- Refresh — Use this option to refresh the results of analyses included in the dashboard page.

- Add to Briefing Book — Use this option to add the contents of a dashboard page to a briefing book. (This option is not available on an empty dashboard page or if the Show Add to Briefing Book box in the "Dashboard Properties dialog", has not been selected for the page.)

- Create Bookmark Link — Use this option to create a bookmark link.

- Create Prompted Link — Use this option to create a prompted link.

- Apply Saved Customization — Use this option to apply a saved customization — either a personal saved customization or a shared saved customization.

- Save Current Customization — Use this option to save your current customization.

- Edit Saved Customizations — Displays the Edit Saved Customizations dialog where you edit details of your saved customizations.

- Clear My Customization — Use this option to clear your current customization.

To view saved analyses organized by dashboard:

1. Log on to OHSCDA and click Dashboard in the global header. A drop-down of saved analyses appears.

2. Select the analysis you wish to view.

Indicators

This section describes the indicators in OHSCDA.

Study Indicators

The following section describes indicators for studies.

Study KPI Flag

The Study Key Performance Indicator (KPI) Flag provides a single red, yellow or green icon, which indicates that one or more study-level KPIs is at risk of missing a target (yellow) or has missed a target (red). If none of the KPIs is red or yellow, the Study KPI Flag shows green.

The Study KPI Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. Consequently, it only evaluates cycles that have not yet completed. For example, Protocol Approved to 1st Subject Enrolled is only evaluated if the 1st Subject has not yet been enrolled.

The Study KPI Flag evaluates the following KPIs:

- Last Subject Last Visit to Database Lock

- Protocol Approved to 1st Subject Enrolled

- Protocol Approved to 1st Site Initiated

Each KPI is evaluated based on the following rules:

Last Subject Last Visit to DB Lock

Last Subject Last Visit (LSLV) to Database (DB) Lock calculation is evaluated when LSLV is complete but DB Lock has not yet been reached.

Red

KPI at risk of missing target. The Target cycle time will be reached in the next 30 days.

High Level Reason - Missed KPI (s)

Detail Reason - Missed KPI: Last Subject Last Visit to Database Lock

Yellow

KPI has missed target. The time since LSLV is greater than the Target cycle time.

High Level Reason - KPI(s) at Risk

Detail Reason - KPI(s) at Risk (30 days): Last Subject Last Visit to Database Lock

Protocol Approved to 1st Subject Enrolled

Protocol Approved to 1st Subject Enrolled is evaluated when protocol has been approved but 1st subject has not yet been enrolled.

Red

KPI has missed target. The time since protocol approved is greater than the Target cycle time.

High Level Reason - Missed KPI (s)

Detail Reason - Missed KPI: Protocol Approved to 1st Subject Enrolled

Yellow

KPI at risk of missing target. The Target cycle time will be reached in the next 30 days.

High Level Reason - KPI(s) at Risk

Detail Reason - KPI(s) at Risk (30 days): Protocol Approved to 1st Subject Enrolled

Protocol Approved to 1st Site Initiated

Protocol Approved to 1st Site Initiated is evaluated when protocol has been approved but 1st site has not yet been initiated. If protocol has been approved and neither has the 1st site been initiated nor 1st subject enrolled, the system evaluates Protocol Approved to 1st Subject Enrolled before evaluating Protocol Approved to 1st Site Initiated.

Red

KPI has missed target. The time since protocol approved is greater than the Target cycle time.

High Level Reason - Missed KPI (s)

Detail Reason - Missed KPI: Protocol Approved to 1st Site Initiated

Yellow

KPI at risk of missing target. The Target cycle time will be reached in the next 30 days.

High Level Reason - KPI(s) at Risk

Detail Reason - KPI(s) at Risk (30 days): Protocol Approved to 1st Site Initiated

Study Milestones Flag

The Study Milestone Flag provides a single red, yellow or green icon, which indicates that one or more study-level milestones is at risk of missing a planned/latest estimate (LE) date (yellow) or has missed a planned/LE date (red). If none of the milestones is red or yellow, the Study Milestone Flag shows green.

All dates evaluate the LE date, if populated. If the LE date is not populated, the planned date is used. If neither the Planned nor LE dates is populated, the milestone is not evaluated.

The Study Milestone Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. Consequently, it only evaluates milestones where a planned or LE date exists but an actual date has not yet been entered.

The Study Milestone Flag evaluates the following milestones:

- Protocol Approved Date

- 1st Site Initiated Date

- 1st Critical Document Package Completed Date

- 1st Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

- Database Lock Date

- Clinical Study Report Date

Each milestone is evaluated based on the following rules:

Protocol Approved Date

Protocol Approved Date is evaluated only when none of the following post-protocol approval activities have occurred (Actual date is null):

- 1st Site Initiated Date

- 1st Critical Document Package Completed Date

- 1st Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

- Database Lock Date

- Clinical Study Report Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Protocol Approved Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Protocol Approved Date

1st Site Initiated Date

1st Site Initiated Date is evaluated only when none of the following activities have occurred (Actual date is null):

- 1st Critical Document Package Completed Date

- 1st Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

- Database Lock Date

- Clinical Study Report Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: 1st Site Initiated Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: 1st Site Initiated Date

1st Critical Document Package Completed Date

1st Critical Document Package Completed Date is evaluated only when none of the following activities have occurred (Actual date is null):

- 1st Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

- Database Lock Date

- Clinical Study Report Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: 1st Critical Document Package Completed Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: 1st Critical Document Package Completed Date

Last Subject Enrolled Date

Last Subject Enrolled Date is evaluated only when none of the following activities have occurred (Actual date is null):

- Last Subject Last Visit Date

- Database Lock Date

- Clinical Study Report Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Last Subject Enrolled Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Last Subject Enrolled Date

Last Subject Last Visit Date

Last Subject Last Visit Date is evaluated only when none of the following activities have occurred (Actual date is null):

- Database Lock Date

- Clinical Study Report Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Last Subject Last Visit Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Last Subject Last Visit Date

Database Lock Date

Database Lock Date is evaluated only when none of the following activities have occurred (Actual date is null):

- Clinical Study Report Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Last Subject Last Visit Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Last Subject Last Visit Date

Last Subject Last Visit Date

Last Subject Last Visit Date is evaluated only when none of the following activities have occurred (Actual date is null):

- Database Lock Date

- Clinical Study Report Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Last Subject Last Visit Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Last Subject Last Visit Date

Study Recruitment Flag

The Study Recruitment Flag provides a single red, yellow or green icon, which indicates whether recruitment is progressing normally. The Study Recruitment Flag is set up to evaluate three different scenarios:

- Enrollment Delay - The enrollment delay flag is triggered when there hasn't been an enrollment within 120 days (red) or 90 days (yellow) of 1st Site Initiated.

- Screen Failure Rate - The screen failure rate flag is triggered when the screen fail rate is 20% or more (red) or 10-20% more than the expected screen failure rate for the study.

- Enrollment Lag - The enrollment lag flag is triggered based on how much of the planned enrollment period is remaining, using Planned / LE and Actual 1st Subject Enrolled Date, and Planned / LE Last Subject Enrolled Date:

- Late Enrollment (25% or less of planned enrollment period remaining) - triggered when less than 100% of planned subjects have been enrolled and it has been more than 30 days (red) or 15-30 days (yellow) since the last enrollment.

- Mid Enrollment (25-50% of planned enrollment period remaining) - triggered when less than 100% of planned subjects have been enrolled and it has been more than 45 days (red) or 30-45 days (yellow) since the last enrollment.

- Early Enrollment (50% or more of planned enrollment period remaining) - triggered when less than 100% of planned subjects have been enrolled and it has been more than 60 days (red) or 45-60 days (yellow) since the last enrollment.

If any one of the scenarios above is red, the Study Recruitment Flag is red. If none are red and one or more is yellow, the Study Recruitment Flag is yellow. If none is red or yellow, the Study Recruitment Flag shows green.

The Study Recruitment Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. As a result, it only evaluates recruitment if the Last Subject Enrolled Date and Database Lock Dates have not yet been populated.

Each milestone is evaluated based on the following rules:

Study Enrollment Delay

Red

120 days or more have passed since 1st Site Initiated and there are no subjects enrolled.

High Level Reason - Enrollment Delay

Detail Reason - 1st Site Initiated > 120 Days Ago but no 1st Subject Enrolled

Yellow

90-120 days have passed since 1st Site Initiated and there are no subjects enrolled.

High Level Reason - Enrollment Delay

Detail Reason - 1st Site Initiated > 90 Days Ago but no 1st Subject Enrolled

Study Screen Failure Rate

Red

120 days or more have passed since 1st Site Initiated and there are no subjects enrolled.

High Level Reason - Screen Fail Rate

Detail Reason - Screen Fail Rate > 20% Variance from Expected for Study

Yellow

90-120 days have passed since 1st Site Initiated and there are no subjects enrolled.

High Level Reason - Screen Fail Rate

Detail Reason - Fail Rate between 10-20% Variance from Expected for Study

Study Enrollment Lag - Late Enrollment

Red

Less than 100% planned enrollment completed, 30 days or more have passed since last enrollment and 25% or less of enrollment period remains.

High Level Reason - Enrollment Lag

Detail Reason - 30 Days Since Last Enrollment and Less than 25% of Enrollment Period Remaining (includes % planned enrollment completed)

Yellow

Less than 100% planned enrollment completed, 15-30 days have passed since last enrollment and 25% or less of enrollment period remains.

High Level Reason - Enrollment Lag

Detail Reason - 15 Days Since Last Enrollment and Less than 25% of Enrollment Period Remaining (includes % planned enrollment completed)

Study Enrollment Lag - Mid-Enrollment

Red

Less than 100% planned enrollment completed, 45 days or more have passed since last enrollment and 25-50% of enrollment period remains.

High Level Reason - Enrollment Lag

Detail Reason - 45 Days Since Last Enrollment and 25-50% of Enrollment Period Remaining (includes % planned enrollment completed)

Yellow

Less than 100% planned enrollment completed, 30 days have passed since last enrollment and 25-50% of enrollment period remains.

High Level Reason - Enrollment Lag

Detail Reason - 30 Days Since Last Enrollment and 25-50% of Enrollment Period Remaining (includes % planned enrollment completed)

Study Enrollment Lag - Early Enrollment

Red

Less than 100% planned enrollment completed, 60 days or more have passed since last enrollment and more than 50% of enrollment period remains.

High Level Reason - Enrollment Lag

Detail Reason - 60 Days Since Last Enrollment and more than 50% of Enrollment Period Remaining (includes % planned enrollment completed)

Yellow

Less than 100% planned enrollment completed, 45-60 days have passed since last enrollment and more than 50% of enrollment period remains.

High Level Reason - Enrollment Lag

Detail Reason - 45 Days Since Last Enrollment and more than 50% of Enrollment Period Remaining (includes % planned enrollment completed)

Study Retention Flag

The Study Retention Flag provides a single red, yellow or green icon, which indicates that the early termination rate for the study is more than 20% (red) or 1-20% more than the expected early termination rate. If the actual early termination rate for the study is less than or equal to the expected rate, the Study Retention Flag shows green.

The Study Retention Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. As a result, it only evaluates studies that have an actual early term rate and where 25% or more of planned subjects have been enrolled.

Study Retention

Study Retention is evaluated when % Subjects Early Terminated is not null and where % Planned Subjects Enrolled in the study is greater than or equal to 25%.

Red

Actual early termination rate is 20% or more over expected early termination rate for the study.

High Level Reason - Early Term Rate

Detail Reason - Early Termination Rate > 20% over Expected for Study

Yellow

Actual early termination rate is between 1-20% over expected early termination rate for the study.

High Level Reason - Early Term Rate

Detail Reason - Early Termination Rate between 1-20% over Expected for Study

Study-Region Indicators

The following section describes indicators for study-regions.

Study-Region Milestones Flag

The Study-Region Milestone Flag provides a single red, yellow or green icon, which indicates that one or more study-region-level milestones is at risk of missing a planned/latest estimate (LE) date (yellow) or has missed a planned/LE date (red). If none of the milestones is red or yellow, the Study-Region Milestone Flag shows green.

All dates evaluate the LE date, if populated. If the LE date is not populated, the planned date is used. If neither the Planned nor LE dates are populated, the milestone is not evaluated.

The Study-Region Milestone Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. As a result, it only evaluates milestones where a planned or LE date exists but an actual date has not yet been entered.

The Study Milestone Flag evaluates the following milestones:

- 1st Site Initiated Date

- 1st Critical Document Package Completed Date

- 1st Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

Each milestone is evaluated based on the following rules:

1st Site Initiated Date

1st Site Initiated Date is evaluated only when none of the following activities have occurred (Actual date is null):

- 1st Critical Document Package Completed Date

- 1st Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: 1st Site Initiated Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: 1st Site Initiated Date

1st Critical Document Package Completed Date

1st Critical Document Package Completed Date is evaluated only when none of the following activities have occurred (Actual date is null):

- 1st Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: 1st Critical Document Package Completed Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: 1st Critical Document Package Completed Date

Last Subject Enrolled Date

Last Subject Enrolled Date is evaluated only when none of the following activities have occurred (Actual date is null):

- Last Subject Last Visit Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Last Subject Enrolled Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Last Subject Enrolled Date

Last Subject Last Visit Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Last Subject Last Visit Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Last Subject Last Visit Date

Study-Region Recruitment Flag

The Study-Region Recruitment Flag provides a single red, yellow or green icon, which indicates whether recruitment is progressing normally. The Study Recruitment Flag is set up to evaluate three different scenarios:

- Screening Delay - The screening delay flag is triggered when there hasn't been a first subject screened within 90 days (red) or 60 days (yellow) of 1st Site Initiated for this study-region.

- Enrollment Delay - The enrollment delay flag is triggered when there hasn't been an enrollment within 120 days (red) or 90 days (yellow) of 1st Site Initiated for this study-region.

- Screen Failure Rate - The screen failure rate flag is triggered when the screen fail rate for this study-region is 20% or more (red) or 10-20% more than the expected screen failure rate for the study.

- Enrollment Lag - The enrollment lag flag is triggered when there is at least one subject enrolled, there is less than 50% planned enrollment completed, and it's been more than 60 days (red) or 90 days (yellow) since the last enrollment for this study-region.

If any one of the scenarios above is red, the Study Recruitment Flag is red. If none are red and one or more is yellow, the Study Recruitment Flag is yellow. If none is red or yellow, the Study Recruitment Flag shows green.

The Study Recruitment Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. As a result, it only evaluates recruitment if the Last Subject Enrolled Date and Database Lock Dates have not yet been populated.

Each milestone is evaluated based on the following rules:

Study-Region Enrollment Delay

Red

120 days or more have passed since 1st Site Initiated and there are no subjects enrolled.

High Level Reason - Enrollment Delay

Detail Reason - 1st Site Initiated > 120 Days Ago but no 1st Subject Enrolled

Yellow

90-120 days have passed since 1st Site Initiated and there are no subjects enrolled.

High Level Reason - Enrollment Delay

Detail Reason - 1st Site Initiated > 90 Days Ago but no 1st Subject Enrolled

Study-Region Screen Failure Rate

Red

120 days or more have passed since 1st Site Initiated and there are no subjects enrolled.

High Level Reason - Screen Fail Rate

Detail Reason - Screen Fail Rate > 20% Variance from Expected for Study

Yellow

90-120 days have passed since 1st Site Initiated and there are no subjects enrolled.

High Level Reason - Screen Fail Rate

Detail Reason - Fail Rate between 10-20% Variance from Expected for Study

Study-Region Enrollment Lag

Red

Site enrollment is less than 50% and more than 60 days have passed since last enrollment.

High Level Reason - Enrollment Lag

Detail Reason - Site Enrollment Under 50% and > 60 Days Since Last Enrollment

Yellow

Site enrollment is less than 50% and 30-60 days have passed since last enrollment.

High Level Reason - Enrollment Lag

Detail Reason - Site Enrollment Under 50% and > 30 Days Since Last Enrollment

Study-Region Retention Flag

The Study-Region Retention Flag provides a single red, yellow or green icon, which indicates that the early termination rate for the study-region is more than 20% (red) or 1-20% more than the expected early termination rate for the study. If the actual early termination rate for the study is less than or equal to the expected rate, the Study-Region Retention Flag shows green.

The Study-Region Retention Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. As a result, it only evaluates study-regions that have an actual early term rate and where 25% or more of planned subjects have been enrolled.

Study-Region Retention

Study-Region Retention is evaluated when % Subjects Early Terminated is not null and where % Planned Subjects Enrolled in the study-region is greater than or equal to 25%.

Red

Actual early termination rate is 20% or more over expected early termination rate for the study.

High Level Reason - Early Term Rate

Detail Reason - Early Termination Rate > 20% over Expected for Study

Yellow

Actual early termination rate is between 1-20% over expected early termination rate for the study.

High Level Reason - Early Term Rate

Detail Reason - Early Termination Rate between 1-20% over Expected for Study

Study-Site Indicators

The following section describes indicators for study-sites.

Study-Site Milestones Flag

The Study-Site Milestone Flag provides a single red, yellow or green icon, which indicates that one or more study-site-level milestones is at risk of missing a planned/latest estimate (LE) date (yellow) or has missed a planned/LE date (red). If none of the milestones is red or yellow, the Study-Site Milestone Flag shows green.

All dates evaluate the LE date, if populated. If the LE date is not populated, the planned date is used. If neither the Planned nor LE dates are populated, the milestone is not evaluated.

The Study-Site Milestone Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. As a result, it only evaluates milestones where a planned or LE date exists but an actual date has not yet been entered.

The Study Milestone Flag evaluates the following milestones:

- Site Initiated Date

- Critical Document Package Completed Date

- 1st Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

Each milestone is evaluated based on the following rules:

Site Initiated Date

Site Initiated Date is evaluated only when none of the following activities have occurred (Actual date is null):

- Critical Document Package Completed Date

- Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Site Initiated Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Site Initiated Date

Critical Document Package Completed Date

Critical Document Package Completed Date is evaluated only when none of the following activities have occurred (Actual date is null):

- Subject Enrolled Date

- Last Subject Enrolled Date

- Last Subject Last Visit Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Critical Document Package Completed Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Critical Document Package Completed Date

Last Subject Enrolled Date

Last Subject Enrolled Date is evaluated only when none of the following activities have occurred (Actual date is null):

- Last Subject Last Visit Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Last Subject Enrolled Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Last Subject Enrolled Date

Last Subject Last Visit Date

Red

The Planned or LE date is in the past.

High Level Reason - Missed Milestone(s)

Detail Reason - Missed Milestone: Last Subject Last Visit Date

Yellow

The Planned or LE Date is in the next 30 days.

High Level Reason - Milestone at Risk

Detail Reason - Milestone at Risk: Last Subject Last Visit Date

Study-Site Recruitment Flag

The Study-Site Recruitment Flag provides a single red, yellow or green icon, which indicates whether recruitment is progressing normally. The Study Recruitment Flag is set up to evaluate four different scenarios:

- Screening Delay - The screening delay flag is triggered when there hasn't been a first subject screened within 90 days (red) or 60 days (yellow) of Site Initiated for this study-site.

- Enrollment Delay - The enrollment delay flag is triggered when there hasn't been an enrollment within 120 days (red) or 90 days (yellow) of Site Initiated for this study-site.

- Screen Failure Rate - The screen failure rate flag is triggered when the screen fail rate for this study-site is 20% or more (red) or 10-20% more than the expected screen failure rate for the study.

- Enrollment Lag - The enrollment lag flag is triggered when there is at least one subject enrolled, there is less than 50% planned enrollment completed, and it's been more than 60 days (red) or 90 days (yellow) since the last enrollment for this study-site.

If any one of the scenarios above is red, the Study Recruitment Flag is red. If none are red and one or more is yellow, the Study Recruitment Flag is yellow. If none is red or yellow, the Study Recruitment Flag shows green.

The Study Recruitment Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. As a result, it only evaluates recruitment if the Last Subject Enrolled Date and Database Lock Dates have not yet been populated.

Each milestone is evaluated based on the following rules:

Study-Site Enrollment Delay

Red

120 days or more have passed since Site Initiated and there are no subjects enrolled.

High Level Reason - Enrollment Delay

Detail Reason - 1st Site Initiated > 120 Days Ago but no 1st Subject Enrolled

Yellow

90-120 days have passed since Site Initiated and there are no subjects enrolled.

High Level Reason - Enrollment Delay

Detail Reason - 1st Site Initiated > 90 Days Ago but no 1st Subject Enrolled

Study-Site Screen Failure Rate

Red

120 days or more have passed since Site Initiated and there are no subjects enrolled.

High Level Reason - Screen Fail Rate

Detail Reason - Screen Fail Rate > 20% Variance from Expected for Study

Yellow

90-120 days have passed since Site Initiated and there are no subjects enrolled.

High Level Reason - Screen Fail Rate

Detail Reason - Fail Rate between 10-20% Variance from Expected for Study

Study-Site Enrollment Lag

Red

Site enrollment is less than 50% and more than 60 days have passed since last enrollment.

High Level Reason - Enrollment Lag

Detail Reason - Site Enrollment Under 50% and > 60 Days Since Last Enrollment

Yellow

Site enrollment is less than 50% and 30-60 days have passed since last enrollment.

High Level Reason - Enrollment Lag

Detail Reason - Site Enrollment Under 50% and > 30 Days Since Last Enrollment

Study-Site Retention Flag

The Study-Site Retention Flag provides a single red, yellow or green icon, which indicates that the early termination rate for the study-site is more than 20% (red) or 1-20% more than the expected early termination rate for the study. If the actual early termination rate for the study is less than or equal to the expected rate, the Study-Site Retention Flag shows green.

The Study-Site Retention Flag is intended for use as an actionable measure, identifying situations where you may be able to affect the outcome in some way. As a result, it only evaluates study-sites that have an actual early term rate and where 25% or more of planned subjects have been enrolled.

Study-Site Retention

Study-Site Retention is evaluated when % Subjects Early Terminated is not null and where % Planned Subjects Enrolled in the study-site is greater than or equal to 25%.

Red

Actual early termination rate is 20% or more over expected early termination rate for the study.

High Level Reason - Early Term Rate

Detail Reason - Early Termination Rate > 20% over Expected for Study

Yellow

Actual early termination rate is between 1-20% over expected early termination rate for the study.

High Level Reason - Early Term Rate

Detail Reason - Early Termination Rate between 1-20% over Expected for Study

Part II

Appendixes

Part II contains the following appendixes:

- Appendix A, Dashboards and Analyses

- Appendix B, Oracle Health Sciences Clinical Development Analytics Presentation Catalog

A Dashboards and Analyses

This section describes predefined dashboards and analyses delivered with Oracle Health Sciences Clinical Development Analytics (OHSCDA):

- Oracle Health Sciences Clinical Development Analytics Dashboards

- Oracle Health Sciences Clinical Development Analytics Analyses

Oracle Health Sciences Clinical Development Analytics Dashboards

OHSCDA is delivered with seven dashboards. These dashboards can be accessed by users with a specific job responsibility and security privileges. Each dashboard has tabbed pages that displays reports.

OHSCDA includes the following dashboards:

- CRA Dashboard

- Data Manager - EDC Dashboard

- Data Manager - Paper Dashboard

- Executive Dashboard

- Region Manager Dashboard

- Study Manager Dashboard

- Study Overview Dashboard

- Study-Region Overview Dashboard

- Study-Site Overview Dashboard

- Index Dashboard

Log on to OHSCDA, and select the dashboard you want to view.

Note:
If Oracle Clinical (OC) and InForm are not your source systems for OHSCDA, you must disable the data management dashboards (Data Manager - EDC and Data Manager - Paper).

1. Log on to OHSCDA as a user with the administrator role.

2. Click Catalog.

3. Under Folders on the left pane, navigate to Shared Folders > OCDA > Dashboards > Data Manager - EDC.

4. Under Tasks on the left pane, click Permissions.
The Permissions dialog box appears.

5. Select No Access from the drop-down list of the relevant account.

6. Click OK.

7. Perform steps 3 through 6 for the Data Manager - Paper dashboard.

CRA Dashboard

This is the basic dashboard for a Clinical Research Associate (CRA). It provides some initial reports for a CRA, and is intended as starting point for an implementation.

This dashboard can be accessed by Study Manager, Executive, Region Manager, and CRA. It provides reports related to site status and performance, subject recruitment and retention, site monitoring, and document tracking.

This dashboard includes the following prompts, which are common to all its pages:

- CRA: Lists All CRAs within a Study (required)

- Study: Lists all Studies.

CRA Dashboard Pages

This dashboard includes the following tabbed pages:

- CRA Overview Page

- Sites to Monitor Page

- Study-Site Milestones Page

- Initiating & Recruiting Sites Page

- Monitoring Metrics Page

- Top Investigators Page

- Site Document List Page

- eCRF Workload Page

- Performance Page

- Map of Study Sites Page

CRA Overview Page

Displays reports on which monitoring reports require completion or approval, as well as lists study-sites with key information and an indicator of study-site health.

The CRA Overview page includes the following reports:

- Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

- Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)

- Outstanding Follow up Items (CRA View) (Report CDA-CO-806)

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Sites to Monitor Page

Displays reports detailing length of time since initiation or last monitoring visit.

The Sites to Monitor page includes the following reports:

- Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

- Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

- Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

- Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

- Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

- Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

- Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

Study-Site Milestones Page

Displays a report that lists study-sites with key milestone dates.

The Study-Site Milestones page includes the following page-specific prompts:

- Study-Site ID #: Lists Sites within a Study, by site number.

- Study-Site Status: Lists the Statuses of a Study-Site.

- Study Region: Lists the Regions for a Study.

- Principal Investigator: Lists the Principal Investigators for a Study-Site.

The Study-Site Milestones page includes the following reports:

- Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

- Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

- Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

- Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

- Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

- Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

Initiating & Recruiting Sites Page

Displays reports on uninitiated sites and documents, and initiated sites and recruitment.

The Initiating and Recruiting Sites page includes the following page-specific prompts:

- Study-Site ID #: Lists Sites within a Study, by site number.

- Study-Site Status: Lists the Statuses of a Study-Site.

- Study Region: Lists the Regions for a Study.

- Principal Investigator: Lists the Principal Investigators for a Study-Site.

The Initiating and Recruiting page includes the following reports:

- Uninitiated Sites (Report CDA-CO-304)

- Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

Monitoring Metrics Page

Displays reports on cycle times for monitoring report completion and approval, as well as site visit frequency.

The Monitoring Metrics page includes the following page-specific prompts:

- Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Monitoring Metrics page includes the following reports:

- Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

- # Follow Up Items by Type (Multiple Study-Sites) (Report CDA-CO-810)

- Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

Study-Site Milestones Page

Displays a report that lists study-sites with key milestone dates.

The Study-Site Milestones page includes the following page-specific prompts:

- Study-Site ID #: Lists Sites within a Study, by site number.

- Study-Site Status: Lists the Statuses of a Study-Site.

- Study Region: Lists the Principal Investigators for a Study-Site.

This page includes the following reports:

- Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

- Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

- Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

- Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

- Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

- Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

- Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

Top Investigators Page

Displays reports showing the top N investigators by % site enrollment completed or total enrollment. Also displays top investigators' contribution compared to all other investigators.

The Top Investigators page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Top Investigators, Total Enrollment (Report CDA-CO-701)

- Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

Site Document List Page

Displays a report that lists document tracking information for site documents.

The Site Document List page includes the following page-specific prompts:

- Study-Site ID #: Lists Sites within a Study, by site number.

- Study-Site Status: Lists the Statuses of a Study-Site.

- Study Region: Lists the Regions for a Study.

- Principal Investigator: Lists the Principal Investigators for a Study-Site.

- Activity Type: Lists the Activity Types for documents.

- Document Name: Lists the Document Names.

- Document Sent Date Between: Date range for Document Sent Date.

- Document Received Date Between: Date range for Document Received Date.

- Document Expiration Date Between: Date range for Document Expiration Date.

The Site Document List page includes the following report:

- Documents List (Multiple Study-Sites) (Report CDA-CO-601)

eCRF Workload Page

Displays reports on the current workload.

This eCRF Workload page includes the following reports:

- Key EDC Processing Volumes (Report CDA-DM-305)

Performance Page

Displays reports on key cycle times.

The Performance page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Performance page includes the following reports:

- Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

- Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

- Key EDC Cycle Times (Report CDA-DM-300)

- Average Days from Complete to Initially Approved (Report CDA-DM-325)

- Average Days from Complete to Initially Verified (Report CDA-DM-330)

Map of Study Sites Page

The Map of Study Sites page includes the following report:

- Detail Study-Site Map (Report CDA-CO-1201)

Data Manager - EDC Dashboard

This dashboard is the Data Management dashboard for EDC studies. It can be accessed by Data Manager, Study Manager, and Region Manager. It provides numerous reports and charts to monitor performance of EDC studies.

The Data Manager - EDC dashboard includes these prompts, which are common to all its pages:

- Study: Lists Studies within a Program.

- Study Site: Lists Sites within a Study.

The eCRF Workload, Discrepancy Workload, Quality, Key Rates and Performance pages also include the following prompts:

- Sponsor: Lists the name of the Sponsor companies for which this study is being conducted.

- Program: Lists the name of the Programs that owns the Study.

Data Manager - EDC Dashboard Pages

This dashboard includes the following tabbed pages:

- Home Page

- eCRF Workload Page

- Discrepancy Workload Page

- Quality Page

- Key Rates Page

- Performance Page

- Study Discrepancies Page

- Study Processing Summary Page

- Study Processing Detail Page

Home Page

Displays key study based reports.

The Home page includes the following page-specific prompts:

- Metric is in Bottom: Supplemental prompt for those reports that might display a long list of metrics.

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Home page includes the following reports:

- Average Days Discrepancy (Query) Open (Report CDA-DM-205)

- Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

- Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

- Approval & Verification Rates - Worst Performers (Report CDA-DM-350)

eCRF Workload Page

Displays reports on the current workload.

The eCRF Workload page includes the following reports:

- Key EDC Processing Volumes (Report CDA-DM-305)

Discrepancy Workload Page

Displays reports on discrepancy workload.

The Discrepancy Workload page includes the following reports:

- Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

- Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

- Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

Quality Page

Displays reports on the key quality indicators.

The Quality page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Quality page includes the following reports:

- Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

- Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

Key Rates Page

Displays reports on the key performance rates.

The Key Rates page includes the following page-specific prompts:

- Metric is in Bottom: Supplemental prompt for those reports that might display a long list of metrics.

The Key Rates page includes the following reports:

- Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)

- Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)

Performance Page

Displays reports on key cycle times.

The Performance page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Performance page includes the following reports:

- Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

- Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

- Key EDC Cycle Times (Report CDA-DM-300)

- Average Days from Complete to Initially Approved (Report CDA-DM-325)

- Average Days from Complete to Initially Verified (Report CDA-DM-330)

Study Discrepancies Page

Displays reports on the key study based discrepancy indicators.

The Study Discrepancies page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Study Discrepancies page includes the following reports:

- Average Days Discrepancy (Query) Open (Report CDA-DM-205)

- Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

- Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

Study Processing Summary Page

Displays reports on eCRFs waiting processing summary.

The Study Processing Summary page includes the following page-specific prompts:

- Subject ID: Lists IDs for the subject about whom the data were collected.

The Study Processing Summary page includes the following reports:

- Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

Study Processing Detail Page

Displays reports on eCRFs waiting processing detail.

The Study Processing Detail page includes the following reports:

- Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

Data Manager - Paper Dashboard

This dashboard is Data Management dashboard for paper studies. It can be accessed by Data Manager, Study Manager, and Region Manager. It provides numerous reports and charts to monitor performance of Paper studies.

This dashboard includes the following prompts, which are common to all its pages:

- Study: Lists Studies within a Program.

- Study Site: Lists Sites within a Study.

The Page Workload, Discrepancy Workload, Quality and Performance pages also include the following prompts:

- Sponsor: Lists the name of the Sponsor companies for which this study is being conducted.

- Program: Lists the name of the Programs that owns the Study.

Data Manager - Paper Dashboard Pages

This dashboard includes the following tabbed pages:

- Home Page

- Page Workload Page

- Discrepancy Workload Page

- Quality Page

- Performance Page

- Study Processing Summary Page

- Study Processing Detail Page

Home Page

Displays key study based reports.

The Home page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Home page includes the following reports:

- Average Days Discrepancy (Query) Open (Report CDA-DM-205)

- Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

- Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

- Key Paper Processing Volumes (Report CDA-DM-405)

- Pages Awaiting Entry Completion (Report CDA-DM-450)

Page Workload Page

Displays reports on the current workload.

The Page Workload page includes the following reports:

- Key Paper Processing Volumes (Report CDA-DM-405)

Discrepancy Workload Page

Displays reports on the discrepancy workload.

The Discrepancy Workload page includes the following reports:

- Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

- Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

- Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

Quality Page

Displays reports on the key quality indicators.

The Quality page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Quality page includes the following reports:

- Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

- Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

Performance Page

Displays reports on the key performance rates.

The Performance page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Performance page includes the following reports:

- Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

- Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

- Key Cycle Times for Paper Studies (Report CDA-DM-400)

- Paper Processing - Longest Cycle Times (Report CDA-DM-415)

Study Processing Summary Page

Displays reports on paper CRFs waiting processing summary.

The Study Processing Summary page includes the following page-specific prompts:

- Subject ID: Lists IDs for the subject about whom the data were collected.

The Study Processing Summary page includes the following reports:

- Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

Study Processing Detail Page

Displays reports on paper CRFs waiting processing detail.

The Study Processing Detail page includes the following reports:

- Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

Executive Dashboard

This dashboard can be accessed by an Executive. This dashboard includes the following prompts, which are common to all its pages:

- Program: Lists the name of the Programs that owns the Study.

- Therapeutic Area

- Study-phase

- Protocol Approved Date

- Clinical Study Report Date

Executive Dashboard Pages

This dashboard includes the following tabbed pages:

- Overview Page

- KPI Summary Page

- Site Performance Summary Page

- Study List Page

- Top Investigators Page

- Study-Site Map Page

Overview Page

Displays report links with the following attributes:

- Section Title - Study Performance Reports

- Show Section Header - True

- Show Section Title - True

- Collapsible - False

The Overview page includes the following page-specific prompt:

- Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The Overview page includes the following reports:

- Study List - KPI Performance (Report CDA-CO-904)

- Study List - Milestone Performance (Report CDA-CO-109)

- Number of Studies (Report CDA-CO-1001)

- Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)

- Executive Study-Site Map (Report CDA-CO-1203)

KPI Summary Page

The KPI Summary page includes the following page-specific prompt:

- Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The KPI Summary page includes the following KPI Summary reports:

- KPI Summary - Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)

- KPI Summary - Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)

- KPI Summary - CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)

- KPI Summary - LSLV to Database Lock (Executive View) (Report CDA-CO-906)

- KPI Summary - Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)

- KPI Summary - Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)

Site Performance Summary Page

The Site Performance Summary page includes the following reports:

- Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)

- Site Recruitment Performance (Report CDA-CO-413)

Study List Page

The Study List page includes the following page-specific prompts:

- Study: Lists Studies within a Program.

- Study Status: Lists Study Status for a Study.

- Study Manager: List Study Manager for a Study.

The Study List page includes the following report:

- Detailed Study Milestones Report (Report CDA-CO-102)

Top Investigators Page

The Top Investigators page includes the following page-specific prompt:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following report:

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

- Top Investigators, Total Enrollment (Report CDA-CO-701)

Study-Site Map Page

The Study-Site Map page includes the following report:

- High Level Study-Site Map (Report CDA-CO-1202)

Region Manager Dashboard

This dashboard can be accessed by Study Manager, Executive, and Region Manager. This dashboard includes the following prompts, which are common to all its pages:

- Study-Region Manager

- Region Name

- Program

- Therapeutic Area

- Protocol Approved Date

- Clinical Study Report Date

Region Manager Dashboard Pages

This dashboard includes the following tabbed pages:

- Overview Page

- Visit Reports & Follow Up Items Page

- Milestones and Schedule Page

- KPI Summary Page

- Monitoring Metrics Page

- Initiating and Recruiting Study Regions Page

- Top Investigators Page

- Map of Study Sites Page

Overview Page

Displays report links with the following attributes:

- Section Title - Study-Region Performance Reports

- Show Section Header - True

- Show Section Title - True

- Collapsible - False

The Overview page includes the following reports:

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

- Study Regions with Red or Yellow Performance Flag - Data Management Detail View (Report CDA-CO-1200A)

- Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)

- Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)

- Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)

- Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)

- Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Visit Reports & Follow Up Items Page

The Visit Reports & Follow Up Items page includes the following reports:

- Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

- Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

- Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

- Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

Milestones and Schedule Page

The Milestones and Schedule page includes the following report:

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)

- Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)

- Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)

- Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)

- Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)

KPI Summary Page

The KPI Summary page includes the following reports:

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

- Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)

- KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

- KPI Summary - Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

- KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

Monitoring Metrics Page

The Monitoring Metrics page includes the following page-specific prompts:

- Site Visit Type: Lists types of site visits.

- Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

- Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The Monitoring Metrics page includes the following reports:

- Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

- Key Performance Indicators Over Time - Monitoring (Region Manager) (Report CDA-CO-1112)

- Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

- # Follow Up Items by Type (Multiple Study-Sites) (Report CDA-CO-810)

Initiating and Recruiting Study Regions Page

The Initiating and Recruiting Study Regions page includes the following reports:

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Top Investigators Page

The Top Investigators page includes the following page-specific prompt:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

- Top Investigators, Total Enrollment (Report CDA-CO-701)

Map of Study Sites Page

The Map of Study Sites page includes the following report:

- High Level Study-Site Map (Report CDA-CO-1202)

Study Manager Dashboard

This dashboard can be accessed by Study Manager, Executive, and Region Manager. It provides reports related to study status and performance, subject recruitment and retention, site monitoring metrics, and investigator performance.

This dashboard includes the following prompts, which are common to all its pages:

- Program: Lists the name of the Programs that owns the Study.

- Study: Lists Studies within a Program.

- Study Manager: Lists Study Manager for a Study.

- Study Status: Lists Study Status for a Study.

Study Manager Dashboard Pages

This dashboard includes the following tabbed pages:

- Study Manager Overview Page

- Initiating & Recruiting Studies Page

- Monitoring Metrics Page

- Top Investigators Page

- KPI Summary Page

- Map of Study Sites Page

Study Manager Overview Page

Displays report links with the following attributes:

- Section Title - Study Performance Reports

- Show Section Header - True

- Show Section Title - True

- Collapsible - False

The Study Manager Overview page includes the following reports:

- Study List - KPI Performance (Report CDA-CO-904)

- Study List - Milestone Performance (Report CDA-CO-109)

- Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

Initiating & Recruiting Studies Page

Displays reports on studies actively initiating and actively recruiting.

The Initiating & Recruiting Studies page includes the following reports:

- Study List - Initiation Details (Report CDA-CO-305)

- Study List - Recruitment Details (Report CDA-CO-406)

Monitoring Metrics Page

Displays reports on monitoring reports awaiting approval, outstanding follow up items, and monitoring report completion and approval cycle times.

The Monitoring Metrics page includes the following page-specific prompts:

Year/Month Between: Supplemental prompt for those reports that include charts displaying data over time.

Site Visit Type: Lists types of site visits.

The Monitoring Metrics page includes the following reports:

- Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

- Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

- Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

- Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

Top Investigators Page

Displays reports showing the top N investigators by % site enrollment completed or total enrollment. Also, displays top investigators' contribution compared to all other investigators.

The Top Investigators page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Top Investigators, Total Enrollment (Report CDA-CO-701)

- Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

KPI Summary Page

The KPI Summary page includes the following page-specific prompt:

- Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The KPI Summary page includes the following reports:

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

- Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)

- KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

- KPI Summary - Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

- KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

Map of Study Sites Page

The Map of Study Sites page includes the following report:

- High Level Study-Site Map (Report CDA-CO-1202)

Study Overview Dashboard

This dashboard can be accessed by any user. It provides reports related to study status and performance, site performance within the study, subject recruitment and retention, investigator performance, site performance, study region performance, site monitoring, and document tracking.

This dashboard includes the following prompts, which are common to all its pages:

- Program: Lists the name of the Programs that owns the Study.

- Study: Lists Studies within a Program.

- Study Status: Lists Study Status for a Study.

- Study Manager: Lists Study Manager for a Study.

Study Overview Dashboard Pages

This dashboard includes the following tabbed pages:

- Study Overview Page

- Study-Site Milestones Page

- Screening Overview Page

- Recruitment Overview Page

- Retention Overview Page

- Top Investigators Page

- Non Performing Investigators Page

- Site Performance Page

- Site Region Performance Page

- Monitoring Metrics Page

- Site Document List Page

- Site Document Metrics Page

- Study Team Page

- Map of Study Sites Page

- Risk Profile Page

- Protocol Deviations Page

Study Overview Page

Displays reports that contain identifying information for a study as well has high level overviews of milestones and subject recruitment and retention.

The Study Overview page includes the following page-specific prompts:

- Study Region: Supplemental prompt for those reports that don't make sense unless run for a small set of study-sites or study regions.

- Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

The Study Overview page includes the following reports:

- Study Information (Report CDA-CO-103)

- Subject Retention (Report CDA-CO-504)

- Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

- Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

Study-Site Milestones Page

Displays a report that lists all sites for the study and which milestones have been met.

The Study-Site Milestones page includes the following page-specific prompts:

- Study Region: Supplemental prompt for those reports that don't make sense unless run for a small set of study-sites or study regions.

- Study-Site ID#: List of Study-Sites for a Study.

The Study-Site Milestones page includes the following reports:

- Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)

- Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)

- Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)

- Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)

- Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)

- Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)

- Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)

Screening Overview Page

Displays reports on a study's progress toward screening, including screen failure reason analysis.

The Screening Overview page includes the following page-specific prompt:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Screening Overview page includes the following reports:

- Screening Overview (Study Level) (Report CDA-CO-407)

- Screening vs. Enrollment by Region (Report CDA-CO-400)

- Screen Failure Reason by Site (Report CDA-CO-300)

- Screen Failure Reason (Report CDA-CO-425)

Recruitment Overview Page

Displays reports on a study's progress toward recruitment, including recruitment over time.

The Recruitment Overview page includes the following page-specific prompts:

- Study Region: Supplemental prompt for those reports that don't make sense unless run for a small set of study-sites or study regions.

- Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

The Recruitment Overview page includes the following reports:

- Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

- Study-Region List and Recruitment Counts (Report CDA-CO-404)

Retention Overview Page

Displays reports on a study's retention pattern, including withdrawn reason analysis and retention vs. enrollment over time.

The Retention Overview page includes the following page-specific prompts:

- Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Retention Overview page includes the following reports:

- Subject Retention (Study Level) (Report CDA-CO-503)

- Subject Retention Over Time (Study Level) (Report CDA-CO-501)

- Withdrawn Reason (Report CDA-CO-505)

- Withdrawn Reason Overview (Report CDA-CO-508)

Top Investigators Page

Displays reports showing the top N investigators by % site enrollment completed or total enrollment. Also, displays top investigators' contribution compared to all other investigators.

The Top Investigators page includes the following page-specific prompts:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Top Investigators, Total Enrollment (Report CDA-CO-701)

- Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

Non Performing Investigators Page

Displays reports that list initiated sites / investigators enrolling no subjects, or only one subject.

The Non Performing Investigators page includes the following reports:

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

- Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

Site Performance Page

Displays reports on the distribution of top performing and non performing investigators.

The Site Performance page includes the following reports:

- Site Recruitment Performance - Single Study (Report CDA-CO-416)

- Site Recruitment Performance (Report CDA-CO-413)

- Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)

- Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

Site Region Performance Page

Displays reports on the distribution of enrollment across study regions, and by site for each study region.

The Study Region Performance page includes the following reports:

- Total Subject Enrollment by Region (Report CDA-CO-410)

- Subject Enrollment by Region (Report CDA-CO-414)

- Enrollment Overview By Site (Report CDA-CO-426)

Monitoring Metrics Page

Displays reports on patterns in site visit length and monthly enrollment, as well as lists outstanding follow up items for the study.

The Monitoring Metrics page includes the following page-specific prompts:

- Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

- Site Visit Type: Lists types of site visits.

The Monitoring Metrics page includes the following reports:

- Site Visit Analysis (Report CDA-CO-821)

- Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

- Outstanding Follow up Items - Study Overview (Report CDA-CO-805)

Site Document List Page

Displays a report that lists document tracking information for study documents.

The Site Document List page includes the following report:

- Study Documents List (Report CDA-CO-600)

Site Document Metrics Page

Displays reports on cycle times for site document collection.

The Site Document Metrics page includes the following page-specific prompt:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Site Document Metrics page includes the following reports:

- Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

- Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

- Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

Study Team Page

The Study Team page includes the following report:

- Study Team Member List (Report CDA-CO-111)

Map of Study Sites Page

The Map of Study Sites page includes the following report:

- High Level Study-Site Map (Report CDA-CO-1202)

Risk Profile Page

Provides a snapshot of multiple study level risk indictors used in Risk Based Monitoring (RBM). It also includes a map of Study-Sites by risk indicator.

The Risk Profile page includes the following page-specific sections:

- Subject Recruitment and Discontinuation

- Issue Management

- Essential Documents

- Risk Indicators by Study-Site

- Data Quality

The Risk Profile page includes the following reports:

- Subject Recruitment and Discontinuation Study Risk Gauges (Report CDA-CO-440)

- Study Enrollment Progress Gauge (Report CDA-CO-445)

- Data Quality Study Risk Gauges (Report CDA-DM-500)

- Essential Documents Study Risk Gauges (Report CDA-CO-620)

- Issue Management Study Risk Gauges (Report CDA-CO-840)

- Study-Site Risk Indicator Map (Report CDA-CO-1210)

- Study RACT Score Tile (Report CDA-CO-858)

Protocol Deviations Page

Provides a snapshot of both Study-Site and Subject Protocol Deviations, broken out by Category and by Site.

The Protocol Deviations page includes the following reports:

- Protocol Deviations (Study-Site) by Category (Report CDA-CO-1301)

- Protocol Deviations (Subject) by Category (Report CDA-CO-1302)

- Protocol Deviations (Study-Site) Tile (Report CDA-CO-1303)

- Protocol Deviations (Subject) Tile (Report CDA-CO-1304)

- Protocol Deviations Overview by Study-Site (Report CDA-CO-1305)

Study-Region Overview Dashboard

This dashboard can be accessed by any user. This dashboard includes the following prompts, which are common to all its pages:

- Study

- Therapeutic Area

- Program

- Region

- Study-Region

- Study-Region Manager

- Study Status

- Study-Region Status

Study-Region Overview Dashboard Pages

This dashboard includes the following tabbed pages:

- Overview Page

- Study-Site Milestones Page

- Screening Overview Page

- Recruitment Overview Page

- Retention Overview Page

- Sites to Monitor Page

- Top Investigators Page

- Non Performing Investigators Page

- Site Performance Page

- Monitoring Reports and Follow Up Items Page

- Study-Region Team Page

- Region Document List Page

- Site Document Metrics Page

- Map of Study-Sites Page

Overview Page

Displays report links with the following attributes:

- Section Title - Study-Region Performance Reports

- Show Section Header - True

- Show Section Title - True

- Collapsible - False

The Overview page includes the following reports:

- Study-Region Information (Report CDA-CO-1113)

- Study Region Milestones with Indicators (Single Study-Region) - Data Management View (Report CDA-CO-1116A)

- Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View (Report CDA-CO-1116B)

- Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View (Report CDA-CO-1116C)

- Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View (Report CDA-CO-1116D)

- Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View (Report CDA-CO-1116E)

- Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)

- Subject Recruitment (Study Region) (Report CDA-CO-1114)

- Subject Retention (Study Region) (Report CDA-CO-1115)

- Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)

- Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

Study-Site Milestones Page

The Study-Site Milestones page includes the following reports:

- Study-Region Information (Report CDA-CO-1113)

- Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

- Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

- Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

- Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

- Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

- Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

- Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

Screening Overview Page

The Screening Overview page includes the following reports:

- Screening Overview (Study-Region Level) (Report CDA-CO-434)

- Screening vs. Enrollment by Region (Report CDA-CO-400)

- Screen Failure Reason by Site (Report CDA-CO-300)

- Screen Failure Reason (Report CDA-CO-425)

Recruitment Overview Page

The Recruitment Overview page includes the following page-specific prompt:

- Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The Recruitment Overview page includes the following reports:

- Subject Recruitment (Study Region) (Report CDA-CO-1114)

- Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)

- Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

Retention Overview Page

The Retention Overview page includes the following page-specific prompt:

- Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The Retention Overview page includes the following reports:

- Subject Retention (Study Region) (Report CDA-CO-1115)

- Withdrawn Reason (Report CDA-CO-505)

- Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

- Withdrawn Reason Overview (Report CDA-CO-508)

Sites to Monitor Page

The Sites to Monitor page includes the following reports:

- Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

- Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

- Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

- Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

- Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

- Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

- Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

Top Investigators Page

The Top Investigators page includes the following page-specific prompt:

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

- Top Investigators, Total Enrollment (Report CDA-CO-701)

Non Performing Investigators Page

The Non Performing Investigators page includes the following reports:

- Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

- Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

Site Performance Page

The Site Performance page includes the following reports:

- Site Recruitment Performance - Single Study (Report CDA-CO-416)

- Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

Monitoring Reports and Follow Up Items Page

The Monitoring Reports and Follow Up Items page includes the following page-specific prompts:

- Site Visit Type: Lists types of site visits.

- Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

- Follow Up Item Type: Lists types of follow up item.

The Monitoring Reports and Follow Up Items page includes the following report:

- Site Visit Duration - Study-Region (Report CDA-CO-829)

- Site Visit Duration - Study (Report CDA-CO-808)

- Outstanding Monitoring Reports (Study-Region View) (Report CDA-CO-830)

- Outstanding Monitoring Report Approvals (Study-Region) (Report CDA-CO-831)

- Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)

Study-Region Team Page

The Study-Region Team page includes the following page-specific prompts:

- Active: Lists active status for team members.

- Role: Lists roles for team members.

- Start Date: Supplemental prompt for those reports that include charts displaying data over a period of time.

- End Date: Supplemental prompt for those reports that include charts displaying data over a period of time.

The Study-Region Team page includes the following report:

- Study-Region Team Member List (Report CDA-CO-1107)

Region Document List Page

The Region Document List page includes the following page-specific prompts:

- Activity Type: Lists the Activity Types for documents.

- Document Name: Lists the Document Names.

- Document Sent Date Between: Date range for Document Sent Date.

- Document Received Date Between: Date range for Document Received Date.

- Document Expiration Date Between: Date range for Document Expiration Date.

The Region Document List page includes the following report:

- Documents List (Study Region) (Report CDA-CO-610)

Site Document Metrics Page

The Site Document Metrics page includes the following reports:

- Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

- Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

- Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

Map of Study-Sites Page

The Map of Study-Sites page includes the following report:

- High Level Study-Site Map (Report CDA-CO-1202)

Study-Site Overview Dashboard

This dashboard can be accessed by any user. It provides reports related to site status and performance, subject recruitment and retention within the study-site, site monitoring, and document tracking.

This dashboard includes the following prompts, which are common to all its pages:

- Program: Lists the name of the Programs that owns the Study.

- Study: Lists Studies within a Program.

- Study Region: Lists Regions within a Study.

- Study-Site ID#: Lists Study-Sites within a Study.

- Principal Investigator: Lists Principal Investigator for a Study-Site.

- Study-Site Status: Lists Study Status for a Study.

Study-Site Overview Dashboard Pages

This dashboard includes the following tabbed pages:

- Study-Site Overview Page

- Screening & Recruitment Overview Page

- Retention Overview Page

- Monitoring Metrics Page

- Study-Site Team Page

- Site Document List Page

- Site Document Metrics Page

- Visit Reports & Follow Up Items Page

- Risk Profile Page

- Protocol Deviations Page

Study-Site Overview Page

Displays reports that contain identifying information for a study-site as well has high level overviews of milestones and subject recruitment and retention.

The Study-Site Overview page includes the following page-specific prompts:

- Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

The Study-Site Overview page includes the following reports:

- Study-Site Information (Report CDA-CO-206)

- Study-Site Subject Recruitment Narrative (Report CDA-CO-405)

- Study-Site Subject Retention (Report CDA-CO-500)

- Study-Site Milestones with Indicators (Single Study-Site) - Data Management View (Report CDA-CO-203A)

- Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)

- Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View (Report CDA-CO-203C)

- Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View (Report CDA-CO-203D)

- Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View (Report CDA-CO-203E)

- Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View (Report CDA-CO-203F)

- Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)

- Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

- Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

Screening & Recruitment Overview Page

Displays reports on a study-site's progress toward screening and enrollment, including screen failure reason analysis and screening or recruitment over time.

The Screening & Recruitment Overview page includes the following page-specific prompt:

- Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

The Screening & Recruitment Overview page includes the following reports:

- Screening Overview (Study-Site Level) (Report CDA-CO-415)

- Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

- Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)

- Screen Failure Reason (Report CDA-CO-420)

Retention Overview Page

Displays reports on a study-site's retention pattern, including withdrawn reason analysis and retention vs. enrollment over time.

The Retention Overview page includes the following page-specific prompts:

- Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Retention Overview page includes the following reports:

- Subject Retention (Study-Site Level) (Report CDA-CO-502)

- Subject Retention Over Time (Study Level) (Report CDA-CO-501)

- Withdrawn Reason (Report CDA-CO-505)

- Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

Monitoring Metrics Page

Displays reports on site visit length trends, subject enrollment over time, and distribution of follow up items by type.

The Monitoring Metrics page includes the following page-specific prompts:

- Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

- Site Visit Type: Lists types of site visits.

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Monitoring Metrics page includes the following reports:

- Site Visit Duration - Study Site (Report CDA-CO-800)

- Site Visit Duration - Study (Report CDA-CO-808)

- # Follow Up Items by Type for Study-Site (Report CDA-CO-801)

- Median # Follow Up Items per Site for Study (Report CDA-CO-802)

Study-Site Team Page

Displays a report that lists team members assigned to the study-site.

The Study-Site Team page includes the following page-specific prompts:

- Role: Lists roles for team members.

- Team Member Active: Select the check box for whether or not team member is active.

- Start Date Between: Supplemental prompt for those reports that include charts displaying data over a period of time.

- End Date Between: Supplemental prompt for those reports that include charts displaying data over a period of time.

The Study-Site Team page includes the following report:

- Study-Site Team Member List (Report CDA-CO-201)

Site Document List Page

Displays a report that lists document tracking information for site documents.

The Site Document List page includes the following page-specific prompts:

- Activity Type: Lists the Activity Types for documents.

- Document Name: Lists the Document Names.

- Document Sent Date Between: Date range for Document Sent Date.

- Document Received Date Between: Date range for Document Received Date.

- Document Expiration Date Between: Date range for Document Expiration Date

The Site Document List page includes the following report:

- Documents List (Study-Site) (Report CDA-CO-603)

Site Document Metrics Page

Displays reports on cycle times for site document collection.

The Site Document Metrics page includes the following page-specific prompt:

- Activity Type: Lists the Activity Types for documents.

- Document Name: Lists the Document Names.

- Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Site Document Metrics page includes the following reports:

- Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

- Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

- Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

Visit Reports & Follow Up Items Page

Displays reports that contain identifying information for a study as well has high level overviews of milestones and subject recruitment and retention.

The Visit Reports & Follow Up Items page includes the following page-specific prompts:

- Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

- Site Visit Type: Lists types of site visits.

The Visit Reports & Follow Up Items page includes the following reports:

- Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)

- Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)

- Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)

Risk Profile Page

Provides a snapshot of multiple study-site level risk indictors used in Risk Based Monitoring (RBM).

The Risk Profile page includes the following page-specific sections:

- Subject Recruitment and Discontinuation

- Issue Management

- Essential Documents

- Data Quality

The Risk Profile page includes the following reports:

- Subject Recruitment and Discontinuation Study-Site Risk Gauges (Report CDA-CO-450)

- Study-Site Enrollment Progress Gauge (Report CDA-CO-455)

- Data Quality Study-Site Risk Gauges (Report CDA-DM-505)

- Essential Documents Study-Site Risk Gauges (Report CDA-CO-625)

- Issue Management Study-Site Risk Gauges (Report CDA-CO-845)

- Study-Site Missed Dose Tile (Report CDA-CO-220)

- Study-Site RACT Score Tile (Report CDA-CO-859)

Protocol Deviations Page

Provides a snapshot of both Study-Site and Subject Protocol Deviations, broken out by Category.

The Protocol Deviations page includes the following reports:

- Protocol Deviations (Study-Site) by Category (Report CDA-CO-1301)

- Protocol Deviations (Subject) by Category (Report CDA-CO-1302)

- Protocol Deviations (Study-Site) Tile (Report CDA-CO-1303)

- Protocol Deviations (Subject) Tile (Report CDA-CO-1304)

Index Dashboard

This dashboard can be accessed by any user. It provides users with an at a glance listing of all dashboards and analyses and allows users to navigate directly to specific dashboard pages or analyses.

Index Dashboard Pages

This dashboard includes the following tabbed pages:

- Dashboard & Dashboard Page Index Page

- Dashboard Page & Analysis Index Page

Dashboard & Dashboard Page Index Page

Displays a listing of all dashboards and dashboard pages.

Dashboard Page & Analysis Index Page

Displays a listing of all dashboard pages and their analyses including analyses that do not appear directly on dashboard pages but can only be accessed by navigating from other analyses.

Oracle Health Sciences Clinical Development Analytics Analyses

Note:
If InForm is your source system, you must read discrepancy, discrepancies, soft locked, and hard locked as query, queries, frozen, and locked respectively in the analyses.

OHSCDA includes the following analyses:

- # Follow Up Items by Type (Multiple Study-Sites) (Report CDA-CO-810)

- # Follow Up Items by Type for Study-Site (Report CDA-CO-801)

- Approval & Verification Rates - Worst Performers (Report CDA-DM-350)

- Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-825)

- Average Days from Complete to Initially Approved (Report CDA-DM-325)

- Average Days from Complete to Initially Verified (Report CDA-DM-330)

- Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

- Average Days Discrepancy (Query) Open (Report CDA-DM-205)

- Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

- Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-823)

- Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

- Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

- Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

- Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

- Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

- Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

- Data Quality Study Risk Gauges (Report CDA-DM-500)

- Data Quality Study-Site Risk Gauges (Report CDA-DM-505)

- Detail Study-Site Map (Report CDA-CO-1201)

- Detailed Study Milestones Report (Report CDA-CO-102)

- Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

- Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

- Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

- Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

- Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

- Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

- Documents List (Multiple Study-Sites) (Report CDA-CO-601)

- Documents List (Study Region) (Report CDA-CO-610)

- Documents List (Study-Site) (Report CDA-CO-603)

- Enrollment Overview By Site (Report CDA-CO-426)

- Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

- Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)

- Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)

- Essential Documents Study Risk Gauges (Report CDA-CO-620)

- Essential Documents Study-Site Risk Gauges (Report CDA-CO-625)

- Executive Study-Site Map (Report CDA-CO-1203)

- High Level Study-Site Map (Report CDA-CO-1202)

- Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

- Investigator Contact and Studies List (Report CDA-CO-202)

- Issue Management Study Risk Gauges (Report CDA-CO-840)

- Issue Management Study-Site Risk Gauges (Report CDA-CO-845)

- Key Cycle Times for Paper Studies (Report CDA-DM-400)

- Key EDC Cycle Times (Report CDA-DM-300)

- Key EDC Processing Volumes (Report CDA-DM-305)

- Key Paper Processing Volumes (Report CDA-DM-405)

- Key Performance Indicators Over Time - Monitoring (Region Manager) (Report CDA-CO-1112)

- Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)

- KPI Summary - CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)

- KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

- KPI Summary - LSLV to Database Lock (Executive View) (Report CDA-CO-906)

- KPI Summary - Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)

- KPI Summary - Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)

- KPI Summary - Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)

- KPI Summary - Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

- KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

- KPI Summary - Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)

- List Discrepancy (Query) Details (Report CDA-DM-245)

- List of Follow Up Items (Report CDA-CO-803)

- Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

- Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

- Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)

- Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)

- Median # Follow Up Items per Site for Study (Report CDA-CO-802)

- Monitoring Report Approval - Turnaround Time vs. Goal (Report CDA-CO-813)

- Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

- Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

- Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

- Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

- Number of Studies (Report CDA-CO-1001)

- Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-826)

- Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-828)

- Outstanding Documents List (Report CDA-CO-602)

- Outstanding Follow up Items - Study Overview (Report CDA-CO-805)

- Outstanding Follow up Items (CRA View) (Report CDA-CO-806)

- Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

- Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)

- Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)

- Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)

- Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

- Outstanding Monitoring Report Approvals (Study-Region) (Report CDA-CO-831)

- Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)

- Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

- Outstanding Monitoring Reports (Study-Region View) (Report CDA-CO-830)

- Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)

- Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed (Report CDA-CO-824)

- Outstanding Reports that Missed Target - Site Visit Completed to Visit Report Completed (Report CDA-CO-827)

- Pages Awaiting Entry Completion (Report CDA-DM-450)

- Paper Processing - Longest Cycle Times (Report CDA-DM-415)

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

- Protocol Deviations (Study-Site) by Category (Report CDA-CO-1301)

- Protocol Deviations (Subject) by Category (Report CDA-CO-1302)

- Protocol Deviations (Study-Site) Tile (Report CDA-CO-1303)

- Protocol Deviations (Subject) Tile (Report CDA-CO-1304)

- Protocol Deviations Overview by Study-Site (Report CDA-CO-1305)

- Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)

- Protocol Deviation (Subject) Details (Report CDA-CO-1307)

- Protocol Versions (Report CDA-CO-115)

- Screen Failure Reason (Report CDA-CO-420)

- Screen Failure Reason (Report CDA-CO-425)

- Screen Failure Reason by Site (Report CDA-CO-300)

- Screening Overview (Study Level) (Report CDA-CO-407)

- Screening Overview (Study-Region Level) (Report CDA-CO-434)

- Screening Overview (Study-Site Level) (Report CDA-CO-415)

- Screening vs. Enrollment by Region (Report CDA-CO-400)

- Site Detail (Report CDA-CO-209)

- Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)

- Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)

- Site Recruitment Performance - Single Study (Report CDA-CO-416)

- Site Recruitment Performance (Report CDA-CO-413)

- Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)

- Site Visit Analysis (Report CDA-CO-821)

- Site Visit Duration - Study (Report CDA-CO-808)

- Site Visit Duration - Study Site (Report CDA-CO-800)

- Site Visit Duration - Study-Region (Report CDA-CO-829)

- Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

- Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

- Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

- Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

- Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

- Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

- Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

- Study Documents List (Report CDA-CO-600)

- Study Enrollment Progress Gauge (Report CDA-CO-445)

- Study Information (Report CDA-CO-103)

- Study List - Initiation Details (Report CDA-CO-305)

- Study List - KPI Performance (Report CDA-CO-904)

- Study List - Milestone Performance (Report CDA-CO-109)

- Study List - Recruitment Details (Report CDA-CO-406)

- Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

- Study RACT (Report CDA-CO-852)

- Study RACT by Category (Report CDA-CO-853)

- Study RACT Score Tile (Report CDA-CO-858)

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)

- Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)

- Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)

- Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)

- Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)

- Study Region Milestones with Indicators (Single Study-Region) - Data Management View (Report CDA-CO-1116A)

- Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View (Report CDA-CO-1116B)

- Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View (Report CDA-CO-1116C)

- Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View (Report CDA-CO-1116D)

- Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View (Report CDA-CO-1116E)

- Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)

- Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)

- Study Regions with Red or Yellow Performance Flag - Data Management Detail View (Report CDA-CO-1200A)

- Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)

- Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)

- Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)

- Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)

- Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)

- Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)

- Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)

- Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)

- Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)

- Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)

- Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)

- Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)

- Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

- Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

- Study Team Member List (Report CDA-CO-111)

- Study-Region Information (Report CDA-CO-1113)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

- Study-Region List and Recruitment Counts (Report CDA-CO-404)

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Site Enrollment Progress Gauge (Report CDA-CO-455)

- Study-Site Information (Report CDA-CO-206)

- Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

- Study-Site List with Indicators - Data Management View (Report CDA-CO-207A)

- Study-Site List with Indicators - Monitoring View (Report CDA-CO-207B)

- Study-Site List with Indicators - Recruitment Detail View (Report CDA-CO-207C)

- Study-Site List with Indicators - Retention Detail View (Report CDA-CO-207D)

- Study-Site List with Indicators - Site Start Up Detail View (Report CDA-CO-207E)

- Study-Site List with Indicators - Study Close Detail View (Report CDA-CO-207F)

- Study-Site List with Indicators - Summary View (Report CDA-CO-207G)

- Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

- Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

- Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

- Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

- Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

- Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

- Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

- Study-Site Milestones with Indicators (Single Study-Site) - Data Management View (Report CDA-CO-203A)

- Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)

- Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View (Report CDA-CO-203C)

- Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View (Report CDA-CO-203D)

- Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View (Report CDA-CO-203E)

- Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View (Report CDA-CO-203F)

- Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)

- Study-Site Missed Dose Details (Report CDA-CO-215)

- Study-Site Missed Dose Tile (Report CDA-CO-220)

- Study-Site RACT (Report CDA-CO-856)

- Study-Site RACT by Category (Report CDA-CO-857)

- Study-Site RACT Score Tile (Report CDA-CO-859)

- Study-Site Risk Indicator Map (Report CDA-CO-1210)

- Study-Site Subject Recruitment Narrative (Report CDA-CO-405)

- Study-Site Subject Retention (Report CDA-CO-500)

- Study-Site Team Member List (Report CDA-CO-201)

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

- Subject Enrollment by Region (Report CDA-CO-414)

- Subject Recruitment and Discontinuation Study Risk Gauges (Report CDA-CO-440)

- Subject Recruitment and Discontinuation Study-Site Risk Gauges (Report CDA-CO-450)

- Subject Recruitment (Report CDA-CO-419)

- Subject Recruitment (Study Region) (Report CDA-CO-1114)

- Subject Retention (Report CDA-CO-504)

- Subject Retention (Study Level) (Report CDA-CO-503)

- Subject Retention (Study Region) (Report CDA-CO-1115)

- Subject Retention (Study-Site Level) (Report CDA-CO-502)

- Subject Retention Over Time (Study Level) (Report CDA-CO-501)

- Subject Retention Over Time (Study-Site Level) (Report CDA-CO-510)

- Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

- Subjects Enrolled per Month, Over Time (Report CDA-CO-403)

- Subjects who Failed Screening (Report CDA-CO-428)

- Subjects Withdrawn List (Report CDA-CO-509)

- Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

- Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

- Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Top Investigators, Total Enrollment (Report CDA-CO-701)

- Total Subject Enrollment by Region (Report CDA-CO-410)

- Uninitiated Sites (Report CDA-CO-304)

- Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

- Withdrawn Reason (Report CDA-CO-505)

- Withdrawn Reason Overview (Report CDA-CO-508)

To locate a report, you need to select a dashboard and access a page that contains the report.

# Follow Up Items by Type (Multiple Study-Sites) (Report CDA-CO-810)

Displays the number of follow up items by study-site, stacked by type. This report indicates which types of issues are occurring at a study-site most frequently.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- CRA dashboard, Monitoring Metrics page

- Region Manager dashboard, Monitoring Metrics page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Detailed Study Milestones Report (Report CDA-CO-102)

Reports Referencing This Report

None

Column Descriptions

Table A-1 describes the columns in the # Follow Up Items by Type (multiple Study-Sites) report.

Table A-1 # Follow Up Items by Type (multiple Study-Sites) (Report CDA-CO-810)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study, Site, and Investigator

Study-Site.Study, Site, and Investigator

NA

Count of Follow Up Items

COUNT(- Follow Up Item Metrics.Follow Up Item Created Date)

NA

Follow Up Item Type

Follow Up Item Metrics.Follow Up Item Type

# Follow Up Items by Type for Study-Site (Report CDA-CO-801)

Displays the number of follow up items identified for a study-site, by type. This report indicates which types of issues are occurring at a study-site most frequently.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study-Site Overview dashboard, Monitoring Metrics page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- List of Follow Up Items (Report CDA-CO-803)

Reports Referencing This Report

None

Column Descriptions

Table A-2 describes the columns in the # Follow Up Items by Type for Study-Site report.

Table A-2 # Follow Up Items by Type for Study-Site (Report CDA-CO-801)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Count of Follow Up Items

COUNT(- Follow Up Item Metrics.Follow Up Item Created Date)

NA

Follow Up Item Type

Follow Up Item Metrics.Follow Up Item Type

Approval & Verification Rates - Worst Performers (Report CDA-DM-350)

Identifies the top combined approval and verification rates for EDC studies. This report can be used to compare across sites to see quickly identify which sites and CRAs are taking the longest to approve and verify pages. This indicates the resource shortfalls, process inefficiencies, and potential training needs.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Graph, table (optional)

Location

- Data Manager - EDC dashboard, Home page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-3 describes the columns in the Approval and Verification Rates - Worst Performers report.

Table A-3 Approval and Verification Rates - Worst Performers (Report CDA-DM-350)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study

Study-Site.Study Name

NA

Approved

Received CRFs.% eCRFs Approved / Entry Complete

NA

Verified

Received CRFs.% eCRFs Verified / Entry Complete

Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-825)

Lists all monitoring reports that have been approved, where the number of days from Visit Report Completed to Visit Report Approved exceeds the overall target.

Audience

- Region Manager

Report Type

- Table

Location

None

Dimensions

- Study-Site, Site Visit

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

Column Descriptions

Table A-4 describes the columns in the Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved analysis.

Table A-4 Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-825)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

[Site Visit Report Approved Date]

"Site Visit"."[Site Visit Report Approved Date]"

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

"Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]"

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

"- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]"

Average Days from Complete to Initially Approved (Report CDA-DM-325)

Identifies the average number of days for eCRFs to be approved following entry completion. This report indicates the lag between when an eCRF was entered to when it was initially approved. This measure can be used to compare site performance, and to highlight poor performing sites. When compared across studies, it can be an indicator of study site team inefficiencies.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Graph, table (optional)

Location

- CRA dashboard, Performance page

- Data Manager - EDC dashboard, Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-5 describes the columns in the Average Days from Complete to Initially Approved - Top 25 report.

Table A-5 Average Days from Complete to Initially Approved - Top N (Report CDA-DM-325)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study

Study-Site.Study Name

NA

Avg # Days from eCRF Entry Complete to Initially Approved

Received CRFs.Avg # Days from eCRF Entry Complete to Initially Approved

Average Days from Complete to Initially Verified (Report CDA-DM-330)

Identifies the average number of days for eCRFs to be verified following entry completion. This report indicates the lag between when an eCRF was entered to when it was initially verified. This measure can be used to compare site performance, and can be used to infer the performance of the sites' CRA. When compared across studies, it can be an indicator of study team inefficiencies.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Graph, table (optional)

Location

- CRA dashboard, Performance page

- Data Manager - EDC dashboard, Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-6 describes the columns in the Average Days from Complete to Initially Verified - Top 25 report.

Table A-6 Average Days from Complete to Initially Verified - Top (Report CDA-DM-330)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study

Study-Site.Study Name

NA

Avg # Days from eCRF Complete to Initially Verified

Received CRFs.Avg # Days from eCRF Complete to Initially Verified

Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

Identifies the average number of days discrepancies (queries) are within a grouping of review status. This report indicates which functional teams (or categories) are taking the longest to resolve or progress a discrepancy (query). This information can be used to identify process and resource inefficiencies.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Table Pivot table: rows=Study; columns=Categorized Review Status; cells=Average duration in Review Status, in days

Location

- CRA dashboard, Performance page

- Data Manager - EDC dashboard, Performance page

- Data Manager - Paper dashboard, Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-7 describes the columns in the Average Duration in Categorized Discrepancy (Query) Review Status report.

Table A-7 Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

Discrepancies (Queries)

State

Discrepancies.Discrepancy State

Discrepancies (Queries)

Categorized Review Status

Discrepancy Review Statuses.Discrepancy Review Status

Discrepancies (Queries)

Average duration in Review Status

Discrepancy Review Statuses.Avg # Days Discrepancy Ever in Review Status

Discrepancies (Queries)

# Discrepancies (Queries)

Discrepancies.# Total Discrepancies

Average Days Discrepancy (Query) Open (Report CDA-DM-205)

Identifies distribution of open discrepancies (queries), by the number of days they have been open. This report indicates which sites have the oldest currently open discrepancies (queries).

Audience

- Data Manager

- CRA

Report Type

- Graph, table (optional)

Location

- Data Manager - EDC dashboard, Home page

- Data Manager - EDC dashboard, Study Discrepancies (Queries) page

- Data Manager - Paper dashboard, Home page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- List Discrepancy (Query) Details (Report CDA-DM-245)

Reports Referencing This Report

None

Column Descriptions

Table A-8 describes the columns in the Average Days Discrepancy (Query) Open report.

Table A-8 Average Days Discrepancy (Query) Open (Report CDA-DM-205)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Site Name

Study Site.Site Name

NA

Avg Duration of Currently Open Discrepancies (Queries)

Study-site Metrics.Avg Duration of Currently Open Discrepancies

Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

Identifies the average number of days discrepancies (queries) are open within a review status. This report indicates the average length of time that discrepancies (queries) are remaining at a specific review state. This information can be used to identify process and resource inefficiencies.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Table Pivot table: rows=Study; columns=Review Status; cells=Average duration in Review Status Graph

Location

- Data Manager - EDC dashboard, Performance page

- Data Manager - Paper dashboard, Performance page

Dimensions

- Study-Site

Supplementary Prompts

- Discrepancies.Discrepancy State

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-9 describes the columns in the Average Duration of Open Discrepancies (Queries) in Review Statuses report.

Table A-9 Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study Name

Study-Site.Study Name

NA

Review Status

Discrepancy Review Statuses.Discrepancy Review Status

NA

Average duration in Review Status, in Days

Discrepancy Review Statuses.Avg # Days Open Discrepancy Ever in Review Status

Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-823)

Lists all monitoring reports that have been completed, where the number of days from Site Visit Completed to Visit Report Completed exceeds the overall target.

Audience

- Region Manager

Report Type

- Table

Location

None

Dimensions

- Study-Site, Site Visit

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

Column Descriptions

Table A-10 describes the columns in the Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed analysis.

Table A-10 Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-823)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

"- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed"

Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

Identifies the top CRFs which are producing the most discrepancies (queries). A CRF which is associated with a high number of discrepancies (queries) is often an indication that the validation procedure or the CRF have been poorly designed. Alternatively, it can indicate a misunderstanding on the completion guidelines for the CRF, and can therefore imply a training need for the study site. Early identification of such issues, at an early stage in the study, can dramatically reduce the number of discrepancies (queries) created.

Audience

- Data Manager

Report Type

- Graph, table (optional)

Location

- Data Manager - EDC dashboard, Home page

- Data Manager - EDC dashboard, Study Discrepancies (Queries) page

- Data Manager - Paper dashboard, Home page

Dimensions

- CRF

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- List Discrepancy (Query) Details (Report CDA-DM-245)

Reports Referencing This Report

None

Column Descriptions

Table A-11 describes the columns in the Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank report.

Table A-11 Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

CRF Name

CRF.Name

NA

# Open Discrepancies (Queries)

Discrepancies.# Open Discrepancies

NA

Type

Discrepancies.Type

Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

Identifies how many discrepancies (queries) are open, by review status. This report indicates the number of open discrepancies (queries), within a number of categorized review groups. This information can be used to identify which functional team or area has the most outstanding discrepancies (queries), which could indicate a resource shortage.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Table Pivot table: rows=Study; columns=Categorized Review Status; cells=#Open Discrepancies (Queries) Graph attached to the Pivot table

Location

- Data Manager - EDC dashboard, Discrepancy (Query) Workload page

- Data Manager - Paper dashboard, Discrepancy (Query) Workload page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- List Discrepancy (Query) Details (Report CDA-DM-245)

Reports Referencing This Report

You can navigate to this report from the following reports:

- Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

Column Descriptions

Table A-12 describes the columns in the Counts of Categorized Open Discrepancies (Queries), by Review Status report.

Table A-12 Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

Discrepancies (Queries)

Categorized Review Status

Discrepancy Review Statuses.Discrepancy Review Status

Discrepancies (Queries)

# Open Discrepancies (Queries)

Discrepancies.# Total Discrepancies

Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

Identifies the number of open and closed discrepancies (queries), by review status. This report indicates which review states are creating the largest volumes of discrepancies (queries). This information can be used to identify high discrepancy (query) volumes with a review state which may indicate lack of resource or process inefficiency.

Audience

- Data Manager

- Project Manager

Report Type

- Table Pivot table: rows=Study; columns=Review Status; cells=#Discrepancies (Queries)

Location

- Data Manager - EDC dashboard, Discrepancy (Query) Workload page

- Data Manager - Paper dashboard, Discrepancy (Query) Workload page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-13 describes the columns in the Counts of Discrepancies (Queries), by State and Review Status report.

Table A-13 Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study Name

Discrepancies (Queries)

Review Status

Discrepancy Review Statuses.Discrepancy Review Status

Discrepancies (Queries)

State

Discrepancies.Discrepancy State

Discrepancies (Queries)

# Discrepancies (Queries)

Discrepancies.# Total Discrepancies

Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

Identifies the distribution of discrepancies (queries), by validation procedure. This report indicates which validation procedures are creating the most discrepancies (queries). A procedure which is associated with a high number of discrepancies (queries) is often an indication that the validation procedure has been poorly designed, or that the related actual data exceeds any expected parameters.

Alternatively, it may indicate a misunderstanding on the completion guidelines for the CRF, and may therefore imply a training need for the study site. Early identification of such issues, at an early stage in the study, can dramatically reduce the number of discrepancies (queries) created.

Audience

- Data Manager

Report Type

- Graph, Table (optional)

Location

- Data Manager - EDC dashboard, Home page

- Data Manager - EDC dashboard, Study Discrepancies (Queries) page

- Data Manager - Paper dashboard, Home page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- List Discrepancy (Query) Details (Report CDA-DM-245)

Reports Referencing This Report

None

Column Descriptions

Table A-14 describes the columns in the Counts of Open Multivariate Discrepancies (Queries), by Procedure report.

Table A-14 Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Discrepancies (Queries)

Validation Procedure Name

Discrepancies.Validation Procedure Name

Discrepancies (Queries)

# Open Discrepancies (Queries)

Discrepancies.# Open Discrepancies

Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

Displays planned number of subjects for the study-site compared to enrolled and early terminated. This report indicates how well the study-site is progressing toward retention goals.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study-Site Overview dashboard, Study-Site Overview, Retention Overview page

Dimensions

- All-Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-15 describes the columns in the Cumulative Enrollment and Early Term (Study-Site) report.

Table A-15 Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Subjects Planned for Study-Site

MAX(- Study-site Metrics.# Subjects Planned for Study-Site)

NA

# Enrolled

RSUM(- Study-site Metrics.# Subjects Enrolled)

NA

# Early Terminations

Study-site Metrics.# Early Terminations

Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

Displays planned number of subjects for the study-site compared to actual screened and enrolled. This report indicates how well the study-site is progressing toward recruitment goals.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study-Site Overview dashboard, Study-Site Overview page

- Study-Site Overview dashboard, Screening and Recruitment Overview page

Dimensions

- All-Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-16 describes the columns in the Cumulative Screening and Enrollment Bar (Study-Site) report.

Table A-16 Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Subjects Planned for Study-Site

MAX(- Study-site Metrics.# Subjects Planned for Study-Site)

NA

# Screened

RSUM(- Study-site Metrics.# Screened)

NA

# Enrolled

RSUM(- Study-site Metrics.# Subjects Enrolled)

Data Quality Study Risk Gauges (Report CDA-DM-500)

Displays gauges for data quality risk indicators at the study level.

Audience

- Study Manager

- Region Manager

- Data Manager

- CRA

Report Type

- Gauge

Location

- Study Overview dashboard, Risk Profile page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Data Quality Study-Site Risk Gauges (Report CDA-DM-505)

Displays gauges for data quality risk indicators at the study-site level.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study-Site Overview dashboard, Risk Profile page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Detail Study-Site Map (Report CDA-CO-1201)

Displays study-sites geographically by # Enrolled, # Days Since Last Enrollment for Study-Site, # Subjects Enrolled Since Latest Site Visit and # Days Since Latest Site Visit.

Audience

- CRA

Report Type

- Map

Location

- CRA dashboard, Study-Site Map page

Dimensions

None

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-17 describes the columns in the Detail Study-Site Map analysis.

Table A-17 Detail Study-Site Map (Report CDA-CO-1201)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study-Site ID #

NA

Study-Site

Street Address

NA

Study-Site

City

NA

Study-Site

Country

NA

Study-Site

Latitude

NA

Study-Site

Longitude

NA

Study-Site Metrics

# Enrolled

NA

Study-Site Metrics

# Days Since Last Enrollment for Study-Site

NA

Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

NA

Study-Site Metrics

# Days Since Latest Site Visit

NA

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

Detailed Study Milestones Report (Report CDA-CO-102)

Lists (for a study) key milestone dates and enrollment, enrollment progress, and study-health indicator. This report indicates whether a study requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Manager dashboard, Study Manager Overview page

- Executive Overview dashboard, Study List

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-18 describes the columns in the Detailed Study Milestones Report.

Table A-18 Detailed Study Milestones Report (Report CDA-CO-102)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study

Program

Study.Program

NA

Product

Study.Product

NA

Study

Study.Study

NA

Short Title

Study.Study Short Title

NA

Status

Study.Study Status

NA

Study Manager

Study.Study Manager

NA

Navigate to detail

NA

- Study Original Planned Dates

Planned 1st Site Initiated Date

CONCAT(CONCAT('Planned: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS char)),CONCAT(CONCAT(' LE: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS CHAR)),CONCAT(' Actual: ',CAST("- Study Metrics"."1st Site Initiated Date" AS CHAR))))

- Study Original Planned Dates

Planned 1st Site Initiated Date

CONCAT(CONCAT('Planned: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS char)),CONCAT(CONCAT(' LE: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS CHAR)),CONCAT(' Actual: ',CAST("- Study Metrics"."1st Site Initiated Date" AS CHAR))))

- Study Metrics

1st Site Initiated Date

CONCAT(CONCAT('Planned: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS char)),CONCAT(CONCAT(' LE: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS CHAR)),CONCAT(' Actual: ',CAST("- Study Metrics"."1st Site Initiated Date" AS CHAR))))

- Study Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]"as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]"as char(40)))

- Study Metrics

Latest Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]"as char(40)))

- Study Metrics

[Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]"as char(40)))

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MIN("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."Screen Failure Rate" as char(40)))

- Study Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MIN("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."Screen Failure Rate" as char(40)))

- Study Metrics

% Planned Subjects Enrolled (Study)

CONCAT('Actual:' , cast(MAX("- Study Metrics"."% Planned Subjects Enrolled (Study)") as char(40)))

- Study Metrics

% Planned Subjects Randomized (Study)

CONCAT('Actual:' , cast(MAX("- Study Metrics"."% Planned Subjects Randomized (Study)") as char(40)))

- Study Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MIN("- Study Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."% Subjects Early Terminated for Study" as char(40)))

- Study Metrics

% Subjects Early Terminated for Study

CONCAT('Expected:',cast(MIN("- Study Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."% Subjects Early Terminated for Study" as char(40)))

- Study Metrics

% of Planned Sites Initiated

"- Study Metrics"."% of Planned Sites Initiated"

- Study Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('ActualL(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('ActualL(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

Latest Subject Enrollment Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('ActualL(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('ActualL(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies")

- Discrepancies (Queries)

# Total Discrepancies (Queries)

("- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies")

- Received CRFs

# eCRFs To Be Approved

CONCAT('Actual:',cast("- Received CRFs"."# eCRFs To Be Approved" as char(40)))

- Received CRFs

# eCRFs To be Verified

CONCAT('Actual:',cast("- Received CRFs"."# eCRFs To be Verified" as char(40)))

- Received CRFs

# CRFs Soft- Locked (Frozen)

CONCAT('Actual:',cast("- Received CRFs"."# CRFs Soft- Locked" as char(40)))

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

CONCAT('Actual:',cast(("- Received CRFs"."% CRFs Soft Locked / Entry Complete") as char(40)))

- Received CRFs

# CRFs Hard-Locked (Locked)

CONCAT('Actual:',cast("- Received CRFs"."# CRFs Hard-Locked" as char(40)))

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

CONCAT('Actual:',cast(("- Received CRFs"."% CRFs Hard Locked / Entry Complete") as char(40)))

- Study Metrics

KPI Flag

"- Study Metrics"."KPI Flag"

- Study Metrics

KPI Detail Reason

"- Study Metrics"."KPI Detail Reason"

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."% Sites Recruiting 0 Subjects" as char(40)))

- Study Metrics

% Sites Recruiting 0 Subjects

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."% Sites Recruiting 0 Subjects" as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]",1)) as char(40)))

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]",1)) as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]",1)) as char(40)))

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]",1)) as char(40)))

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]",1) as char(40)))

- Study Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]",1) as char(40)))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)",1)) as char(40)))

- Study Metrics

Median Site Visit Completed to Visit Report Completed (# Days)

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)",1)) as char(40)))

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)",2)) as char(40)))

- Study Metrics

Median Visit Report Completed to Visit Report Approved (# Days)

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)",2)) as char(40)))

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)",2)) as char(40)))

- Study Metrics

Latest Subject Latest Visit to Database Lock (# Days)

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)",2)) as char(40)))

- Study Metrics

Recruitment Flag

"- Study Metrics"."Recruitment Flag"

- Study Metrics

Recruitment Detail Reason

"- Study Metrics"."Recruitment Detail Reason"

- Study Metrics

Milestone Flag

"- Study Metrics"."Milestone Flag"

- Study Metrics

Milestone Detail Reason

"- Study Metrics"."Milestone Detail Reason"

- Study Metrics

Retention Flag

"- Study Metrics"."Retention Flag"

- Study Metrics

Retention Detail Reason

"- Study Metrics"."Retention Detail Reason"

- Study Metrics

# Study-Sites Planned for Study

CONCAT('Planned:',cast(MIN("- Study Metrics"."# Study-Sites Planned for Study") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."# Study-Sites Initiated") as char(40)))

- Study Metrics

# Study-Sites Initiated

CONCAT('Planned:',cast(MIN("- Study Metrics"."# Study-Sites Planned for Study") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."# Study-Sites Initiated") as char(40)))

- Study Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."Database Lock Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."Database Lock Date" as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."Database Lock Date" as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."[Clinical Study Report Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."[Clinical Study Report Date]" as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."[Clinical Study Report Date]" as char(40)))

- Study Key Dates

[Protocol Approved Date]

CONCAT('Actual:' , cast(MAX("- Study Key Dates"."[Protocol Approved Date]") as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

Identifies the rate of discrepancies (queries) per pages entered. This report displays the top studies and associated sites which have the highest numbers of discrepancies (queries) per page. This information can be used to identify poor performance across studies and across sites.

Audience

- Data Manager

Report Type

- Graph, table (optional)

Location

- Data Manager - EDC dashboard, Quality page

- Data Manager - Paper dashboard, Quality page

Dimensions

- Study-Site

Supplementary Prompts

- Top N

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-19 describes the columns in the Discrepancies (Queries) per Pages Entered - Top N report.

Table A-19 Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study

Study-Site.Study Name

NA

Total Discrepancies (Queries) per CRF

Study-site Metrics.Total Discrepancies per CRF

Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

Identifies the rate of discrepancies (queries) per subjects enrolled. This report identifies the top studies and associated sites which have the highest numbers of discrepancies (queries) per enrolled subject. This information can be used to identify poor performance across studies and across sites.

Audience

- Data Manager

Report Type

- Graph, Table (optional)

Location

- Data Manager - EDC dashboard, Quality page

- Data Manager - Paper dashboard, Quality page

Dimensions

- Study-Site

Supplementary Prompts

- Top N

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-20 describes the columns in the Discrepancies (Queries) per Subjects Enrolled report.

Table A-20 Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study Name

Study-Site.Study Name

NA

Total Discrepancies (Queries) per Enrolled Subject

Study-Site Metrics.Total Discrepancies per Enrolled Subject

Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

Identifies how many discrepancies (queries) are open and closed. In addition, the report also shows ratios of the number of discrepancies (queries) per CRF entered. If these ratios vary significantly by site they may indicate a poor performing site with a training need.

Also, comparing these measures across studies can highlight inefficiencies between study teams, although it is important to also note that study variances are often a factor of study complexity and therapeutic area.

Audience

- Data Manager

- CRA

Report Type

- Table

Location

- Data Manager - EDC dashboard, Discrepancy (Query) Workload page

- Data Manager - Paper dashboard, Discrepancy (Query) Workload page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

Reports Referencing This Report

None

Column Descriptions

Table A-21 describes the columns in the Discrepancy (Query) Overview with Ratios report.

Table A-21 Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# CRFs Present

Received CRFs.# CRFs Present

# Discrepancies (Queries)

Open

Discrepancies.# Open Discrepancies

# Discrepancies (Queries)

Closed

Discrepancies.# Closed Discrepancies

# Discrepancies (Queries)

Total

Discrepancies.# Total Discrepancies

Discrepancies (Queries) per Received CRF

Open

Study-site Metrics.Open Discrepancies per CRF

Discrepancies (Queries) per Received CRF

Total

Study-site Metrics.Total Discrepancies per CRF

Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

Displays (by document type) the median days a document has been outstanding. This report indicates how long have documents been outstanding. It also indicates the documents that lag the most.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, table (optional)

Location

- Study Overview dashboard, Site Document Metrics page

- Study-Site Overview dashboard, Site Document Metrics page

- Study-Region Overview dashboard, Study-Site Document Metrics page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-22 describes the columns in the Document Collection Cycle Times - Days Outstanding by Type report.

Table A-22 Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Document Type

Document Metrics.Activity Type

NA

Median # Days Document Outstanding

Document Metrics.Avg # Days Document Outstanding MEDIAN(- Document Metrics.# Days Document Outstanding BY - Document Metrics.Activity Type)

Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

Lists the cycle times for all documents collected for the study. This report indicates the number of days a document has been outstanding, or how long it took to receive from the site.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Site Document Metrics page

- Study-Site Overview dashboard, Site Document Metrics page

- Study-Region Overview dashboard, Study-Site Document Metrics page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-23 describes the columns in the Document Collection Cycle Times (Study-Site) report.

Table A-23 Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Activity Type

Document Metrics.Activity Type

NA

Study Region

Study-Site.Study Region

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Document Name

Document Metrics.Document Name

NA

Document Sent Date

Document Metrics.Document Sent Date

NA

Document Received Date

Document Metrics.Document Received Date

NA

# Days from Document Sent to Document Received

Document Metrics.# Days from Document Sent to Document Received

NA

# Days Document Outstanding

Document Metrics.# Days Document Outstanding

Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

Displays (by document type) the average turn around time from document sent to document received. This report indicates if essential documents are being gathered on time, and how long does it typically take to receive a document. It also indicates the documents that lag the most.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, table (optional)

Location

- Study Overview dashboard, Site Document Metrics page

- Study-Site Overview dashboard, Site Document Metrics page

- Study-Region Overview dashboard, Study-Site Document Metrics page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-24 describes the columns in the Document Collection Cycle Times -Turn Around Time by Type report.

Table A-24 Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Document Type

Document Metrics.Activity Type

NA

Median # Days from Document Sent to Document Received

Document Metrics.Avg # Days from Document Sent to Document Received MEDIAN(- Document Metrics.# Days from Document Sent to Document Received BY - Document Metrics.Activity Type)

Documents List (Multiple Study-Sites) (Report CDA-CO-601)

Lists all site documents collected, including document status, sent date, received date, and comments. This report indicates which study-site-level documents have been collected or are missing.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Study-Site Document List page

Dimensions

- None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-25 describes the columns in the Documents List (Multiple Study-Sites) report.

Table A-25 Documents List (Multiple Study-Sites) (Report CDA-CO-601)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Activity Type

Document Metrics.Activity Type

NA

Document Name

Document Metrics.Document Name

NA

Document Sent Date

Document Metrics.Document Sent Date

NA

Days Since Doc Sent

TIMESTAMPDIFF(SQL_TSI_DAY, - Document Metrics.Document Sent Date,NOW())

NA

Document Received Date

Document Metrics.Document Received Date

NA

Document Expiration Date

Document Metrics.Document Expiration Date

NA

Indicator

TBD

NA

Document Comments

Document Metrics.Document Comments

Documents List (Study Region) (Report CDA-CO-610)

Lists all study-region documents collected, including document status, sent date, received date, and comments. This report indicates which study-level documents have been collected or are missing.

Audience

- Region Manager

Report Type

- Table

Location

- Study-Region Overview dashboard, Region Document List page

Dimensions

- NA

Supplementary Prompts

- Document Page Prompt Filter (existing Filter from the previous release

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-26 describes the columns in the Documents List (Study Region) analysis.

Table A-26 Documents List (Study Region) (Report CDA-CO-610)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Document Metrics

Activity Type

"- Document Metrics"."Activity Type"

- Document Metrics

Document Name

"- Document Metrics"."Document Name"

- Document Metrics

Document Sent Date

"- Document Metrics"."Document Sent Date"

- Document Metrics

Document Received Date

"- Document Metrics"."Document Received Date"

- Document Metrics

Document Expiration Date

"- Document Metrics"."Document Expiration Date"

- Document Metrics

Document Comments

"- Document Metrics"."Document Comments"

- Document Metrics

Document Expiration Date Indicator

CASE WHEN "- Document Metrics"."Document Expiration Date" < VALUEOF(CURRENT_DAY) THEN '1-Red' WHEN "- Document Metrics"."Document Expiration Date" > VALUEOF(CURRENT_DAY) AND "- Document Metrics"."Document Expiration Date" <= TIMESTAMPADD(SQL_TSI_DAY, 30,VALUEOF(CURRENT_DAY) ) THEN '2-Yellow' WHEN "- Document Metrics"."Document Expiration Date" > TIMESTAMPADD(SQL_TSI_DAY, 30,VALUEOF(CURRENT_DAY) ) THEN '3-Green' END

Documents List (Study-Site) (Report CDA-CO-603)

Lists all site documents collected, including document status, sent date, received date, and comments. This report indicates which study-site-level documents have been collected or are missing.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Document List page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-27 describes the columns in the Documents List (Study-Site) report.

Table A-27 Documents List (Study-Site) (Report CDA-CO-603)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Activity Type

Document Metrics.Activity Type

NA

Document Name

Document Metrics.Document Name

NA

Document Sent Date

Document Metrics.Document Sent Date

NA

Days Since Doc Sent

TIMESTAMPDIFF(SQL_TSI_DAY, - Document Metrics.Document Sent Date,NOW())

NA

Document Received Date

Document Metrics.Document Received Date

NA

Document Expiration Date

Document Metrics.Document Expiration Date

NA

Indicator

TBD

NA

Document Comments

Document Metrics.Document Comments

Enrollment Overview By Site (Report CDA-CO-426)

Lists (by program, study, and region) all sites and the number of planned and actual subjects enrolled. This report indicates how well are we progressing against planned enrollment. It also shows the progress of subject recruitment, and how many subjects have been screened, enrolled, and randomized. This report also indicates the progress of each region towards enrollment.

Audience

- Study Manager

- CRA

Report Type

- Pivot Table

Location

- Study Overview dashboard, Study Region Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Site Detail (Report CDA-CO-209)

Reports Referencing This Report

None

Column Descriptions

Table A-28 describes the columns in the Enrollment Overview By Site report.

Table A-28 Enrollment Overview By Site (Report CDA-CO-426)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

Study Region Status

Region.Region Status

NA

Study-Site ID#

Study-Site.Study-Site ID#

NA

Site Name

Study-Site.Site Name

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Study-Site Status

Study-Site.Study-Site Status

NA

CRA

Study-Site.CRA

NA

# Subjects Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

Shows cumulative actual enrollment over time, compared to static plan (50%, 75%, 90% and 100%) for a study. This report indicates the progress of subject recruitment. It also indicates how well we are progressing against planned enrollment.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Study Overview, Recruitment Overview page

Dimensions

- Study-Site

- All-Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-29 describes the columns in the Enrollment Progress Over Time (Study Level) report.

Table A-29 Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Year and Month

- All Purpose Date.Year and Month

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

1

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END))

NA

0.9

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .9)

NA

0.75

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .75)

NA

0.5

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .5)

NA

# Subjects Enrolled (Cumulative)

RSUM(- Study-site Metrics.# Subjects Enrolled)

Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)

Shows cumulative actual enrollment over time, compared to static plan (50%, 75%, 90% and 100%) for a study-site. This report indicates the progress of subject recruitment. It also indicates how well we are progressing against planned enrollment.

Audience

- Region Manager, Study Manager, Executive Manager, Program Manager

Report Type

- View Selector (Chart, Table)

Location

- Study-Region Overview dashboard, Recruitment Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-30 describes the columns in the Enrollment Progress Over Time (Study-Region Level) analysis.

Table A-30 Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Month

"- All Purpose Date"."Year and Month"

Study-Region

Study

"Study-Region"."Study"

Study-Region

Region Name

"Study-Region"."Region Name"

- Study-Site Metrics

# Enrolled

IFNULL(RSUM("- Study-Site Metrics"."# Enrolled"), 0) + @{pv_subj_enrolled_stdy_reg}

Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)

Shows cumulative actual enrollment over time, compared to static plan (50%, 75%, 90% and 100%) for a study-site. This report indicates the progress of subject recruitment. It also indicates how well we are progressing against planned enrollment.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study-Site Overview dashboard, Screening and Recruitment Overview page

Dimensions

- Study-Site All-Purpose Date

Supplementary Prompts

- Page Specific Year and Month Between prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-31 describes the columns in the Enrollment Progress Over Time (Study-Site Level) report.

Table A-31 Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

# Subjects Enrolled (Cumulative)

RSUM(- Study-site Metrics.# Subjects Enrolled)

NA

Year and Month

All Purpose Date.Year and Month

Essential Documents Study Risk Gauges (Report CDA-CO-620)

Displays gauges for essential document risk indicators at the study level.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study Overview dashboard, Risk Profile page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Essential Documents Study-Site Risk Gauges (Report CDA-CO-625)

Displays gauges for essential document risk indicators at the study-site level.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study-Site Overview dashboard, Risk Profile page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Executive Study-Site Map (Report CDA-CO-1203)

Displays the following metrics by country: # Sites Recruiting 0 Subjects, # Sites Recruiting 1 or More Subjects, # Sites Recruiting at Least 90% of Planned Subjects, Median Initial IRB/EC Approval to Site Initiated (# Days), Median Site Initiated to 1st Subject Enrolled (# Days) and # Study-Sites Initiated.

Audience

- Executive

Report Type

- Map

Location

- Executive dashboard, Map of Study-Sites, Region manager dashboard, Study-Region Overview dashboard, Overview page

Dimensions

None

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-32 describes the columns in the Executive Study-Site Map analysis.

Table A-32 Executive Study-Site Map (Report CDA-CO-1203)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Country

NA

Study-Region Metrics

# Sites Recruiting 0 Subjects

NA

Study-Region Metrics

# Sites Recruiting 1 or More Subjects

NA

Study-Region Metrics

# Sites Recruiting at Least 90% of Planned Subjects

NA

Study-Region Metrics

Median Initial IRB/EC Approval to Site Initiated (# Days)

NA

Study-Region Metrics

Median Site Initiated to 1st Subject Enrolled (# Days)

NA

Study-Region Metrics

# Study-Sites Initiated

NA

High Level Study-Site Map (Report CDA-CO-1202)

Displays study-sites geographically by # Enrolled, # Days Since Last Enrollment for Study-Site, # Subjects Enrolled Since Latest Site Visit and # Days Since Latest Site Visit. Also displays the following metrics by country: # Enrolled, # Current Active Subjects and # Early Terminations.

Audience

- Region Manager, Study Manager, CRA, Executive

Report Type

- Map

Location

- Executive dashboard, Study-Site Map, Region manager dashboard, Map of Study-Sites Study Overview dashboard, Map of Study-Sites Study Manager dashboard, Map of Study-Sites page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-33 describes the columns in the High Level Study-Site Map analysis.

Table A-33 High Level Study-Site Map (Report CDA-CO-1202)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study-Site ID #

NA

Study-Site

Street Address

NA

Study-Site

City

NA

Study-Site

Country

NA

Study-Site Metrics

# Enrolled

NA

Study-Site Metrics

# Current Active Subjects

NA

Study-Site Metrics

# Early Terminations

NA

Study-Site Metrics

# Days Since Last Enrollment for Study-Site

NA

Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

NA

Study-Site Metrics

# Days Since Latest Site Visit

NA

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

Lists initiated study-sites and their progress toward recruitment goals, as well as details including days since initiation and days since latest enrollment.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Initiating and Recruiting Study-Sites page

- Study-Region Overview dashboard, Recruitment Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-34 describes the columns in the Initiated Study-Sites with Recruitment Counts report.

Table A-34 Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

% to Plan

Enrollment

Study-site Metrics.% Enrolled to Total Planned at Study-Site

% to Plan

Randomization

Study-site Metrics.% Randomized vs. Planned - Study-Site

# Subjects

Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

# Subjects

# Screened

Study-site Metrics.# Screened

# Subjects

# Screen Failure

Study-site Metrics.# Screen Failure

# Subjects

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

# Subjects

# Randomized

Study-site Metrics.# Randomized

Site Initiation

Site Initiated Date

Study-Site.Site Initiated Date

Site Initiation

# Days Since Initiation

Study-site Metrics.# Days Since Initiation

Latest Subject Enrolled

Date

Study-site Metrics.Latest Subject Enrolled Date

Latest Subject Enrolled

# Days Since

Study-site Metrics.# Days Since Last Enrollment for Study-site

NA

Navigate to detail

NA

Investigator Contact and Studies List (Report CDA-CO-202)

Lists contact information for an investigator, as well as a list of the studies they have participated in. This report provides contact information on principal investigators.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

None

Dimensions

- Study-Site

- Principal Investigator

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

- Top Investigators, Total Enrollment (Report CDA-CO-701)

Column Descriptions

Table A-35 describes the columns in the Investigator Contact and Studies List report.

Table A-35 Investigator Contact and Studies List (Report CDA-CO-202)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Investigator Email Address

Investigator.Investigator Email Address

NA

Investigator Fax/Phone #

Investigator.Investigator Fax/Phone #

NA

Investigator Street Address

Investigator.Investigator Street Address

NA

Investigator Street Address 2

Investigator.Investigator Street Address 2

NA

Investigator Street Address 3

Investigator.Investigator Street Address 3

NA

Investigator City

Investigator.Investigator City

NA

Investigator State

Investigator.Investigator State

NA

Investigator Postal Code

Investigator.Investigator Postal Code

NA

Investigator Country

Investigator.Investigator Country

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Site Name

Study-Site.Site Name

NA

Study-Site Status

Study-Site.Study-Site Status

NA

# Subjects Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

% of Planned Site Enrollment Completed

Study-site Metrics.% of Planned Site Enrollment Completed

Issue Management Study Risk Gauges (Report CDA-CO-840)

Displays gauges for issue management risk indicators at the study level.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study Overview dashboard, Risk Profile page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Issue Management Study-Site Risk Gauges (Report CDA-CO-845)

Displays gauges for issue management risk indicators at the study-site level.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study-Site Overview dashboard, Risk Profile page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Key Cycle Times for Paper Studies (Report CDA-DM-400)

Identifies key cycle times for paper studies, and can be used to compare studies against each other. This report indicates key lags in process steps and potential inefficiencies.

Audience

- Data Manager

- Project Manager

Report Type

- Table

Location

- Data Manager - Paper dashboard, Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-36 describes the columns in the Key Cycle Times for Paper Studies report.

Table A-36 Key Cycle Times for Paper Studies (Report CDA-DM-400)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

# pCRFs

Present

Received CRFs.# pCRFs Present

# pCRFs

Entry Complete

Received CRFs.# pCRFs Entry Complete

Average Days

Visit to First Entry

Received CRFs.Avg # Days from pCRF Visit to First Entry

Average Days

First Entry to Second Entry Complete

Received CRFs.Avg # Days from pCRF First Entry to Second Entry Complete

Average Days

Visit to Entry Complete

Received CRFs.Avg # Days from pCRF Visit to Entry Complete

Average Days

Entry Complete to Soft Locked (Frozen)

Received CRFs.Avg # Days from pCRF Entry Complete to Soft Locked

Key EDC Cycle Times (Report CDA-DM-300)

Identifies the key cycle times for EDC studies, and can be used to compare sites within study, and to compare studies against each other. This report indicates key lags in process steps, and potential inefficiencies.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Table

Location

- CRA dashboard, Performance page

- Data Manager - EDC dashboard, Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-37 describes the columns in the Key EDC Cycle Times report.

Table A-37 Key EDC Cycle Times (Report CDA-DM-300)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

Study-Site

Study Name

Study-Site.Study Name

NA

#Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Entry Complete

Received CRFs.# eCRFs Entry Complete

Average Days From Visit To

Entry Complete

Received CRFs.Avg # Days from eCRF Visit to eCRF Complete

Average Days From Entry Completion To

Initially Approved

Received CRFs.Avg # Days from eCRF Entry Complete to Initially Approved

Average Days From Entry Completion To

Initially Verified

Received CRFs.Avg # Days from eCRF Complete to Initially Verified

Average Days From Entry Completion To

Soft Locked (Frozen)

Received CRFs.Avg # Days from eCRF Complete to Soft Locked

Key EDC Processing Volumes (Report CDA-DM-305)

Identifies the key processing volumes for EDC studies. This report displays page processing volumes for EDC studies. It also displays eCRFs processed and to be processed.

Ratios of approved and verified data can also be used to show progress through the study. This report can be used to understand resource requirements based on work volumes.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Table

Location

- CRA dashboard, eCRF Workload page

- Data Manager - EDC dashboard, eCRF Workload page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- List Discrepancy (Query) Details (Report CDA-DM-245)

- Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

Reports Referencing This Report

None

Column Descriptions

Table A-38 describes the columns in the Key EDC Processing Volumes report.

Table A-38 Key EDC Processing Volumes (Report CDA-DM-305)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

NA

#Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Open Discrepancies (Queries)

Discrepancies.# Open Discrepancies

# eCRFs

Entry Complete

Received CRFs.# eCRFs Entry Complete

# eCRFs

Not Verified

Received CRFs.# eCRFs Not Verified

# eCRFs

Verified

Received CRFs.# eCRFs Verified

# eCRFs

Not Approved

Received CRFs.# eCRFs To Be Approved

# eCRFs

Approved

Received CRFs.# eCRFs Approved

# eCRFs

Soft Locked (Frozen)

Received CRFs.# eCRFs Soft Locked

# eCRFs

Hard Locked (Locked)

Received CRFs.# eCRFs Hard Locked

% of Entry-Complete eCRFs

Approved

Received CRFs.% eCRFs Approved / Entry Complete

% of Entry-Complete eCRFs

Verified Foot 1  Conditional Formatting Threshold: Yellow - between 30 and 50 Conditional Formatting Threshold: Red - less than or equal to 30

Received CRFs.% eCRFs Verified / Entry Complete

% of Entry-Complete eCRFs

Soft Locked (Frozen)

Received CRFs.% eCRFs Soft Locked / Entry Complete

% of Entry-Complete eCRFs

Hard Locked (Locked)

Received CRFs.% eCRFs Hard Locked / Entry Complete

NA

Navigate to Detail

NA

Key Paper Processing Volumes (Report CDA-DM-405)

Identifies key page processing volumes for paper studies. This report displays pages processed and to be processed. This information can be used to understand resource requirements based on work volumes.

Audience

- Data Manager

- Project Manager

Report Type

- Table

Location

- Data Manager - Paper dashboard, Page Workload page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

Reports Referencing This Report

None

Column Descriptions

Table A-39 describes the columns in the Key Paper Processing Volumes report.

Table A-39 Key Paper Processing Volumes (Report CDA-DM-405)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study Name

NA

#Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Open Discrepancies (Queries)

Discrepancies.# Open Discrepancies Note: This is all discrepancies, not just those arising from CRFs.

# CRFs

Present

Received CRFs.# pCRFs Present

# CRFs

Awaiting First Entry Completion

Received CRFs.# pCRFs Awaiting Pass 1 Entry Completion

# CRFs

Awaiting Second Entry Completion

Received CRFs.# pCRFs Awaiting Pass 2 Entry Completion

# CRFs

Entry Complete

Received CRFs.# pCRFs Entry Complete

# CRFs

Blank

Received CRFs.# pCRFs Blank

# CRFs

Soft Locked (Frozen)

Received CRFs.# pCRFs Soft Locked

# CRFs

Hard Locked (Locked)

Received CRFs.# pCRFs Hard Locked

% of Entry-Complete eCRFs

Soft Locked (Frozen)

Received CRFs.% pCRFs Soft Locked / Entry Complete

% of Entry-Complete eCRFs

Hard Locked (Locked)

Received CRFs.% pCRFs Hard Locked / Entry Complete

NA

Navigate to Detail

NA

Key Performance Indicators Over Time - Monitoring (Region Manager) (Report CDA-CO-1112)

Line-bar graph that shows the region median for the following monitoring measures compared to the number of completed site visits, by month:

- # Days from Site Visit Completed to Visit Report Completed

- # Days from Monitoring Report Completed to Monitoring Report Approved

- # Days from Follow Up Item Identified to Follow Up Item Resolved

Audience

- Region Manager

Report Type

- View Selector (Chart, Table)

Location

- Region Manager dashboard, Monitoring Metrics page

Dimensions

- Visit Report Completed Date

Supplementary Prompts

- Site Visit Start Date page prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-40 describes the columns in the Key Performance Indicators Over Time: Monitoring (Region Manager) analysis.

Table A-40 Key Performance Indicators Over Time: Monitoring (Region Manager) (Report CDA-CO-1112)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Visit Report Completed Date

Year and Month

"- Visit Report Completed Date"."Year and Month"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

MEDIAN("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]")

- Follow Up Item Metrics

# Days from Site Visit Completed to Follow Up Item Completed

MEDIAN("- Follow Up Item Metrics"."# Days from Site Visit Completed to Follow Up Item Completed")

Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)

Line graph that shows the following measures by quarter at the overall level:

- Median Critical Document Package Complete to Site Initiated

- Median LSLV to DB Lock

- Median Protocol Approved to 1st Site Initiated

- Median Protocol Approved to 1st Subject Enrolled

- Median Site Visit Completed to Visit Report Completed

- Median Visit Report Completed to Visit Report Approved

This report shows the overall time trend for KPIs at the executive level.

Audience

- Executive

Report Type

- Line Graph (View selector)

Location

- Executive dashboard, Overview page

Dimensions

- All Purpose Date

Supplementary Prompts

- Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-41 describes the columns in the Key Performance Indicators Over Time (Executive View) analysis.

Table A-41 Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- All Purpose Date

Year

"- All Purpose Date"."Year"

- Study-Site Metrics

Critical Document Package Complete to Site Initiated (# Days)

MEDIAN("- Study-Site Metrics"."Critical Document Package Complete to Site Initiated (# Days)")

- Study Metrics

[Last Subject Last Visit to Database Lock (# Days)]

MEDIAN("- Study Metrics"."[Last Subject Last Visit to Database Lock (# Days)]")

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

MEDIAN("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]")

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

MEDIAN("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]")

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

MEDIAN("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]")

KPI Summary - CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)

Line and line-bar graphs that show the overall median compared to the overall target for Critical Document Package Complete to Site Initiated (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

- Executive

Report Type

- Multiple Graphs (View selector)

Location

- Executive dashboard, KPI Summary page

Dimensions

- All Purpose Date

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-42 describes the columns in the KPI Summary: CDP Complete to Site Initiated (Executive View) analysis.

Table A-42 KPI Summary: CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Quarter

"- All Purpose Date"."Year and Quarter"

- Study-Site Metrics

# Study-Sites

"- Study-Site Metrics"."# Study-Sites"

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

"Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]"

- Study-Site Metrics

Critical Document Package Complete to Site Initiated (# Days)

MEDIAN("- Study-Site Metrics"."Critical Document Package Complete to Site Initiated (# Days)")

KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

Line and line-bar graphs that show the region median compared to overall median and overall target for Critical Document Package Completed to Site Initiated (# Days), by quarter. Also includes a count of the number of studies that makes up the region median. This report compares region performance to overall performance and overall target for a given KPI.

Audience

- Region Manager Study Manager

Report Type

- View Selector (Multiple Graphs)

Location

- Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

- Study-Site, All Purpose Date

Supplementary Prompts

- Year and Month Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-43 describes the columns in the KPI Summary: CDP Completed to Site Initiated (Region Manager View) analysis.

Table A-43 KPI Summary: CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Quarter

"- All Purpose Date"."Year and Quarter"

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

"Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]"

- Study-Site Metrics

Critical Document Package Complete to Site Initiated (# Days)

MEDIAN("- Study-Site Metrics"."Critical Document Package Complete to Site Initiated (# Days)")

- Study-Site Metrics

# Study-Sites

"- Study-Site Metrics"."# Study-Sites"

- Overall Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

"- Overall Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]"

- All Purpose Date

Year

"- All Purpose Date"."Year"

KPI Summary - LSLV to Database Lock (Executive View) (Report CDA-CO-906)

Line and line-bar graphs that show the overall median compared to the overall target for Last Subject Last Visit to Database Lock (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

- Executive

Report Type

- Multiple Graphs (View selector)

Location

- Executive dashboard, KPI Summary page

Dimensions

- All Purpose Date, Overall Level Targets

Supplementary Prompts

- Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-44 describes the columns in the KPI Summary: LSLV to Database Lock (Executive View) analysis.

Table A-44 KPI Summary: LSLV to Database Lock (Executive View) (Report CDA-CO-906)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Quarter

"- All Purpose Date"."Year and Quarter"

- Study Metrics

# Studies

"- Study Metrics"."# Studies"

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

"Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"

- Study Metrics

[Last Subject Last Visit to Database Lock (# Days)]

MEDIAN("- Study Metrics"."[Last Subject Last Visit to Database Lock (# Days)]")

KPI Summary - Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)

Line and line-bar graphs that show the overall median compared to the overall target for Protocol Approved to 1st Site Initiated (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

- Executive

Report Type

- Multiple Graphs (View selector)

Location

- Executive dashboard, KPI Summary page

Dimensions

- 1st Site Initiated Date, Overall Level Targets

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-45 describes the columns in the KPI Summary: Protocol Approved to 1st Site Initiated (Executive View) analysis.

Table A-45 KPI Summary: Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- 1st Site Initiated Date

Year and Quarter

"- 1st Site Initiated Date"."Year and Quarter"

- Study Metrics

# Studies

"- Study Metrics"."# Studies"

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

"Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

MEDIAN("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]")

KPI Summary - Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)

Line and line-bar graphs that show the overall median compared to the overall target for Protocol Approved to 1st Subject Enrolled (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

- Executive

Report Type

- Multiple Graphs (View selector)

Location

- Executive dashboard, KPI Summary page

Dimensions

- 1st Subject Enrolled Date, Overall level Targets

Supplementary Prompts

- Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-46 describes the columns in the KPI Summary: Protocol Approved to 1st Subject Enrolled (Executive View) analysis.

Table A-46 KPI Summary: Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- 1st Subject Enrolled Date

Year and Quarter

"- 1st Subject Enrolled Date"."Year and Quarter"

- Study Metrics

# Studies

"- Study Metrics"."# Studies"

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

MAX("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]")

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

MEDIAN("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]")

KPI Summary - Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)

Line and line-bar graphs that show the overall median compared to the overall target for Site Visit Completed to Visit Report Completed (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

- Executive

Report Type

- Multiple Graphs (View selector)

Location

- Executive dashboard, KPI Summary page

Dimensions

- Visit Report Completed Date, Overall Level Targets

Supplementary Prompts

- Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-47 describes the columns in the KPI Summary: Site Visit Completed to Visit Report Completed (Executive View) analysis.

Table A-47 KPI Summary: Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Visit Report Completed Date

Year and Quarter

"- Visit Report Completed Date"."Year and Quarter"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

KPI Summary - Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

Line and line-bar graphs that show the region median compared to overall median and overall target for Site Visit Completed to Visit Report Completed (# Days), by quarter. Also includes a count of the number of studies that makes up the region median. This report compares region performance to overall performance and overall target for a given KPI.

Audience

- Region Manager

- Study Manager

Report Type

- View Selector (Multiple Graphs)

Location

- Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

- All Purpose Date

Supplementary Prompts

- Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-48 describes the columns in the KPI Summary: Site Visit Completed to Visit Report Completed (Region Manager View) analysis.

Table A-48 KPI Summary: Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Visit Report Completed Date

Year and Quarter

"- Visit Report Completed Date"."Year and Quarter"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

- Overall Metrics

Median Site Visit Completed to Visit Report Completed (# Days)

"- Overall Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)"

- Visit Report Completed Date

Year

"- Visit Report Completed Date"."Year"

KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

Line and line-bar graphs that show the region median compared to overall median and overall target for Visit Report Completed to Visit Report Approved (# Days), by quarter. Also includes a count of the number of studies that makes up the region median. This report compares region performance to overall performance and overall target for a given KPI.

Audience

- Region Manager Study Manager

Report Type

- View Selector (Multiple Graphs)

Location

- Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

- Visit Report Approved Date

Supplementary Prompts

- Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-49 describes the columns in the KPI Summary: Visit Report Completed to Approved (Region Manager View) analysis.

Table A-49 KPI Summary: Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Visit Report Approved Date

Year and Quarter

"- Visit Report Approved Date"."Year and Quarter"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

"Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]"

- Site Visit Metrics

[# Days from Site Visit Completed to Visit Report Approved]

MEDIAN("- Site Visit Metrics"."[# Days from Site Visit Completed to Visit Report Approved]")

- Overall Metrics

Median Visit Report Completed to Visit Report Approved (# Days)

"- Overall Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)"

- Visit Report Approved Date

Year

"- Visit Report Approved Date"."Year"

KPI Summary - Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)

Line and line-bar graphs that show the overall median compared to the overall target for Visit Report Completed to Visit Report Approved (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

- Executive

Report Type

- Multiple Graphs (View selector)

Location

- Executive dashboard, KPI Summary page

Dimensions

- Visit Report Approved Date, Overall Level Targets

Supplementary Prompts

- Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-50 describes the columns in the KPI Summary: Visit Report Completed to Visit Report Approved (Executive View) analysis.

Table A-50 KPI Summary: Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Visit Report Approved Date

Year and Quarter

"- Visit Report Approved Date"."Year and Quarter"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

Overall Level Targets

[Target Site Visit Completed to Visit Report Approved (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Approved (# Days)]"

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

MEDIAN("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]")

Site Visit

[Site Visit Report Approved Date]

"Site Visit"."[Site Visit Report Approved Date]"

List Discrepancy (Query) Details (Report CDA-DM-245)

Lists open discrepancies (queries) and associated details, and is used as a detailed drill down report to list all discrepancies (queries) and associated details. This report can be used to explore the open discrepancies (queries), and identify any patterns or clusters through the use of sorting.

Audience

- Data Manager

Report Type

- Table

Location

None

Dimensions

- CRF

- Study-Site

- Subject

Supplementary Prompts

- Subject.Subject ID

- Discrepancies.Visit Name

- Discrepancies.CRF Name

- Discrepancies.Validation Procedure Name

- Discrepancies.Current Review Status

- Discrepancies.Discrepancy State

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

- Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

- Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

- Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

- Key EDC Processing Volumes (Report CDA-DM-305)

- Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

Column Descriptions

Table A-51 describes the columns in the List Discrepancy (Query) Details report.

Table A-51 List Discrepancy (Query) Details (Report CDA-DM-245)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

Study-Site

Study

Study-Site.Study Name

NA

Site

Study-Site.Site Name

NA

Subject ID

Subject.Subject ID

Visit

Name

Discrepancies.Visit Name

Visit

Number

Discrepancies.Complete Visit Number

NA

Days Open

Discrepancies.# Days Discrepancy Open

CRF

Name

CRF.Name

CRF

Page Section

Discrepancies.CRF Page Section

CRF

Question Group

Discrepancies.CRF Question Group

CRF

Question Name

Discrepancies.CRF Question Name

CRF

Question Occurrence

Discrepancies.CRF Question Occurrence

Discrepancy (Query)

Discrepancy (Query) ID

Discrepancies.Discrepancy ID

Discrepancy (Query)

Procedure Name

Discrepancies.Validation Procedure Name

Discrepancy (Query)

Review Status

Discrepancies.Current Review Status

Discrepancy (Query)

Comment Text

Discrepancies.Comment Text

Discrepancy (Query)

Sent in DCF

Discrepancies.Sent in DCF

Discrepancy (Query)

State

Discrepancies.Discrepancy State

List of Follow Up Items (Report CDA-CO-803)

Lists follow up items, including type, comments, and key dates.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

None

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- # Follow Up Items by Type (Multiple Study-Sites) (Report CDA-CO-810)

Column Descriptions

Table A-52 describes the columns in the List of Follow Up Items report.

Table A-52 List of Follow Up Items (Report CDA-CO-803)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Follow Up Item

Type

Follow Up Item Metrics.Follow Up Item Type

Follow Up Item

Description

Follow Up Item Metrics.Follow Up Item Description

Follow Up Item

Comments

Follow Up Item Metrics.Follow Up Item Comments

Follow Up Item

Status

Follow Up Item Metrics.Follow Up Item Status

Follow Up Item

Created Date

Follow Up Item Metrics.Follow Up Item Created Date

Follow Up Item

Due Date

Follow Up Item Metrics.Follow Up Item Due Date

Follow Up Item

Completed Date

Follow Up Item Metrics.Follow Up Item Completed Date

Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

Identifies specific eCRFs, and the process steps they are awaiting. This report lists, for a subject, the eCRFs which are awaiting processing. This information can be used to drive an activity.

Audience

- Data Manager

Report Type

- Table

Location

- Data Manager - EDC dashboard, Study Processing Detail page

Dimensions

- CRF

- Study-Site

- Subject

Supplementary Prompts

- Study

- Study-Site

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

- Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

Column Descriptions

Table A-53 describes the columns in the Key EDC processing volumes report.

Table A-53 Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

NA

NA

Study-Site.Study Name

Study-Site

Site

Study-Site.Site Name

Subject

Subject ID

Subject.Subject ID

Visit

Name

Received CRFs.Visit Name

Visit

Number

Received CRFs.Complete Visit Number

Visit

Date

Received CRFs.Visit Date

CRF

Name

CRF.Name

Processing Required

Not Verified

Received CRFs.Is not in Verified state

Processing Required

Awaiting Re-verification

Received CRFs.Is Awaiting Re-Verification

Processing Required

Not Approved

Received CRFs.Is not in Approved state

Processing Required

Requires Re-Approval

Received CRFs.s Awaiting Re-Approval

Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

Identifies specific CRFs, and the process steps they are awaiting. This report lists, for a subject, the pages which are awaiting processing. This information can be used to drive activity.

Audience

- Data Manager

Report Type

- Table

Location

- Data Manager - Paper dashboard, Study Processing Detail page

Dimensions

- CRF

- Subject

Supplementary Prompts

- Study

- Study-Site

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

- Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

Column Descriptions

Table A-54 describes the columns in the Listing of Subject-Pages, Awaiting Paper Processing report.

Table A-54 Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

NA

NA

Study-Site.Study Name

Subject

Subject ID

Subject.Subject ID

Visit

Name

Received CRFs.Visit Name

Visit

Number

Received CRFs.Complete Visit Number

Visit

Date

Received CRFs.Visit Date

CRF

Name

CRF.Name

Processing Required

Awaiting First Entry

Received CRFs.Is Awaiting First Entry completion

Processing Required

Awaiting Second Entry

Received CRFs.Is Awaiting Second entry completion

Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)

Identifies sites who are slow at approving eCRFs. This report indicates the top 25 sites whose approval rates are less than 80% of those eCRFs entered. This information can be identify poor performing sites. Note: The 80% rate is based on those studies where the sites are requested to approve eCRFs immediately after entry. For those studies where this process is not relevant, the 80% threshold can be reduced.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Graph, table (optional)

Location

- Data Manager - EDC dashboard, Key Rates page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-55 describes the columns in the Low Approved to Entered Rate - Worst Performers report.

Table A-55 Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Study Name

Received CRFs

% eCRFs Approved / Entry Complete

Received CRFs.% eCRFs Approved / Entry Complete

Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)

Identifies sites where verification has been slow. This report displays the top sites whose verification rates are less than 50% of those pages entered. This information can be used to identify CRA resource shortfalls.

Audience

- Data Manager

- CRA

- Project Manager

Report Type

- Graph, table (optional)

Location

- Data Manager - EDC dashboard, Key Rates page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-56 describes the columns in the Low Verified to Entered Rate - Worst Performers report.

Table A-56 Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Study Name

Received CRFs

% eCRFs Verified / Entry Complete

Received CRFs.% eCRFs Verified / Entry Complete

Median # Follow Up Items per Site for Study (Report CDA-CO-802)

Displays the median number of follow up items identified across all study-sites for a study, by type. This report indicates which types of issues are occurring at in the study most frequently.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study-Site Overview dashboard, Monitoring Metrics page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-57 describes the columns in the Median # Follow Up Items per Site for Study report.

Table A-57 Median # Follow Up Items per Site for Study (Report CDA-CO-802)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Count of Follow Up Items

COUNT(- Follow Up Item Metrics.Follow Up Item Created Date)

NA

Follow Up Item Type

Follow Up Item Metrics.Follow Up Item Type

NA

Study

Study-Site.Study

Monitoring Report Approval - Turnaround Time vs. Goal (Report CDA-CO-813)

Displays monitoring report approval cycle times in the form of a scatter plot, compared to a static goal, over time. This report indicates how many visit report approvals have fallen above or below a threshold over time.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Manager dashboard, Monitoring Metrics page

- CRA dashboard, Monitoring Metrics page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-58 describes the columns in the Monitoring Report Approval - Turnaround Time vs. Goal report.

Table A-58 Monitoring Report Approval - Turnaround Time vs. Goal (Report CDA-CO-813)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Site Visit Report Completed Date

Site Visit.Site Visit Report Completed Date

NA

# Days from Visit Report Completed to Visit Report Approved

- Site Visit Metrics.# Days from Visit Report Completed to Visit Report Approved

NA

Target

12

Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

Displays the number of visit report approvals within 10 days, between 10 and 20 days, and greater than 20 days. Displays the information over time. This report indicates how many visit report approvals fall within designated thresholds.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Manager dashboard, Monitoring Metrics page

- Region Manager dashboard, Visit Reports & Follow Up Items page

Dimensions

- All Purpose Date

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-59 describes the columns in the Monitoring Report Approval Turnaround Times report.

Table A-59 Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Days from Visit Report Completed to Visit Report Approved

Site Visit Metrics.# Days from Visit Report Completed to Visit Report Approved

NA

Category

TBD

Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

Displays the number of visit reports completed within 10 days, between 10 and 20 days, and greater than 20 days. Displays the information over time. This report indicates how many visit report completions fall within designated thresholds.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Manager dashboard, Monitoring Metrics page

- CRA dashboard, Monitoring Metrics page

- Region Manager dashboard, Visit Reports & Follow Up Items page

- Monitoring Metrics page

Dimensions

- All Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-60 describes the columns in the Monitoring Report Completion Turnaround Times report.

Table A-60 Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Days from Site Visit Completed to Visit Report Completed

Site Visit Metrics.# Days from Site Visit Completed to Visit Report Completed

NA

Indicator

TBD

Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

Shows count of outstanding visit reports, visit report approvals and follow up items

Audience

- Region Manager

Report Type

- Narrative

Location

- Region Manager dashboard, Overview page

Dimensions

- Study-Site

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

- Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

- Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

Reports Referencing This Report

You can navigate to the following reports from this report:

- Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

- Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

Column Descriptions

Table A-61 describes the columns in the Monitoring Status Overview (Region Manager View) analysis

Table A-61 Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Study-Site Metrics

# Visit Reports Awaiting Completion

sum("- Study-Site Metrics"."# Visit Reports Awaiting Completion")

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

sum("- Study-Site Metrics"."[# Visit Reports Awaiting Approval]")

- Site Visit Metrics

# Outstanding Follow Up Items

sum ("- Site Visit Metrics"."# Outstanding Follow Up Items")

Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

Shows count of outstanding visit reports, visit report approvals and follow up items

Audience

- Study Manager

Report Type

- Narrative

Location

- Study Manager dashboard, Overview page

Dimensions

- Study

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

- Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

- Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

Reports Referencing This Report

None

Column Descriptions

Table A-62 describes the columns in the Monitoring Status Overview (Study Manager View) analysis.

Table A-62 Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Study-Site Metrics

# Visit Reports Awaiting Completion

sum("- Study-Site Metrics"."# Visit Reports Awaiting Completion")

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

sum("- Study-Site Metrics"."[# Visit Reports Awaiting Approval]")

- Site Visit Metrics

# Outstanding Follow Up Items

sum ("- Site Visit Metrics"."# Outstanding Follow Up Items")

Number of Studies (Report CDA-CO-1001)

Pie chart that shows count of studies. Column selector allows user to view by Therapeutic Area, Program, or Phase.

Audience

- Executive

Report Type

- Pie Chart (View Selector)

Location

- Executive dashboard, Overview page

Dimensions

- Study

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-63 describes the columns in the Number of Studies analysis

Table A-63 Number of Studies (Report CDA-CO-1001)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Study Metrics

# Studies

"- Study Metrics"."# Studies"

Study

Study Phase

"Study"."Study Phase"

Study

Program

"Study"."Program"

Study

Therapeutic Area

"Study"."Therapeutic Area"

Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-826)

Lists all completed monitoring reports that have not yet been approved, where the number of days since Monitoring Report Completed is within 5 days of meeting overall target. This report indicates which outstanding approvals are at risk of missing the overall target

Audience

- Region Manager

Report Type

- Table

Location

None

Dimensions

- Study-Site, Site Visit

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

Column Descriptions

Table A-64 describes the columns in the Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved analysis

Table A-64 Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-826)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

Site Visit Report Completed Date

TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF("CURRENT_DAY"))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

[Site Visit Report Approved Date]

"Site Visit"."[Site Visit Report Approved Date]"

Site Visit

Days Since Completed

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF(CURRENT_DAY)) >=("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" - 5) THEN 1 ELSE 0 END

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF(CURRENT_DAY)) >=("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" - 5) THEN 1 ELSE 0 END

Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-828)

Lists all completed monitoring reports that have not yet been approved, where the number of days since Monitoring Report Completed is greater than the overall target. This report indicates which outstanding approvals have already missed the overall target.

Audience

- Region Manager

Report Type

- Table

Location

None

Dimensions

- Study-Site, Site Visit

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

Column Descriptions

Table A-65 describes the columns in the Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved analysis

Table A-65 Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-828)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

Days Since Completed

TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF(CURRENT_DAY))

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

"Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]"

Outstanding Documents List (Report CDA-CO-602)

Lists all site documents that have been sent but not received from the study-site. This report indicates which study-site-level documents need to be collected.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

None

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Uninitiated Sites (Report CDA-CO-304)

Column Descriptions

The table describes the columns in the Outstanding Documents List report.

Table A-66 Outstanding Documents List (Report CDA-CO-602)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Activity Type

Document Metrics.Activity Type

NA

Document Name

Document Metrics.Document Name

NA

Days Since Doc Sent

TIMESTAMPDIFF(SQL_TSI_DAY, - Document Metrics.Document Sent Date,NOW())

NA

Document Comments

Document Metrics.Document Comments

Outstanding Follow up Items - Study Overview (Report CDA-CO-805)

Lists the outstanding follow up items for the study. This report indicates which active issues the study is encountering during monitoring visits, and how long they've been open.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Monitoring Metrics page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Follow up Items - Study Overview report.

Table A-67 Outstanding Follow up Items - Study Overview (Report CDA-CO-805)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

CRA

Study-Site.CRA

Site Visit Follow Up Item Metrics

Follow Up Item Type

Follow Up Item Metrics.Follow Up Item Type

Site Visit Follow Up Item Metrics

Follow Up Item Status

Follow Up Item Metrics.Follow Up Item Status

Site Visit Follow Up Item Metrics

Follow Up Item Description

Follow Up Item Metrics.Follow Up Item Description

Site Visit Follow Up Item Metrics

Follow Up Item Comments

Follow Up Item Metrics.Follow Up Item Comments

Site Visit Follow Up Item Metrics

# Days Follow Up Item Open

Follow Up Item Metrics.# Days Follow Up Item Open

Indicator

Indicator

TBD

Outstanding Follow up Items (CRA View) (Report CDA-CO-806)

Lists the outstanding follow up items. This report indicates which active issues are occurring during monitoring visits, and how long they've been open.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, CRA Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Follow up Items (CRA View) report.

Table A-68 Outstanding Follow up Items (CRA View) (Report CDA-CO-806)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Site Visit Metrics

Type

Site Visit.Site Visit Type

Site Visit Metrics

Start Date

Site Visit.Site Visit Start Date

Site Visit Metrics

Completed Date

Site Visit.Site Visit Completed Date

Site Visit Follow Up Item Metrics

Type

Follow Up Item Metrics.Follow Up Item Type

Site Visit Follow Up Item Metrics

Status

Follow Up Item Metrics.Follow Up Item Status

Site Visit Follow Up Item Metrics

Description

Follow Up Item Metrics.Follow Up Item Description

Site Visit Follow Up Item Metrics

Comments

Follow Up Item Metrics.Follow Up Item Comments

Site Visit Follow Up Item Metrics

# Days Outstanding

Follow Up Item Metrics.# Days Follow Up Item Outstanding

NA

Indicator

TBD

Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

Lists the outstanding follow up items for the study. This report indicates which active issues the study is encountering during monitoring visits, and how long they've been open.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Table

Location

- Study Manager dashboard, Monitoring Metrics page

- Region Manager dashboard, Visit Reports & Follow Up Items page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Follow up Items (Study Manager View) report.

Table A-69 Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

CRA

Study-Site.CRA

Site Visit Follow Up Item Metrics

Type

Follow Up Item Metrics.Follow Up Item Type

Site Visit Follow Up Item Metrics

Status

Follow Up Item Metrics.Follow Up Item Status

Site Visit Follow Up Item Metrics

Description

Follow Up Item Metrics.Follow Up Item Description

Site Visit Follow Up Item Metrics

Comments

Follow Up Item Metrics.Follow Up Item Comments

Site Visit Follow Up Item Metrics

# Days Open

Follow Up Item Metrics.# Days Follow Up Item Open

NA

Indicator

TBD

Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)

Lists all follow up items that have not been completed in the study-region. This report indicates which follow up items need to be resolved.

Audience

- Study Manager CRA

Report Type

- Table

Location

- Study-Region Overview dashboard, Visit Reports and Follow Up Items page

Dimensions

- Study-Site

Supplementary Prompts

- Visit Reports and Follow Up Items page prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-70 describes the columns in the Outstanding Follow up Items (Study-Region Overview) analysis

Table A-70 Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Study-Site

CRA

"Study-Site"."CRA"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

- Follow Up Item Metrics

Follow Up Item Type

"- Follow Up Item Metrics"."Follow Up Item Type"

- Follow Up Item Metrics

Follow Up Item Status

"- Follow Up Item Metrics"."Follow Up Item Status"

- Follow Up Item Metrics

Follow Up Item Description

"- Follow Up Item Metrics"."Follow Up Item Description"

- Follow Up Item Metrics

Follow Up Item Comments

"- Follow Up Item Metrics"."Follow Up Item Comments"

- Follow Up Item Metrics

# Days Follow Up Item Open

"- Follow Up Item Metrics"."# Days Follow Up Item Open"

- Follow Up Item Metrics

# Days Follow Up Item Outstanding

"- Follow Up Item Metrics"."# Days Follow Up Item Outstanding"

- Follow Up Item Metrics

Indicator

CASE WHEN ROUND("- Follow Up Item Metrics"."# Days Follow Up Item Outstanding" , 1)>60 THEN '1-Red' WHEN ROUND("- Follow Up Item Metrics"."# Days Follow Up Item Outstanding", 1) BETWEEN 30 AND 60 THEN '2-Yellow' WHEN ROUND("- Follow Up Item Metrics"."# Days Follow Up Item Outstanding", 1)<30 THEN '3-Green' ELSE '' END

Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)

Lists all follow up items that have not been completed. This report indicates which follow up items need to be resolved.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Visit Reports and Follow up Items page

Dimensions

- Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Follow up Items (Study-Site Overview) report.

Table A-71 Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Site Visit Metrics

Type

Site Visit.Site Visit Type

Site Visit Metrics

Start Date

Site Visit.Site Visit Start Date

Site Visit Metrics

Completed Date

Site Visit.Site Visit Completed Date

Site Visit Follow Up Item Metrics

Type

Follow Up Item Metrics.Follow Up Item Type

Site Visit Follow Up Item Metrics

Status

Follow Up Item Metrics.Follow Up Item Status

Site Visit Follow Up Item Metrics

Description

Follow Up Item Metrics.Follow Up Item Description

Site Visit Follow Up Item Metrics

Comments

Follow Up Item Metrics.Follow Up Item Comments

Site Visit Follow Up Item Metrics

# Days Open

Follow Up Item Metrics.# Days Follow Up Item Open

Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)

Lists all monitoring reports awaiting approval. This report indicates which monitoring reports require an action: review and approval.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, CRA Overview page

Dimensions

- Study-Site

- Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Report Approvals (CRA View) report.

Table A-72 Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Visit Type

Site Visit.Site Visit Type

NA

Site Visit Start Date

Site Visit.Site Visit Start Date

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

# Days Visit Report Approval Outstanding

Site Visit Metrics.# Days Visit Report Approval Outstanding

NA

Indicator

TBD

Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

Lists the monitoring reports that have been completed but not yet approved. This report indicates which monitoring reports require approval.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Table

Location

- Study Manager dashboard, Monitoring Metrics page

- Region Manager dashboard, Visit Reports & Follow Up Items page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Report Approvals (Study Manager View) report.

Table A-73 Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

CRA

Study-Site.CRA

NA

Study-Site Status

Study-Site.Study-Site Status

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

Site Visit Type

Site Visit.Site Visit Type

NA

# Days Visit Report Approval Outstanding

Site Visit Metrics.# Days Visit Report Approval Outstanding

NA

Indicator

TBD

Outstanding Monitoring Report Approvals (Study-Region) (Report CDA-CO-831)

Lists all monitoring reports awaiting approval in the study region. This report indicates which monitoring reports require an action: review and approval.

Audience

- Study Manager CRA

Report Type

- Table

Location

- Study-Region Overview dashboard, Monitoring Reports and Follow Up Items page

Dimensions

- Study-Site

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-74 describes the columns in the Outstanding Visit Report Approvals (Study-Region) analysis

Table A-74 Outstanding Visit Report Approvals (Study-Region) (Report CDA-CO-831)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Region

Region Name

"Study-Region"."Region Name"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Study-Site

CRA

"Study-Site"."CRA"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

- Site Visit Metrics

# Days Visit Report Approval Outstanding

"- Site Visit Metrics"."# Days Visit Report Approval Outstanding"

- Site Visit Metrics

Indicator

CASE when ROUND("- Site Visit Metrics"."# Days Visit Report Approval Outstanding", 1)>20 THEN '1-Red' WHEN (ROUND("- Site Visit Metrics"."# Days Visit Report Approval Outstanding", 1) >=10 and ROUND("- Site Visit Metrics"."# Days Visit Report Approval Outstanding" , 1)<= 20 )THEN '2-Yellow' WHEN ROUND("- Site Visit Metrics"."# Days Visit Report Approval Outstanding", 1) < 10 THEN '3-Green' ELSE '3-Green' END

Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)

Lists all monitoring reports awaiting approval at the study-site. This report indicates which monitoring reports require an action: review and approval.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Visit Reports and Follow up Items page

Dimensions

- Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Report Approvals (Study-Site) report.

Table A-75 Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Site Visit Type

Site Visit.Site Visit Type

NA

Site Visit Start Date

Site Visit.Site Visit Start Date

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

Site Visit Report Completed Date

Site Visit.Site Visit Report Completed Date

NA

# Days Visit Report Approval Outstanding

Site Visit Metrics.# Days Visit Report Approval Outstanding

NA

Indicator

CASE when - Site Visit Metrics.# Days Visit Report Approval Outstanding>20 THEN '1-Red' WHEN - Site Visit Metrics.# Days Visit Report Approval Outstanding between 11 and 20 THEN '2-Yellow' ELSE '3-Green' END

Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

Lists all monitoring reports awaiting completion. This report indicates which monitoring reports need to be completed and submitted for approval.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, CRA Overview page

Dimensions

- Study-Site

- Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

- Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

Column Descriptions

The table describes the columns in the Outstanding Monitoring Reports (CRA View) report.

Table A-76 Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Visit Type

Site Visit.Site Visit Type

NA

Site Visit Start Date

Site Visit.Site Visit Start Date

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

# Days Visit Report Completion Outstanding

Site Visit Metrics.# Days Visit Report Completion Outstanding

NA

Indicator

TBD

Outstanding Monitoring Reports (Study-Region View) (Report CDA-CO-830)

Lists all monitoring reports awaiting completion at the study region. This report indicates which monitoring reports need to be completed and submitted for approval.

Audience

- Region Manager Study Manager CRA

Report Type

- Table

Location

- Study-Region Overview dashboard, Monitoring Reports and Follow Up Items page

Dimensions

- Study-Site, Site Visit

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-77 describes the columns in the Outstanding Visit Reports (Study-Region View) analysis

Table A-77 Outstanding Visit Reports (Study-Region View) (Report CDA-CO-830)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Region

Region Name

"Study-Region"."Region Name"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Study-Site

CRA

"Study-Site"."CRA"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

- Site Visit Metrics

# Days Visit Report Completion Outstanding

"- Site Visit Metrics"."# Days Visit Report Completion Outstanding"

- Site Visit Metrics

Indicator

CASE WHEN ROUND("- Site Visit Metrics"."# Days Visit Report Completion Outstanding", 1)>20 THEN '1-Red' WHEN (ROUND("- Site Visit Metrics"."# Days Visit Report Completion Outstanding" , 1)>= 10 and ROUND("- Site Visit Metrics"."# Days Visit Report Completion Outstanding" , 1)<= 20) THEN '2-Yellow' WHEN ROUND("- Site Visit Metrics"."# Days Visit Report Completion Outstanding", 1) <10 then '3-Green' else '3-Green' END

Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)

Lists all monitoring reports awaiting completion at the study-site. This report indicates which monitoring reports need to be completed and submitted for approval.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Visit Reports and Follow up Items page

Dimensions

- Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Reports (Study-Site View) report.

Table A-78 Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Site Visit Type

Site Visit.Site Visit Type

NA

Site Visit Start Date

Site Visit.Site Visit Start Date

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

# Days Visit Report Completion Outstanding

Site Visit Metrics.# Days Visit Report Completion Outstanding

NA

Indicator

CASE WHEN - Site Visit Metrics.# Days Visit Report Completion Outstanding >20 THEN '1-Red' WHEN - Site Visit Metrics.# Days Visit Report Completion Outstanding between 10 and 20 THEN '2-Yellow' ELSE '3-Green' END

Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed (Report CDA-CO-824)

Lists all completed site visits that don't have completed visit reports, where the number of days since Site Visit Completed is within 5 days of meeting overall target. This report indicates which outstanding reports are at risk of missing the overall target.

Audience

- Region Manager

Report Type

- Table

Location

None

Dimensions

- Study-Site, Site Visit

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

Column Descriptions

Table A-79 describes the columns in the Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed analysis

Table A-79 Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed (Report CDA-CO-824)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Completed Date

TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF("CURRENT_DAY"))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

- Site Visit Metrics

# Days from Site Visit Start to Site Visit Completed

"- Site Visit Metrics"."# Days from Site Visit Start to Site Visit Completed"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

Days Since Completed

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF(CURRENT_DAY)) >=("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" - 5) THEN 1 ELSE 0 END

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF(CURRENT_DAY)) >=("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" - 5) THEN 1 ELSE 0 END

Outstanding Reports that Missed Target - Site Visit Completed to Visit Report Completed (Report CDA-CO-827)

Lists all completed site visits that don't have completed visit reports, where the number of days since Site Visit Completed is greater than the overall target. This report indicates which outstanding reports have already missed the overall target.

Audience

- Region Manager

Report Type

- Table

Location

None

Dimensions

- Study-Site, Site Visit

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

- Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

Column Descriptions

Table A-80 describes the columns in the Outstanding Reports that Missed Target: Site Visit Completed to Visit Report Completed analysis

Table A-80 Outstanding Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-827)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Completed Date

TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF("CURRENT_DAY"))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Days Since Completed

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF(CURRENT_DAY)) > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF(CURRENT_DAY)) > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Pages Awaiting Entry Completion (Report CDA-DM-450)

Identifies specific subjects who have CRFs awaiting processing. This report indicates those subjects which require processing, and the number of CRFs to be processed. This information can be used as a summary work log to drive activity.

Audience

- Data Entry Manager

- Data Manager

Report Type

- Graph, table (optional)

Location

- Data Manager - Paper dashboard, Home page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Pages Awaiting Entry Completion report.

Table A-81 Pages Awaiting Entry Completion (Report CDA-DM-450)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Study Name

# CRFs

Awaiting First Entry Completion

Received CRFs.# pCRFs Awaiting Pass 1 Entry Completion

# CRFs

Awaiting Second Entry Completion

Received CRFs.# pCRFs Awaiting Pass 2 Entry Completion

Paper Processing - Longest Cycle Times (Report CDA-DM-415)

Identifies the cycle times from subject visit to entry completion. This report displays the top studies with the longest cycle times for paper processing. This information can be used to highlight process inefficiencies and potential resource shortfalls.

Audience

- Data Manager

Report Type

- Graph, table (optional)

Location

- Data Manager - Paper dashboard, Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Paper Processing - Longest Cycle Times report.

Table A-82 Paper Processing - Longest Cycle Times (Report CDA-DM-415)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Study Name

Received CRFs

Avg # Days from First Entry to Second Entry Complete

Received CRFs.Avg # Days from pCRF First Entry to Second Entry Complete

Received CRFs

Avg # Days from Visit to First Entry

Received CRFs.Avg # Days from pCRF Visit to First Entry

Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

Displays a summary of site visit performance metrics for monitoring report completion and approval cycle times. For completed cycles, it displays the number and percentage of missed targets. For cycles that have not yet completed, it displays the number and percentage of missed targets and those at risk of missing a target. This report includes hyperlinks to related lists of monitoring reports.

Audience

- Region Manager Study Manager

Report Type

- Narrative

Location

- Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

- Site Visit

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-823)

- Outstanding Reports that Missed Target - Site Visit Completed to Visit Report Completed (Report CDA-CO-827)

- Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed (Report CDA-CO-824)

- Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-825)

- Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-828)

- Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-826)

Reports Referencing This Report

None

Column Descriptions

Table A-83 describes the columns in the Performance Metrics Summary Narrative: Site Visit analysis

Table A-83 Performance Metrics Summary Narrative: Site Visit (Report CDA-CO-1110)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Study-Site Metrics

# Completed Visits

"- Study-Site Metrics"."# Completed Site Visits"

- Site Visit Metrics

# Visit Reports that Missed Target

SUM(CASE WHEN "- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed" > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END)

Overall Level Targets

# Visit Reports that Missed Target (%)

SUM(CASE WHEN "- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed" > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END)

- Study-Site Metrics

# Completed Visits Awaiting Monitoring Report

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Site Visit Metrics

# Visits that Missed Target

SUM(CASE WHEN "- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed" > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END)/("- Study-Site Metrics"."# Visit Reports")* 100

Site Visit

# Visits at Risk of Missing Target

SUM(CASE WHEN "Site Visit"."Site Visit Completed Date" IS NOT NULL AND "Site Visit"."Site Visit Report Completed Date" IS NOT NULL AND TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END)

Site Visit

# Visits with Monitoring Report Approved

FILTER("- Study-Site Metrics"."# Visit Reports" USING ("Site Visit"."[Site Visit Report Approved Date]" IS NOT NULL))

- Site Visit Metrics

# Visits that Missed Target

SUM(CASE WHEN "- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]" > "Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" THEN 1 ELSE 0 END)

- Study-Site Metrics

# Completed Reports Awaiting Approval

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

Site Visit

# Visits that Missed Target

SUM(CASE WHEN "Site Visit"."Site Visit Report Completed Date" IS NOT NULL AND "Site Visit"."[Site Visit Report Approved Date]" IS NULL AND TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" THEN 1 ELSE 0 END)/ "- Study-Site Metrics"."[# Visit Reports Awaiting Approval]" * 100

Site Visit

# Visits at Risk of Missing Target

SUM(CASE WHEN "Site Visit"."Site Visit Report Completed Date" IS NOT NULL AND "Site Visit"."[Site Visit Report Approved Date]" IS NULL AND TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF("CURRENT_DAY")) >= ("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]"-5) AND TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF("CURRENT_DAY")) <= "Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" THEN 1 ELSE 0 END)/"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]" * 100

Protocol Deviations (Study-Site) by Category (Report CDA-CO-1301)

Displays the pie chart with the number of Study-Site related Protocol Deviations for a Study, by category.

Audience

- Study Manager

- CRA

Report Type

- Pie Chart

- Table

Location

- Study Overview dashboard, Protocol Deviations page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)

Reports Referencing This Report

None

Protocol Deviations (Subject) by Category (Report CDA-CO-1302)

Displays the pie chart with the number of Subject related Protocol Deviations for a Study, by category.

Audience

- Study Manager

- CRA

Report Type

- Pie Chart

- Table

Location

- Study Overview dashboard, Protocol Deviations page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)

Reports Referencing This Report

None

Protocol Deviations (Study-Site) Tile (Report CDA-CO-1303)

Displays the tile with the number of Study-Site related Protocol Deviations for a Study.

Audience

- Study Manager

- CRA

Report Type

- Tile

Location

- Study Overview dashboard, Protocol Deviations page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)

Reports Referencing This Report

None

Protocol Deviations (Subject) Tile (Report CDA-CO-1304)

Displays the tile with the number of Subject related Protocol Deviations for a Study.

Audience

- Study Manager

- CRA

Report Type

- Tile

Location

- Study Overview dashboard, Protocol Deviations page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)

Reports Referencing This Report

None

Protocol Deviations Overview by Study-Site (Report CDA-CO-1305)

Lists the number of times a Study-Site has had either a Study-Site or Subject related Protocol Deviation for a particular Study.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Protocol Deviations page

Dimensions

- Study-Site

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)

Displays the details of the Study-Site related Protocol Deviations for a Study.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview - Protocol Deviations dashboard

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Protocol Deviation (Subject) Details (Report CDA-CO-1307)

Displays the details of Subject related Protocol Deviations for a Study.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview - Protocol Deviations dashboard

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Protocol Versions (Report CDA-CO-115)

Lists details for the different versions of a protocol, including approved date, version number and comments.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- List

Location

- Not included on a dashboard

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

Screen Failure Reason (Report CDA-CO-420)

Displays number screen failures for a study-site, by screen failure reason. This report indicates the distribution of screen failure reasons among subjects who failed screening.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study-Site Overview dashboard, Screening and Recruitment Overview page

Dimensions

- Subject

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Subjects who Failed Screening (Report CDA-CO-428)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screen Failure Reason report.

Table A-84 Screen Failure Reason (Report CDA-CO-420)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Screen Failure Reason

Subject.Screen Failure Reason

NA

Count of Screen Failure Reasons

COUNT(Subject.Screen Failure Reason)

Screen Failure Reason (Report CDA-CO-425)

Displays (by screen failure reason) the number of subjects who failed screening. This report indicates which screen failure reasons account for the most screen failures.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, table (optional)

Location

- Study Overview dashboard, Screening Overview page

- Study-Region Overview dashboard, Screening Overview page

Dimensions

- Subject

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Subjects who Failed Screening (Report CDA-CO-428)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screen Failure Reason report.

Table A-85 Screen Failure Reason (Report CDA-CO-425)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Subject

Screen Failure Reason

Subject.Screen Failure Reason

NA

Subject Status

COUNT(- Subject Metrics.Subject Status)

Screen Failure Reason by Site (Report CDA-CO-300)

Displays (by site) the number of subjects who failed screening. This report indicates which screen failure reasons account for the most screen failures.

Audience

- Study Manager

- CRA

Report Type

- Graph, table (optional)

Location

- Study Overview dashboard, Screening Overview page

- Study Region Overview dashboard, Screening Overview page

Dimensions

- Subject

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Subjects who Failed Screening (Report CDA-CO-428)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screen Failure Reason by Site report.

Table A-86 Screen Failure Reason by Site (Report CDA-CO-300)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Subject Status

COUNT(- Subject Metrics.Subject Status)

Subject

Screen Failure Reason

Subject.Screen Failure Reason

Study-Site

Study, Site, and Investigator

Study-Site.Study, Site, and Investigator

Screening Overview (Study Level) (Report CDA-CO-407)

Displays a summary of screening information for a study. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study Overview dashboard, Screening Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screening Overview (Study Level) report.

Table A-87 Screening Overview (Study Level) (Report CDA-CO-407)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

# Planned

Study Metrics.# Subjects Planned for Study

NA

# Screened

Study-Site Metrics.# Screened

NA

# Re-Screened

Study-Site Metrics.# Re-Screened

NA

# Screen Failure

Study-site Metrics.# Screen Failure

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

% Enrolled / Planned

Study Metrics.% Enrolled / Planned in Study

NA

# Randomized

Study-site Metrics.# Randomized

NA

% Randomized / Planned

Study Metrics.% Randomized vs. Planned Study

Screening Overview (Study-Region Level) (Report CDA-CO-434)

Displays a summary of screening information for a study. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study.

Audience

- Region Manager

Report Type

- Narrative

Location

- Study-Region Overview dashboard, Screening Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-88 describes the columns in the Screening Overview (Study-Region Level) analysis

Table A-88 Screening Overview (Study-Region Level) (Report CDA-CO-434)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Study Region Metrics

# Subjects Planned for Study-Region

"- Study Region Metrics"."# Subjects Planned for Study-Region"

- Study-Site Metrics

# Screened

"- Study-Site Metrics"."# Screened"

- Study-Site Metrics

# Re-Screened

"- Study-Site Metrics"."# Re-Screened"

- Study-Site Metrics

# Screen Failure

"- Study-site Metrics"."# Screen Failure"

- Study-Site Metrics

# Enrolled

"- Study-site Metrics"."# Enrolled"

- Study Region Metrics

% Enrolled to Total Planned at Study Region

"- Study Region Metrics"."% Enrolled to Total Planned at Study Region"

- Study-Site Metrics

# Randomized

"- Study-site Metrics"."# Randomized"

- Study Region Metrics

% Planned Subjects Randomized

"- Study Region Metrics"."% Planned Subjects Randomized"

Screening Overview (Study-Site Level) (Report CDA-CO-415)

Displays a summary of screening information for a study-site. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study-site.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study-Site Overview dashboard, Screening and Recruitment Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screening Overview (Study-Site Level) report.

Table A-89 Screening Overview (Study-Site Level) (Report CDA-CO-415)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

For Study:

# Planned

Study Metrics.# Subjects Planned for Study

For Study-Site:

# Planned

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Screened

Study-site Metrics.# Screened

NA

# Re-Screened

Study-site Metrics.# Re-Screened

NA

# Screen Failure

Study-site Metrics.# Screen Failure

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

% Planned Site Enrollment Completed

Study-site Metrics.% of Planned Site Enrollment Completed

NA

% of Total Enrolled in Study

Study-site Metrics.% of Total Enrolled in Study

NA

# Randomized

Study-site Metrics.# Randomized

NA

% Randomized / Planned - Study

Study Metrics.% Randomized vs. Planned - Study

NA

% of Total Randomized in Study

Study-site Metrics.% of Total Randomized in Study

Screening vs. Enrollment by Region (Report CDA-CO-400)

Displays cumulative screening and enrollment by study region. This report indicates how each region in a study is progressing toward recruitment goals.

Audience

- Study Manager

- CRA

- Region Manager

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Screening Overview page

- Study Region Overview dashboard, Screening Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screening vs. Enrollment by Region report.

Table A-90 Screening vs. Enrollment by Region (Report CDA-CO-400)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Screened

Study-site Metrics.# Screened

Site Detail (Report CDA-CO-209)

Lists (by program, study, and region) site details, including status, and first subject screened, enrolled and randomized dates. This report indicates the progress of site selection and number of sites ready to enroll. It also indicates the sites and investigators selected.

Audience

- Study Manager

- CRA

Report Type

- Pivot Table

Location

None

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

- Enrollment Overview By Site (Report CDA-CO-426)

Column Descriptions

The table describes the columns in the Site Detail report.

Table A-91 Site Detail (Report CDA-CO-209)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Program

Study-Site.Program

NA

Product Name

Study-Site.Product Name

NA

Study

Study-Site.Study

NA

Study Status

Study.Study Status

NA

Study Region

Study-Site.Study Region

NA

Region Status

Region.Region Status

NA

Site Name

Study-Site.Site Name

NA

Principal Investigator

Study-Site.Principal Investigator

NA

CRA

Study-Site.CRA

NA

Study-Site Status

Study-Site.Study-Site Status

NA

First Subject Screened Date

Study-Site Metrics.First Subject Screened Date

NA

First Subject Enrolled Date

Study-Site Metrics.First Subject Enrolled Date

NA

First Subject Randomized Date

Study-Site Metrics.First Subject Randomized Date

NA

# Subjects Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Screened

Study-site Metrics.# Screened

NA

# Re-Screened

Study-site Metrics.# Re-Screened

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Randomized

Study-site Metrics.# Randomized

Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)

Provides a scatter plot displaying the number of completed site visits for a study-site compared to the study-site's contribution to the total enrollment for the study (% of Total Enrolled in Study). This report helps to identify which study-sites provide the most enrollment value for the least monitoring effort and vice versa.

Audience

- Study Manager

Report Type

- Scatter Plot

Location

- Study Overview dashboard, Site Performance page

Dimensions

- Study-Site

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-92 describes the columns in the Site Enrollment Performance Compared to Site Visit Frequency analysis

Table A-92 Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

- Study-Site Metrics

% of Total Enrolled in Study

"- Study-Site Metrics"."% of Total Enrolled in Study"

- Study-Site Metrics

# Completed Site Visits

"- Study-Site Metrics"."# Completed Site Visits"

Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)

Line-bar graph that shows the number of sites initiated compared to the number of sites planned for a Study-Region.

Audience

- Region Manager, Study Manager, Executive Manager, Program Manager

Report Type

- View Selector (Chart, Table)

Location

- Study-Region Overview dashboard, Overview page

Dimensions

- All Purpose Date

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-93 describes the columns in the Site Initiation Over Time Bar Chart (Study Region) analysis

Table A-93 Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Month

"- All Purpose Date"."Year and Month"

- Study Region Metrics

# Study-Sites Planned for Study-Region

"- Study Region Metrics"."# Study-Sites Planned for Study-Region"

- Study Region Metrics

# Study-Sites Initiated

"- Study Region Metrics"."# Study-Sites Initiated"

Site Recruitment Performance - Single Study (Report CDA-CO-416)

Shows the study-sites with 1 or more subjects enrolled, no subjects enrolled, or greater than 90% of planned enrollment completed, by region. Each bar displays the number of sites, and the line displays the percentage of sites. This report indicates how many sites are performing well or poorly with regard to subject recruitment.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Site Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Recruitment Performance - Single Study report.

Table A-94 Site Recruitment Performance - Single Study (Report CDA-CO-416)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

# Study-Sites

Study Metrics.# Study-Sites

NA

# Study-Sites with 1 or more Subjects Enrolled

Study Metrics.# Study-Sites with 1 or more Subjects Enrolled

NA

# Study-Sites with no Subjects Enrolled

Study Metrics.# Study-Sites - - Study Metrics.# Study-Sites with 1 or more Subjects Enrolled

NA

# Study-Sites Recruiting > 90% Planned Subjects

SUM(CASE WHEN - Study-site Metrics.% Enrolled to Total Planned at Study-Site>90.00 THEN 1 END BY Study-Site.Study Region)

NA

% with 1 or more Subjects Enrolled

((- Study Metrics.# Study-Sites with 1 or more Subjects Enrolled) *100) / (- Study Metrics.# Study-Sites)

NA

% with no Subjects Enrolled

((- Study Metrics.# Study-Sites - - Study Metrics.# Study-Sites with 1 or more Subjects Enrolled) *100) / (- Study Metrics.# Study-Sites)

NA

% Study-Sites Recruiting > 90% Planned Subjects

(SUM(CASE WHEN - Study-site Metrics.% Enrolled to Total Planned at Study-Site>90 THEN 1 END BY Study-Site.Study Region)*100)/- Study Metrics.# Study-Sites

Site Recruitment Performance (Report CDA-CO-413)

Shows the study-sites with 1 or more subjects enrolled, no subjects enrolled, greater than 90% of planned enrollment completed, or enrolling more than 1 subject but less than 90% of planned enrollment. This report indicates the distribution of top performing and non-performing study-sites.

Audience

- Executive

- Region Manager

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Site Performance page

- Executive dashboard, Site Recruitment Performance Summary page

- Study-Region Overview dashboard, Site Performance page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Recruitment Performance report.

Table A-95 Site Recruitment Performance (Report CDA-CO-413)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Category

TBD

NA

Study-Site ID #

Study-Site.Study-Site ID #

Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)

Shows the study-sites with 1 or more subjects enrolled, no subjects enrolled, or greater than 90% of planned enrollment completed, by program. Each bar displays the number of sites, and the line displays the percentage of sites. This report indicates how many sites are performing well or poorly with regard to subject recruitment.

Audience

- Region Manager

Report Type

- View Selector (Chart, Table)

Location

- Executive dashboard, Site Recruitment Performance Summary page

Dimensions

- Study-Site

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-96 describes the columns in the Site Recruitment Performance Charts (Executive View) analysis

Table A-96 Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Program

NA

Study Metrics

# Study-Sites

NA

Study Metrics

# Study-Sites with 1 or more Subjects Enrolled

NA

Study Metrics

# Sites Recruiting 0 Subjects

NA

Study Metrics

# Sites Recruiting at Least 90% of Planned Subjects

NA

Study Metrics

% Sites Recruiting 0 Subjects

NA

Study Metrics

% Sites Recruiting 1 or More Subjects

NA

Study Metrics

% Sites Recruiting at Least 90% of Planned Subjects

NA

Site Visit Analysis (Report CDA-CO-821)

Shows the number of site visits and median days form site visit start to site visit completed, over time. This report indicates the relationship between site visit duration and the number of site visits completed.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Monitoring Metrics page

Dimensions

- All-Purpose Date

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Visit Analysis report.

Table A-97 Site Visit Analysis (Report CDA-CO-821)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Site Visits

Study-site Metrics.# Site Visits

NA

Median # Days from Site Visit Start to Site Visit Completed

MEDIAN(- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

Site Visit Duration - Study (Report CDA-CO-808)

Displays the median duration of site visits that have taken place across all study-sites for this study, as well as the total number of completed site visits. This report indicates the median amount of time it might take to complete a site visit for a study.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Narrative

Location

- Study-Site Overview dashboard, Monitoring Metrics page

- Region Manager dashboard, Visit Reports & Follow Up Items page

Dimensions

- Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Visit Duration - Study report.

Table A-98 Site Visit Duration - Study (Report CDA-CO-808)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Median Site Visit Duration for Study

MEDIAN (- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

NA

Total Number Completed Site Visits for Study

COUNT (Site Visit.Site Visit Completed Date)

Site Visit Duration - Study Site (Report CDA-CO-800)

Displays the minimum, median, and maximum duration of site visits that have taken place at this study-site, as well as the total number of completed site visits. This report indicates the amount of time it might take to complete a site visit for a study-site.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study-Site Overview dashboard, Monitoring Metrics page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Visit Duration - Study Site report.

Table A-99 Site Visit Duration - Study Site (Report CDA-CO-800)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Min Site Visit Duration

MIN(- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

NA

Median Site Visit Duration

MEDIAN(- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

NA

Max Site Visit Duration

MAX(- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

NA

Total Number Completed Site Visits for Study-Site

COUNT (Site Visit.Site Visit Completed Date)

Site Visit Duration - Study-Region (Report CDA-CO-829)

Displays the minimum, median, and maximum duration of site visits that have taken place in this study-region, as well as the total number of completed site visits. This report indicates the amount of time it might take to complete a site visit for a study-site in this study-region.

Audience

- Region Manager

Report Type

- Narrative

Location

- Study-Region Overview dashboard, Visit Reports and Follow Up Items page

Dimensions

- Site Visit

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-100 describes the columns in the Site Visit Duration - Study-Region analysis.

Table A-100 Site Visit Duration - Study-Region (Report CDA-CO-829)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- Site Visit Metrics

Min Site Visit Duration

MIN("- Site Visit Metrics"."# Days from Site Visit Start to Site Visit Completed")

- Site Visit Metrics

Median Site Visit Duration

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Start to Site Visit Completed")

- Site Visit Metrics

Max Site Visit Duration

MAX("- Site Visit Metrics"."# Days from Site Visit Start to Site Visit Completed")

Site Visit

Total Number Completed Site Visits for Study-Region

COUNT("Site Visit"."Site Visit Completed Date")

Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

Lists study-sites, sorted by the number of days that have passed since the last site visit. Includes planned and actual milestones and recruitment details. This report indicates which sites might need to be monitored.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Sites to Monitor page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites to Monitor - Days Since Last Visit - Recruitment Detail View report.

Table A-101 Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Planned:',cast(MAX(ROUND("- Study Targets"."[Expected Screen Failure Rate]", 2)) as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."Screen Failure Rate", 2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Planned:',cast(MAX(ROUND("- Study Targets"."[Expected Screen Failure Rate]", 2)) as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."Screen Failure Rate", 2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

"- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site"

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

"- Study-Site Metrics"."% Randomized vs. Planned - Study-Site"

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

NA

Navigate to detail

NA

Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

Lists study-sites, sorted by the number of days that have passed since the last site visit. Includes planned and actual milestones and retention details. This report indicates which sites might need to be monitored.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Sites to Monitor page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites to Monitor - Days Since Last Visit - Retention Detail View report.

Table A-102 Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention Detail Reason

"- Study-Site Metrics"."Retention Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

NA

Navigate to detail

NA

Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

Lists study-sites, sorted by the number of days that have passed since the last site visit. Includes planned and actual milestones and retention details. This report indicates which sites might need to be monitored.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Sites to Monitor page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites to Monitor - Days Since Last Visit - Study Close Detail View report.

Table A-103 Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

"- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site"

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention Detail Reason

"- Study-Site Metrics"."Retention Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

NA

Navigate to detail

NA

Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

Lists study-sites, sorted by the number of days that have passed since the last site visit. Includes planned and actual milestones and monitoring details. This report indicates which sites might need to be monitored.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Sites to Monitor page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites to Monitor - Days Since Last Visit - Summary View report.

Table A-104 Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Study-Site Metrics

# Days Since Latest Site Visit

"- Study-Site Metrics"."# Days Since Latest Site Visit"

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

NA

Navigate to detail

NA

Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

Lists study-sites that have been initiated, but that have not yet had an interim monitoring visit. Includes subject recruitment information. This report indicates which sites might need to be monitored by identifying initiated sites that have not had an interim monitoring visit since initiation and whether they have screened or enrolled subjects.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Sites to Monitor page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites with No Visits Since Initiation - Recruitment Detail View report.

Table A-105 Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Planned:',cast(MAX(ROUND("- Study Targets"."[Expected Screen Failure Rate]", 2)) as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."Screen Failure Rate", 2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Planned:',cast(MAX(ROUND("- Study Targets"."[Expected Screen Failure Rate]", 2)) as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."Screen Failure Rate", 2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

"- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site"

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

"- Study-Site Metrics"."% Randomized vs. Planned - Study-Site"

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

NA

Navigate to Detail

NA

Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

Lists study-sites that have been initiated, but that have not yet had an interim monitoring visit. Includes subject retention information. This report indicates which sites might need to be monitored by identifying initiated sites that have not had an interim monitoring visit since initiation and whether they have randomized or enrolled subjects.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Sites to Monitor page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites with No Visits Since Initiation - Retention Detail View report.

Table A-106 Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention Detail Reason

"- Study-Site Metrics"."Retention Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

Lists study-sites that have been initiated, but that have not yet had an interim monitoring visit. Includes subject recruitment information. This report indicates which sites might need to be monitored by identifying initiated sites that have not had an interim monitoring visit since initiation, and whether they have enrolled subjects.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Sites to Monitor page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites with No Visits Since Initiation - Summary View report.

Table A-107 Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Study-Site Metrics

# Days Since Latest Site Visit

"- Study-Site Metrics"."# Days Since Latest Site Visit"

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

NA

Navigate to Detail

NA

Study Documents List (Report CDA-CO-600)

Lists all study documents collected, including document status, sent date, received date, and comments. This report indicates which study-level documents have been collected or are missing.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study Document List page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study Documents List report.

Table A-108 Study Documents List (Report CDA-CO-600)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Activity Type

Document Metrics.Activity Type

NA

Document Name

Document Metrics.Document Name

NA

Document Sent Date

Document Metrics.Document Sent Date

NA

Document Received Date

Document Metrics.Document Received Date

NA

Document Expiration Date

Document Metrics.Document Expiration Date

NA

Document Comments

Document Metrics.Document Comments

NA

Document Expiration Date Indicator

TBD

Study Enrollment Progress Gauge (Report CDA-CO-445)

Displays a gauge showing how many subjects have been enrolled in the study compared to the number of subjects planned for the study.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study Overview dashboard, Risk Profile page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Study Information (Report CDA-CO-103)

Displays a summary of identifying information for a study, including Study #, Program, Product and Study Status.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study Overview dashboard, Study Overview page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study Information report.

Table A-109 Study Information (Report CDA-CO-103)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study

Study.Study

NA

Program

Study.Program

NA

Product

Study.Product

NA

Short Title

Study.Study Short Title

NA

Status

Study.Study Status

NA

Phase

Study.Study Phase

NA

Study Manager

Study.Study Manager

Study List - Initiation Details (Report CDA-CO-305)

Lists studies that are not in a status of Completed or Planned and have not achieved 100% enrollment. Displays planned and actual number of sites, including how many are initiated, screening, and enrolling. This report provides a list of ongoing studies that have not yet achieved 100% enrollment, including number of study-sites to reach certain achievements.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Manager dashboard, Initiating and Recruiting Studies page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study List - Initiation Details report.

Table A-110 Study List - Initiation Details (Report CDA-CO-305)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study

Program

Study.Program

Study

Study

Study.Study

Study

Status

Study.Study Status

Study

Study Manager

"Study"."Study Manager"

- Study Metrics

Milestone Flag

"- Study Metrics"."Milestone Flag"

- Study Metrics

Milestone Detail Reason

"- Study Metrics"."Milestone Detail Reason"

Study Metrics, Counts

# Study-Sites Planned for Study

NA

Study Metrics, Counts

# Study-Sites Initiated

NA

Study Metrics, Counts

# Sites with 1 or More Subjects Screened

NA

Study Metrics, Counts

# Study-Sites with 1 or more Subjects Enrolled

NA

Study Metrics, Ratios

% of Planned Sites Initiated

NA

Study, Original Planned Dates

[Planned 1st IRB/EC Submission Date]

NA

Study, Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

NA

Study Metrics, Actual Milestones

[1st IRB/EC Submission Date]

NA

Study, Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

NA

Study, Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

NA

Study Metrics, Actual Milestones

1st Initial IRB/EC Approval Date

NA

Study, Original Planned Dates

[Planned 1st Site Initiated Date]

NA

Study, Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

NA

Study Metrics, Actual Milestones

1st Site Initiated Date

NA

Study, Original Planned Dates

[Planned Last Site Initiated Date]

NA

Study, Latest Estimated Dates

[Planned LE Last Site Initiated Date]

NA

Study Metrics, Actual Milestones

Latest Site Initiated Date

NA

Study Metrics, Actual Milestones

[Last Site Initiated Date]

NA

Study, Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

NA

Study, Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

NA

Study Metrics, Actual Milestones

[1st Critical Document Package Completed Date]

NA

Study, Original Planned Dates

[Planned Last Critical Document Package Completed Date]

NA

Study, Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

NA

Study Metrics, Actual Milestones

[Latest Critical Document Package Completed Date]

NA

Study Metrics, Actual Milestones

[Last Critical Document Package Completed Date]

NA

NA

Navigate to Detail

NA

Study List - KPI Performance (Report CDA-CO-904)

Provides a list of studies with target/actual KPIs and a KPI indicator. This report indicates whether a study is performing within target range for KPIs.

Audience

- Executive

Report Type

- Table (View Selector)

Location

None

Dimensions

- Study

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study Overview Dashboard

Reports Referencing This Report

You can navigate to the following reports from this report:

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

Column Descriptions

Table A-111 describes the columns in the Study List: KPI Performance analysis

Table A-111 Study List: KPI Performance (Report CDA-CO-904)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study

Program

"Study"."Program"

Study

Study

"Study"."Study"

Study

Study Status

"Study"."Study Status"

Study

Study Manager

"Study"."Study Manager"

- Study Metrics

KPI Indicator

"- Study Metrics"."KPI Indicator"

- Study Metrics

KPI Detail Reason

"- Study Metrics"."KPI Detail Reason"

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]", 2) as char(40))))||'

'||CONCAT('Actual:' , cast(ROUND("- Study Metrics"."% Sites Recruiting 0 Subjects", 2) as char(40)))

- Study Metrics

% Sites Recruiting 0 Subjects

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]", 2) as char(40))))||'

'||CONCAT('Actual:' , cast(ROUND("- Study Metrics"."% Sites Recruiting 0 Subjects", 2) as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' ,MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' ,MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]", 2) as char(40))))

- Study Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]", 2) as char(40))))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)", 2) as char(40))))

- Study Metrics

Median Site Visit Completed to Visit Report Completed (# Days)

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)", 2) as char(40))))

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]", 2) as char(40))))

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]", 2) as char(40))))

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)", 2) as char(40))))

- Study Metrics

Latest Subject Latest Visit to Database Lock (# Days)

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)", 2) as char(40))))

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))

- Study Key Dates

[Protocol Approved Date]

MIN("- Study Key Dates"."[Protocol Approved Date]")

- Study Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',MIN(cast("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))

- Study Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',MIN(cast("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))

- Study Key Dates

[Protocol Approved Date]

MIN("- Study Key Dates"."[Protocol Approved Date]")

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40)))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40)))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))

- Study Metrics

[Last Subject Last Visit to Database Lock (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))

- Study Original Planned Dates

[Planned Database Lock Date]

MIN("- Study Original Planned Dates"."[Planned Database Lock Date]")

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',MIN(cast("- Study Original Planned Dates"."[Planned Database Lock Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]" as char(40))))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',MIN(cast("- Study Original Planned Dates"."[Planned Database Lock Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]" as char(40))))

- Study Metrics

1st Site Initiated Date

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

[Protocol Approved Date]

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

1st Site Initiated Date

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

[Protocol Approved Date]

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

1st Site Initiated Date

"- Study Metrics"."1st Site Initiated Date"

- Study Metrics

1st Subject Enrolled Date

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

[Protocol Approved Date]

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

1st Subject Enrolled Date

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

[Protocol Approved Date]

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

Database Lock Date

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

Last Subject Last Visit Date

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

Database Lock Date

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

Last Subject Last Visit Date

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

1st Subject Enrolled Date

"- Study Metrics"."1st Subject Enrolled Date"

- Study Metrics

[Last Subject Last Visit Date]

"- Study Metrics"."[Last Subject Last Visit Date]"

- Study Key Dates

[Protocol Approved Date]

MIN("- Study Key Dates"."[Protocol Approved Date]")

- Study Key Dates

Database Lock Date

MIN("- Study Key Dates"."Database Lock Date")

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

"Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

"Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

"Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"

Study List - Milestone Performance (Report CDA-CO-109)

Provides a list of studies with planned, latest estimate and actual milestones, and a milestone indicator. This report indicates whether a study has exceeding planned dates for outstanding milestones.

Audience

- Study Manager

Report Type

- Table

Location

None

Dimensions

- Study

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study Overview Dashboard

- Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

Reports Referencing This Report

You can navigate from the following reports to this report:

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

Column Descriptions

Table A-112 describes the columns in the Study List: Milestone Performance analysis

Table A-112 Study List: Milestone Performance (Report CDA-CO-109)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study

Program

"Study"."Program"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study

Study Status

"Study"."Study Status"

Study

Study Manager

"Study"."Study Manager"

- Study Region Metrics

Milestone Flag

"- Study Region Metrics"."Milestone Flag"

- Study Region Metrics

Milestone Detail Reason

"- Study Region Metrics"."Milestone Detail Reason"

- Study Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'|| CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Metrics"."[1st IRB/EC Submission Date]" , 'dd-Mon-yyyy'))

- Study Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'|| CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Metrics"."[1st IRB/EC Submission Date]" , 'dd-Mon-yyyy'))

- Study Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'|| CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Metrics"."[1st IRB/EC Submission Date]" , 'dd-Mon-yyyy'))

- Study Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Metrics

1st Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Metrics

Latest Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Metrics

[Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

Latest Subject Enrollment Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Latestt):',cast( "- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast( "- Study Metrics"."[Last Subject Last Visit Date]"as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Latestt):',cast( "- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast( "- Study Metrics"."[Last Subject Last Visit Date]"as char(40)))

- Study Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Latestt):',cast( "- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast( "- Study Metrics"."[Last Subject Last Visit Date]"as char(40)))

- Study Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Latestt):',cast( "- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast( "- Study Metrics"."[Last Subject Last Visit Date]"as char(40)))

Study List - Recruitment Details (Report CDA-CO-406)

Lists studies that are not in a status of Completed or Planned and have not achieved 100% enrollment. Displays planned and actual recruitment information. This report provides a list of ongoing studies that have not yet achieved 100% enrollment, including recruitment information.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Manager dashboard, Initiating and Recruiting Studies page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study List - Recruitment Details report.

Table A-113 Study List - Recruitment Details (Report CDA-CO-406)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study

Program

Study.Program

Study

Study

Study.Study

Study

Status

Study.Study Status

Study

Study Manager

"Study"."Study Manager"

- Study Metrics

Recruitment Flag

"- Study Metrics"."Recruitment Flag"

- Study Metrics

Recruitment Detail Reason

"- Study Metrics"."Recruitment Detail Reason"

- Study Metrics

Milestone Flag

"- Study Metrics"."Milestone Flag"

- Study Metrics

Milestone Detail Reason

"- Study Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MIN(ROUND("- Study Targets"."[Expected Screen Failure Rate]",2)) as char(40)))||'<br/>'||CONCAT('Actual:',cast(ROUND("- Study Metrics"."Screen Failure Rate",2) as char(40)))

- Study Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MIN(ROUND("- Study Targets"."[Expected Screen Failure Rate]",2)) as char(40)))||'<br/>'||CONCAT('Actual:',cast(ROUND("- Study Metrics"."Screen Failure Rate",2) as char(40)))

- Study Metrics

% Planned Subjects Enrolled (Study)

CONCAT('Actual:',cast(ROUND("- Study Metrics"."% Planned Subjects Enrolled (Study)",2) as char(40)))

- Study Metrics

% Planned Subjects Randomized (Study)

CONCAT('Actual:',cast(ROUND("- Study Metrics"."% Planned Subjects Randomized (Study)",2) as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

Latest Subject Enrollment Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

NA

Navigate to Detail

NA

Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

Lists (for a study) key milestone dates and enrollment, enrollment progress, and study-health indicator. This report indicates whether a study requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study List - Initiation Details (Report CDA-CO-305)

- Study List - Recruitment Details (Report CDA-CO-406)

- Protocol Versions (Report CDA-CO-115)

Column Descriptions

The table describes the columns in the Study Milestone with Indicators (Study Overview) report.

Table A-114 Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study

Program

"Study"."Program"

Study

Study

"Study"."Study"

Study

Study Manager

"Study"."Study Manager"

- Study Metrics

Recruitment Flag

"- Study Metrics"."Recruitment Flag"

- Study Metrics

Recruitment Detail Reason

"- Study Metrics"."Recruitment Detail Reason"

- Study Metrics

Retention Flag

"- Study Metrics"."Retention Flag"

- Study Metrics

Retention Detail Reason

"- Study Metrics"."Retention Detail Reason"

- Study Metrics

Milestone Flag

"- Study Metrics"."Milestone Flag"

- Study Metrics

Milestone Detail Reason

"- Study Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('[Expected]:',cast(MIN("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."Screen Failure Rate" as char(40)))

- Study Metrics

Screen Failure Rate

CONCAT('[Expected]:',cast(MIN("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."Screen Failure Rate" as char(40)))

- Study Metrics

% of Planned Sites Initiated

CONCAT('Actual:',cast("- Study Metrics"."% of Planned Sites Initiated" as char(40)))

- Study Metrics

% Planned Subjects Enrolled (Study)

CONCAT('Actual:',cast("- Study Metrics"."% Planned Subjects Enrolled (Study)" as char(40)))

- Study Targets

Expected Early Termination Rate

CONCAT('[Expected]:',cast(MIN("- Study Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."% Subjects Early Terminated for Study") as char(40)))

- Study Metrics

% Subjects Early Terminated for Study

CONCAT('[Expected]:',cast(MIN("- Study Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."% Subjects Early Terminated for Study") as char(40)))

- Study Metrics

% Planned Subjects Randomized (Study)

CONCAT('Actual:',cast("- Study Metrics"."% Planned Subjects Randomized (Study)" as char(40)))

- Study Key Dates

[Protocol Approved Date]

CONCAT('Actual:',cast(MIN("- Study Key Dates"."[Protocol Approved Date]") as char(40)))

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."Database Lock Date") as char(40)))

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/ "- Discrepancies"."# Total Discrepancies")

- Discrepancies (Queries)

# Total Discrepancies (Queries)

("- Discrepancies"."# Days Discrepancy Open"/ "- Discrepancies"."# Total Discrepancies")

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."1st Subject Screened Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."1st Subject Screened Date") as char(40)))

- Study Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."1st Subject Screened Date") as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]"as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]"as char(40)))

- Study Metrics

Latest Subject Enrollment Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]"as char(40)))

- Study Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]"as char(40)))

- Study Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):' , cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):' , cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):' , cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):' , cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):' , cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):' , cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):' , cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):' , cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

# Study-Sites Planned for Study

CONCAT('Planned:',cast(MIN("- Study Metrics"."# Study-Sites Planned for Study") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Metrics"."# Study-Sites Initiated") as char(40)))

- Study Metrics

# Study-Sites Initiated

CONCAT('Planned:',cast(MIN("- Study Metrics"."# Study-Sites Planned for Study") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Metrics"."# Study-Sites Initiated") as char(40)))

- Study Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Metrics

1st Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Latestl:',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Last:',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Latestl:',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Last:',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Metrics

Latest Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Latestl:',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Last:',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Metrics

[Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Latestl:',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Last:',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Study Metrics

KPI Flag

"- Study Metrics"."KPI Flag"

- Study Metrics

KPI Detail Reason

"- Study Metrics"."KPI Detail Reason"

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]") as char(40)))||'<br/>'||CONCAT('Actual:' ,cast(MAX("- Study Metrics"."% Sites Recruiting 0 Subjects") as char(40)))

- Study Metrics

% Sites Recruiting 0 Subjects

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]") as char(40)))||'<br/>'||CONCAT('Actual:' ,cast(MAX("- Study Metrics"."% Sites Recruiting 0 Subjects") as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))

- Study Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)") as char(40)))

- Study Metrics

Median Site Visit Completed to Visit Report Completed (# Days)

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)") as char(40)))

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)") as char(40)))

- Study Metrics

Median Visit Report Completed to Visit Report Approved (# Days)

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)") as char(40)))

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)") as char(40)))

- Study Metrics

Latest Subject Latest Visit to Database Lock (# Days)

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)") as char(40)))

Study RACT (Report CDA-CO-852)

Displays the RACT (Risk Assessment Categorization Tool) for a Study. This analysis lists all the questions on the RACT with the scores for impact, probability, and detectability. It also lists any considerations, mitigations, or comments.

Audience

- Study Manager

- CRA

Report Type

- Tile

Location

- Not included on a dashboard

Dimensions

- Study

- RACT Category

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Study RACT by Category (Report CDA-CO-853)

Displays the RACT (Risk Assessment Categorization Tool) score, broken out by category for a Study.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Not included on a dashboard

Dimensions

- Study

- RACT Category

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study RACT (Report CDA-CO-852)

Reports Referencing This Report

- Study RACT Score Tile (Report CDA-CO-858)

Study RACT Score Tile (Report CDA-CO-858)

Displays the tile with the RACT (Risk Assessment Categorization Tool) score for a Study.

Audience

- Study Manager

- CRA

Report Type

- Tile

Location

- Study Overview dashboard, Risk Profile page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study RACT (Report CDA-CO-852)

- Study RACT by Category (Report CDA-CO-853)

Reports Referencing This Report

None

Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Region Overview Dashboard

- Study Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-115 describes the columns in the Study Region Milestones with Indicators - Data Management View analysis.

Table A-115 Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

Discrepancies (Queries)

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# TotalDiscrepancies")

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"�

Received CRFs

# CRFs Soft Locked (Frozen)

"- Received CRFs"."# CRFs Soft Locked"

Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

# CRFs Hard Locked (Locked)

"- Received CRFs"."# CRFs Hard Locked"

Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Region Overview Dashboard

- Study Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-116 describes the columns in the Study Region Milestones with Indicators - Recruitment Detail View analysis.

Table A-116 Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region Metrics, Ratios

% Planned Subjects Randomized

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Screened Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Screened Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject 1st Visit Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject 1st Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject 1st Visit Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Region Overview Dashboard

- Study Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-117 describes the columns in the Study Region Milestones with Indicators - Retention Detail View analysis.

Table A-117 Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Region Overview Dashboard

- Study Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-118 describes the columns in the Study Region Milestones with Indicators - Site Start Up Detail View analysis.

Table A-118 Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Counts

# Study-Sites Planned for Study-Region

NA

Study-Region Metrics, Counts

# Study-Sites Initiated

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Original Planned Dates

[Planned 1st IRB/EC Submission Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

NA

Study-Region Metrics, Actual Milestones

[1st IRB/EC Submission Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

NA

Study-Region Metrics, Actual Milestones

1st Initial IRB/EC Approval Date

NA

Study-Region, Original Planned Dates

[Planned 1st Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

NA

Study-Region Metrics, Actual Milestones

1st Site Initiated Date

NA

Study-Region, Original Planned Dates

[Planned Last Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Site Initiated Date]

NA

Study-Region Metrics, Actual Milestones

Latest Site Initiated Date

NA

Study-Region Metrics, Actual Milestones

[Last Site Initiated Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[1st Critical Document Package Completed Date]

NA

Study-Region, Original Planned Dates

[Planned Last Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Latest Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Last Critical Document Package Completed Date]

NA

Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Region Overview Dashboard

- Study Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-119 describes the columns in the Study Region Milestones with Indicators - Study Close Detail View analysis.

Table A-119 Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

Received CRFs

# CRFs Soft Locked

"- Received CRFs"."# CRFs Soft Locked"

Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

# CRFs Hard Locked

"- Received CRFs"."# CRFs Hard Locked"

Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study, Original Planned Dates

[Planned Clinical Study Report Date]

NA

Study, Latest Estimate Dates

[Planned LE Clinical Study Report Date]

NA

Study, Key Dates

[Clinical Study Report Date]

NA

Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Region Overview Dashboard

- Study Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-120 describes the columns in the Study Region Milestones with Indicators - Summary View analysis.

Table A-120 Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study Key Dates

[Protocol Approved Date]

max("- Study KeyDates"."[Protocol ApprovedDate]")

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study Region Milestones with Indicators (Single Study-Region) - Data Management View (Report CDA-CO-1116A)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Study-Region Overview dashboard, Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-121 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Data Management View analysis.

Table A-121 Study Region Milestones with Indicators (Single Study-Region) - Data Management View (Report CDA-CO-1116A)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

Discrepancies (Queries)

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/"-Discrepancies"."# TotalDiscrepancies")

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To beVerified"

Received CRFs

# CRFs Soft Locked (Frozen)

"- Received CRFs"."# CRFs Soft Locked"

Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

# CRFs Hard Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View (Report CDA-CO-1116B)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Study-Region Overview dashboard, Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-122 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View analysis.

Table A-122 Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View (Report CDA-CO-1116B)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region Metrics, Ratios

% Planned Subjects Randomized

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Screened Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Screened Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject 1st Visit Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject 1st Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject 1st Visit Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View (Report CDA-CO-1116C)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Study-Region Overview dashboard, Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-121 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View analysis.

Table A-123 Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View (Report CDA-CO-1116C)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View (Report CDA-CO-1116D)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Study-Region Overview dashboard, Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-124 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View analysis.

Table A-124 Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View (Report CDA-CO-1116D)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Counts

# Study-Sites Planned for Study-Region

NA

Study-Region Metrics, Counts

# Study-Sites Initiated

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Original Planned Dates

[Planned 1st IRB/EC Submission Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

NA

Study-Region Metrics, Actual Milestones

[1st IRB/EC Submission Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

NA

Study-Region Metrics, Actual Milestones

1st Initial IRB/EC Approval Date

NA

Study-Region, Original Planned Dates

[Planned 1st Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

NA

Study-Region Metrics, Actual Milestones

1st Site Initiated Date

NA

Study-Region, Original Planned Dates

[Planned Last Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Site Initiated Date]

NA

Study-Region Metrics, Actual

Latest Site Initiated Date

NA

Study-Region Metrics, Actual Milestones

[Last Site Initiated Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[1st Critical Document Package Completed Date]

NA

Study-Region, Original Planned Dates

[Planned Last Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Latest Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Last Critical Document Package Completed Date]

NA

Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View (Report CDA-CO-1116E)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Study-Region Overview dashboard, Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-121 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View analysis.

Table A-125 Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View (Report CDA-CO-1116E)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To beVerified"

Received CRFs

# CRFs Soft Locked

"- Received CRFs"."# CRFs Soft Locked"

Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

# CRFs Hard Locked

"- Received CRFs"."# CRFs Hard Locked"

Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study, Original Planned Dates

[Planned Clinical Study Report Date]

NA

Study, Latest Estimate Dates

[Planned LE Clinical Study Report Date]

NA

Study, Key Dates

[Clinical Study Report Date]

NA

Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- View Selector (Multiple Tables)

Location

- Study-Region Overview dashboard, Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-126 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Summary View analysis.

Table A-126 Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study Key Dates

[Protocol Approved Date]

max("- Study KeyDates"."[Protocol ApprovedDate]")

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)

Line bar chart with bar for each study-region reflecting value for each study region and a point for study median. Column selector for each of the following metrics:

- Initial IRB/EC Approval to Site Initiated (# Days)

- Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)

- Site Initiated to 1st Subject Enrolled (# Days)

Audience

- Region Manager

- Study Manager

Report Type

- View Selector (Line Graph)

Location

- Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-127 describes the columns in the Study Region vs. Study: Site Start Up KPIs analysis

Table A-127 Study Region vs. Study: Site Start Up KPIs (Report CDA-CO-1111)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

- Study Metrics

1st Site Initiated to 1st Subject Enrolled (# Days)

"- Study Metrics"."1st Site Initiated to 1st Subject Enrolled (# Days)"

- Study Region Metrics

1st Site Initiated to 1st Subject Enrolled (# Days)

MEDIAN("- Study Region Metrics"."1st Site Initiated to 1st Subject Enrolled (# Days)")

- Study Metrics

1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)

"- Study Metrics"."1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)"

- Study Region Metrics

1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)

MEDIAN("- Study Region Metrics"."1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)")

- Study Metrics

1st Initial IRB/EC Approval to 1st Site Initiated (# Days)

"- Study Metrics"."1st Initial IRB/EC Approval to 1st Site Initiated (# Days)"

- Study Region Metrics

1st Initial IRB/EC Approval to 1st Site Initiated (# Days)

MEDIAN("- Study Region Metrics"."1st Initial IRB/EC Approval to 1st Site Initiated (# Days)")

Study Regions with Red or Yellow Performance Flag - Data Management Detail View (Report CDA-CO-1200A)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

- Region Manager

Report Type

- Table

Location

- Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

Reports Referencing This Report

None

Column Descriptions

Table A-128 describes the columns in the Study Regions with Red or Yellow Performance Flag - Data Management Detail View analysis.

Table A-128 Study Regions with Red or Yellow Performance Flag - Data Management Detail View (Report CDA-CO-1200A)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Discrepancies (Queries)

# Open Discrepancies (Queries)

NA

Discrepancies (Queries)

# Total Discrepancies (Queries)

NA

Discrepancies (Queries)

# Days Discrepancy (Query) Open

NA

Received CRFs

# CRFs Awaiting Entry Completion

NA

Received CRFs

# eCRFs To Be Approved

NA

Received CRFs

# eCRFs To be Verified

NA

Received CRFs

# CRFs Soft Locked (Frozen)

NA

Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

NA

Received CRFs

# CRFs Hard Locked (Locked)

NA

Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

NA

Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

- Region Manager

Report Type

- Table

Location

- Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

Reports Referencing This Report

None

Column Descriptions

Table A-129 describes the columns in the Study Regions with Red or Yellow Performance Flag - Recruitment Detail View analysis.

Table A-129 Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region Metrics, Ratios

% Planned Subjects Randomized

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Screened Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Screened Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject 1st Visit Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject 1st Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject 1st Visit Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

- Region Manager

Report Type

- Table

Location

- Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

Reports Referencing This Report

None

Column Descriptions

Table A-130 describes the columns in the Study Regions with Red or Yellow Performance Flag - Retention Detail View analysis.

Table A-130 Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

- Region Manager

Report Type

- Table

Location

- Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

Reports Referencing This Report

None

Column Descriptions

Table A-131 describes the columns in the Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View analysis.

Table A-131 Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Counts

# Study-Sites Planned for Study-Region

NA

Study-Region Metrics, Counts

# Study-Sites Initiated

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Original Planned Dates

[Planned 1st IRB/EC Submission Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

NA

Study-Region Metrics, Actual Milestones

[1st IRB/EC Submission Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

NA

Study-Region Metrics, Actual Milestones

1st Initial IRB/EC Approval Date

NA

Study-Region, Original Planned Dates

[Planned 1st Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

NA

Study-Region Metrics, Actual Milestones

1st Site Initiated Date

NA

Study-Region, Original Planned Dates

[Planned Last Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Site Initiated Date]

NA

Study-Region Metrics, Actual

Latest Site Initiated Date

NA

Study-Region Metrics, Actual Milestones

[Last Site Initiated Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[1st Critical Document Package Completed Date]

NA

Study-Region, Original Planned Dates

[Planned Last Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Latest Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Last Critical Document Package Completed Date]

NA

Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

- Region Manager

Report Type

- Table

Location

- Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

Reports Referencing This Report

None

Column Descriptions

Table A-132 describes the columns in the Study Regions with Red or Yellow Performance Flag - Study Close Detail View analysis.

Table A-132 Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Received CRFs

# CRFs Awaiting Entry Completion

NA

Received CRFs

# eCRFs To Be Approved

NA

Received CRFs

# eCRFs To be Verified

NA

Received CRFs

# CRFs Soft Locked

NA

Received CRFs

% CRFs Soft Locked / Entry Complete

NA

Received CRFs

# CRFs Hard Locked

NA

Received CRFs

% CRFs Hard Locked / Entry Complete

NA

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study, Original Planned Dates

[Planned Clinical Study Report Date]

NA

Study, Latest Estimate Dates

[Planned LE Clinical Study Report Date]

NA

Study, Key Dates

[Clinical Study Report Date]

NA

Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

- Region Manager

Report Type

- Table

Location

- Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

Reports Referencing This Report

None

Column Descriptions

Table A-133 describes the columns in the Study Regions with Red or Yellow Performance Flag - Summary View analysis.

Table A-133 Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study

[Protocol Approved Date]

NA

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)

Lists the study-sites including key CRF and discrepancy (query) metrics as well as progress tracking for site data management. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Data Management View report.

Table A-134 Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Queries) Open

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)

Lists the study-sites including key monitoring metrics as well as progress tracking for site monitoring. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Monitoring View report.

Table A-135 Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Study-Site Metrics

Latest Site Visit Completed Date

"- Study-Site Metrics"."Latest Site Visit Completed Date"

- Study-Site Metrics

# Days Since Latest Site Visit

TRUNCATE("- Study-Site Metrics"."# Days Since Latest Site Visit",0)

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

Latest Site Visit Type

"- Study-Site Metrics"."Latest Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site recruitment. Includes study-site-health indicators for recruitment and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Recruitment Detail View report.

Table A-136 Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Randomized vs. Planned - Study-Site",2) as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site retention. Includes study-site-health indicators for retention and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Retention Detail View report.

Table A-137 Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Site Start Up Detail View report.

Table A-138 Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Document Metrics

# Documents Outstanding

"- Document Metrics"."# Documents Outstanding"

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for study close. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Study Close Detail View report.

Table A-139 Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment and retention. Includes study-site-health indicators for recruitment, retention, and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Summary View report.

Table A-140 Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

Lists all study-sites that have been initiated but have not yet enrolled a subject, including the time since initiation. This report indicates how poorly a study-site is performing with regard to enrolling the first subject post-initiation.

Audience

- Study Manager

- CRA

- Region Manager

Report Type

- Table

Location

- Study Overview dashboard, Non Performing Investigators page

- Study Region Overview dashboard, Non-Performing Investigators page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study Overview Dashboard

- Investigator Contact and Studies List (Report CDA-CO-202)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study Sites Initiated but Zero Enrolled report.

Table A-141 Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

Study-Site

Status

Study-Site.Study-Site Status

Study-Region

Region Name

Study-Region.Region Name

Site Initiated

Date

Study-Site.Site Initiated Date

Site Initiated

Days Since

Study-site Metrics.Days Since Initiation

NA

Navigate to Detail

NA

Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

Lists all study-sites that have been initiated but have only enrolled one subject, including the time since that subject was enrolled. This report indicates how poorly a study-site is performing with regard to enrolling more than one subject post-initiation.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Non Performing Investigators page

- Study Region Overview dashboard, Non-Performing Investigators page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study Overview Dashboard

- Investigator Contact and Studies List (Report CDA-CO-202)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study Sites Initiated, only One Subject Enrolled report.

Table A-142 Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

Study-Site

Status

Study-Site.Study-Site Status

Site Initiated

Actual

Study-Site.Site Initiated Date

Site Initiated

Days Since

Study-site Metrics.Days Since Initiation

- Study-Site Metrics

Latest Subject Enrolled Date

"- Study-site Metrics"."Latest Subject Enrolled Date"

- Study-Site Metrics

# Days Since Last Enrollment for Study-site

"- Study-site Metrics"."# Days Since Last Enrollment for Study-site"

NA

Navigate to Detail

NA

Study Team Member List (Report CDA-CO-111)

Lists all of the team members for a study.

Audience

- Study Manager

Report Type

- Table

Location

- Study Overview dashboard, Study Team page

Dimensions

- Study Team Member

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-143 describes the columns in the Study Team Member List analysis

Table A-143 Study Team Member List (Report CDA-CO-111)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study

Study

"Study"."Study"

Study Team Member

Full Name

"Study Team Member"."Full Name"

Study Team Member

Role

"Study Team Member"."Role"

Study Team Member

Start Date

"Study Team Member"."Start Date"

Study Team Member

End Date

"Study Team Member"."End Date"

Study Team Member

Email

"Study Team Member"."Email"

Study Team Member

Team Member Active

"Study Team Member"."Team Member Active"

Study-Region Information (Report CDA-CO-1113)

Displays a summary of identifying information for a study-region, including Region Name, Study #, and Study-Region Status.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- Narrative

Location

- Study-Region Overview dashboard, Overview Study-Site Milestones page

Dimensions

- Study, Study-Region

Supplementary Prompts

NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-144 describes the columns in the Study-Region Information analysis.

Table A-144 Study-Region Information (Report CDA-CO-1113)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

Study-Region List - Initiation Details (Report CDA-CO-306)

Lists study-regions in studies that have an approved protocol but no last subject enrolled date. Displays planned and actual number of sites, including how many are initiated, screening, and enrolling. Also displays key planned and actual milestones, as well as a milestone performance indicator. This report provides a list of ongoing study-regions that have not yet achieved 100% enrollment, including number of study-sites to reach certain achievements.

Audience

- Study Manager Region Manager

Report Type

- Table

Location

- Region Manager dashboard, Initiating and Recruiting Study Region page

Dimensions

- Study, Study-Region

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study Overview Dashboard

- Study-Region Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-145 describes the columns in the Study-Region List - Initiation Details analysis

Table A-145 Study-Region List - Initiation Details (Report CDA-CO-306)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

- Study Region Metrics

Milestone Indicator

"- Study Region Metrics"."Milestone Indicator"

- Study Region Metrics

Milestone Detail Reason

"- Study Region Metrics"."Milestone Detail Reason"

- Study Region Metrics

# Study-Sites Planned for Study-Region

CONCAT('Planned:' , cast("- Study Region Metrics"."# Study-Sites Planned for Study-Region" as char(40)))|| '

' || CONCAT('Actual:' , cast("- Study Region Metrics"."# Study-Sites Initiated" as char(40)))

- Study Region Metrics

# Study-Sites Initiated

CONCAT('Planned:' , cast("- Study Region Metrics"."# Study-Sites Planned for Study-Region" as char(40)))|| '

' || CONCAT('Actual:' , cast("- Study Region Metrics"."# Study-Sites Initiated" as char(40)))

- Study Region Metrics

# Sites Recruiting 1 or More Subjects

CONCAT('Actual:' , cast("- Study Region Metrics"."# Sites Recruiting 1 or More Subjects" as char(40)))

- Study Region Metrics

% of Planned Sites Initiated

CONCAT('Actual:',cast(ROUND("- Study Region Metrics"."% of Planned Sites Initiated", 2) as char(40)))

- Study-Region Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Region Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Region Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Region Metrics"."1st Site Initiated Date" , 'dd-Mon-yyyy'))

- Study-Region Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Region Metrics"."1st Site Initiated Date" , 'dd-Mon-yyyy'))

- Study Region Metrics

1st Site Initiated Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Region Metrics"."1st Site Initiated Date" , 'dd-Mon-yyyy'))

- Study-Region Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Region Metrics

Latest Site Initiated Date

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Region Metrics

[Last Site Initiated Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

Latest Site Initiated Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

Study-Region List - KPI Performance (Report CDA-CO-1108)

Provides a list of study-regions with target/actual KPIs and a KPI indicator. This report indicates whether a study-region is performing within target range for KPIs.

Audience

- Region Manager

Report Type

- Table

Location

None

Dimensions

- Study

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Region Overview Dashboard

- Study Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-146 describes the columns in the Performance Metrics Summary Narrative: Site Visit analysis

Table A-146 Study-Region List: KPI Performance (Report CDA-CO-1108)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics

% Sites Recruiting 0 Subjects

NA

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

NA

Study-Region Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

NA

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

NA

-

Median Site Visit Completed to Visit Report Completed

median("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

NA

-

Median Visit Report Completed to Visit Report Approved

median("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]"

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

NA

Study-Region List - Milestone Performance (Report CDA-CO-1109)

Provides a list of study-regions with planned, latest estimate and actual milestones, and a milestone indicator. This report indicates whether a study-region has exceeding planned dates for outstanding milestones.

Audience

- Region Manager

Report Type

- Table

Location

None

Dimensions

- Study-Region, Study

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study-Region Overview Dashboard

- Study Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-147 describes the columns in the Study-Region List: Milestone Performance analysis

Table A-147 Study-Region List: Milestone Performance (Report CDA-CO-1109)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

- Study Region Metrics

Milestone Flag

"- Study Region Metrics"."Milestone Flag"

- Study Region Metrics

Milestone Detail Reason

"- Study Region Metrics"."Milestone Detail Reason"

- Study-Region Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('Actual:',cast(MIN("- Study Region Metrics"."[1st IRB/EC Submission Date]") as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('Actual:',cast(MIN("- Study Region Metrics"."[1st IRB/EC Submission Date]") as char(40)))

- Study Region Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('Actual:',cast(MIN("- Study Region Metrics"."[1st IRB/EC Submission Date]") as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Region Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',Cast(MIN("- Study Region Metrics"."1st Site Initiated Date") as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',Cast(MIN("- Study Region Metrics"."1st Site Initiated Date") as char(40)))

- Study Region Metrics

1st Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',Cast(MIN("- Study Region Metrics"."1st Site Initiated Date") as char(40)))

- Study-Region Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Region Metrics

Latest Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Region Metrics

[Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Screened Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Screened Date" as char(40)))

- Study Region Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Screened Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Region Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Randomized Date" as char(40)))

- Study Region Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Enrolled Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Enrolled Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Enrolled Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Enrolled Date" as char(40)))

- Study Region Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Enrolled Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Enrolled Date" as char(40)))

- Study Region Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Enrolled Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Enrolled Date" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Randomized Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Randomized Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Randomized Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Randomized Date" as char(40)))

- Study Region Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Randomized Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Randomized Date" as char(40)))

- Study Region Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Randomized Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Randomized Date" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Last Visit Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Latest Visit Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Last Visit Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Latest Visit Date" as char(40)))

- Study Region Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Last Visit Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Latest Visit Date" as char(40)))

- Study Region Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Last Visit Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Latest Visit Date" as char(40)))

Study-Region List - Recruitment Details (Report CDA-CO-433)

Lists study-regions that have initiated their first site, have not achieved 100% enrollment, and have not enrolled their last subject. Displays planned and actual recruitment information and milestones, including recruitment and milestone performance indicators. This report provides a list of ongoing study-regions that have not yet achieved 100% enrollment, including recruitment information.

Audience

- Study Manager Region Manager

Report Type

- Table

Location

- Region Manager dashboard, Initiating and Recruiting Study Region page

Dimensions

- Study, Study-Region

Supplementary Prompts

- NA

Reports Referenced

You can navigate to the following reports from this report:

- Study-Region Team Member List (Report CDA-CO-1107)

- Study Overview Dashboard

- Study-Region Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

Table A-148 describes the columns in the Study-Region List - Recruitment Details analysis

Table A-148 Study-Region List - Recruitment Details (Report CDA-CO-433)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

Study-Region

Study

"Study-Region"."Study"

- Study Region Metrics

Retention Indicator

"- Study Region Metrics"."Retention Indicator"

- Study Region Metrics

Retention Detail Reason

"- Study Region Metrics"."Retention Detail Reason"

- Study Region Metrics

Milestone Indicator

"- Study Region Metrics"."Milestone Indicator"

- Study Region Metrics

Milestone Detail Reason

"- Study Region Metrics"."Milestone Detail Reason"

- Study-Region Targets

[Expected Screen Failure Rate]

CONCAT('Expected:' , MIN(cast(ROUND("- Study-Region Targets"."[Expected Screen Failure Rate]", 2) as char(40))))||'

'||CONCAT('Actual:' , cast(ROUND("- Study Region Metrics"."Screen Failure Rate", 2) as char(40)))

- Study Region Metrics

Screen Failure Rate

CONCAT('Expected:' , MIN(cast(ROUND("- Study-Region Targets"."[Expected Screen Failure Rate]", 2) as char(40))))||'

'||CONCAT('Actual:' , cast(ROUND("- Study Region Metrics"."Screen Failure Rate", 2) as char(40)))

- Study Region Metrics

% Enrolled to Total Planned at Study Region

"- Study Region Metrics"."% Enrolled to Total Planned at Study Region"

- Study Region Metrics

% Planned Subjects Randomized

"- Study Region Metrics"."% Planned Subjects Randomized"

- Study-Region Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:',cast(MIN("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:',cast(MIN("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:',cast(MIN("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Region Metrics

1st Site Initiated Date

"- Study Region Metrics"."1st Site Initiated Date"

- Study Metrics

% Planned Subjects Enrolled (Study)

"- Study Metrics"."% Planned Subjects Enrolled (Study)"

- Study Metrics

[Last Subject Enrolled Date]

"- Study Metrics"."[Last Subject Enrolled Date]"

Study-Region List and Recruitment Counts (Report CDA-CO-404)

Lists all study regions and recruitment counts. This report indicates how well each region is progressing toward recruitment goals.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Recruitment Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Region List and Recruitment Counts report.

Table A-149 Study-Region List and Recruitment Counts (Report CDA-CO-404)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study Region

Name

Study-Site.Study Region

Study Region

Status

Study-Site.Study Region Status

# Subjects

Planned for Region

Region Metrics.# Subjects Planned for Region

# Subjects

Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

# Subjects

Screened

Study-site Metrics.# Screened

# Subjects

Screen Failure

Study-site Metrics.# Screen Failure

# Subjects

Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

# Subjects

Randomized

Study-site Metrics.# Randomized

% to Plan

Site Enrollment

Study-site Metrics.% of Planned Site Enrollment Completed

Study-Region Team Member List (Report CDA-CO-1107)

Lists all of the team members for a study-region.

Audience

- Region Manager

Report Type

- Table

Location

- Study-Region Overview dashboard, Study-Region Team page

Dimensions

- Study-Region Team Member

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

- Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

- Study-Region List - KPI Performance (Report CDA-CO-1108)

- Study-Region List - Milestone Performance (Report CDA-CO-1109)

- Study-Region List - Initiation Details (Report CDA-CO-306)

- Study-Region List - Recruitment Details (Report CDA-CO-433)

Column Descriptions

Table A-150 describes the columns in the Study-Region Team Member List analysis.

Table A-150 Study-Region Team Member List (Report CDA-CO-1107)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region Team Member

Full Name

"Study-Region Team Member"."Full Name"

Study-Region Team Member

Role

"Study-Region Team Member"."Role"

Study-Region Team Member

Start Date

"Study-Region Team Member"."Start Date"

Study-Region Team Member

End Date

"Study-Region Team Member"."End Date"

Study-Region Team Member

Email

"Study-Region Team Member"."Email"

Study-Region Team Member

Team Member Active

"Study-Region Team Member"."Team Member Active"

Study-Site Enrollment Progress Gauge (Report CDA-CO-455)

Displays a gauge showing how many subjects have been enrolled in the study-site compared to the number of subjects planned for the study-site.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study-Site Overview dashboard, Risk Profile page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Study-Site Information (Report CDA-CO-206)

Displays a summary of identifying information for a study-site, including Study #, Program, Study-Site ID, Principal Investigator and Study-Site Status.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Information report.

Table A-151 Study-Site Information (Report CDA-CO-206)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Program

Study-Site.Program

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Name

Study-Site.Site Name

NA

CRA

Study-Site.CRA

NA

Status

Study-Site.Study-Site Status

NA

Study Region

Study-Site.Study Region

Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

Lists study-sites grouped by those with no subjects enrolled and those with 1 or more subjects enrolled. This report indicates which study-sites are performing better than others.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Table

Location

- Study Overview dashboard, Site Performance page

- Study-Region Overview dashboard, Site Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site List by Recruitment Performance Group report.

Table A-152 Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

Study-Site

Study

"Study-Site"."Study"

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Name

Study-Site.Site Name

NA

Study-Site Status

Study-Site.Study-Site Status

NA

CRA

Study-Site.CRA

NA

# Enrolled

- Study-site Metrics.# Subjects Enrolled

NA

% of Planned Site Enrollment Completed

- Study-site Metrics.% of Planned Site Enrollment Completed

NA

# Days Since Last Enrollment for Study-site

- Study-site Metrics.# Days Since Last Enrollment for Study-site

NA

Navigate to Detail

NA

Study-Site List with Indicators - Data Management View (Report CDA-CO-207A)

Lists study-sites including key CRF and discrepancy (query) metrics as well as progress tracking for data management. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Region Overview dashboard, Study-Site Milestones page

- CRA, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study List - Initiation Details (Report CDA-CO-305)

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Data Management View report.

Table A-153 Study-Site List with Indicators - Data Management View (Report CDA-CO-207A)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Query) Open

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study-Site List with Indicators - Monitoring View (Report CDA-CO-207B)

Lists study-sites including key monitoring metrics as well as progress tracking for site monitoring. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Region Overview dashboard, Study-Site Milestones page

- CRA, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study List - Initiation Details (Report CDA-CO-305)

Column Descriptions

The table describes the columns in the Study-Site List - Monitoring View with Indicators report.

Table A-154 Study-Site List with Indicators - Monitoring View (Report CDA-CO-207B)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

# Days Since Latest Site Visit

TRUNCATE("- Study-Site Metrics"."# Days Since Latest Site Visit",0)

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Study-Site Metrics

Latest Site Visit Completed Date

"- Study-Site Metrics"."Latest Site Visit Completed Date"

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

Latest Site Visit Type

"- Study-Site Metrics"."Latest Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

Study-Site List with Indicators - Recruitment Detail View (Report CDA-CO-207C)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site recruitment. Includes study-site-health indicators for recruitment and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Region Overview dashboard, Study-Site Milestones page

- CRA, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study List - Initiation Details (Report CDA-CO-305)

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Recruitment Detail View report.

Table A-155 Study-Site List with Indicators - Recruitment Detail View (Report CDA-CO-207C)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Randomized vs. Planned - Study-Site",2) as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

Study-Site List with Indicators - Retention Detail View (Report CDA-CO-207D)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site retention. Includes study-site-health indicators for retention, milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Region Overview dashboard, Study-Site Milestones page

- CRA, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study List - Initiation Details (Report CDA-CO-305)

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Retention Detail View report.

Table A-156 Study-Site List with Indicators - Retention Detail View (Report CDA-CO-207D)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

Study-Site List with Indicators - Site Start Up Detail View (Report CDA-CO-207E)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Region Overview dashboard, Study-Site Milestones page

- CRA, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study List - Initiation Details (Report CDA-CO-305)

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Site Start Up Detail View report.

Table A-157 Study-Site List with Indicators - Site Start Up Detail View (Report CDA-CO-207E)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Document Metrics

# Documents Outstanding

"- Document Metrics"."# Documents Outstanding"

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

Study-Site List with Indicators - Study Close Detail View (Report CDA-CO-207F)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for study close. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Region Overview dashboard, Study-Site Milestones page

- CRA, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study List - Initiation Details (Report CDA-CO-305)

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Study Close Detail View report.

Table A-158 Study-Site List with Indicators - Study Close Detail View (Report CDA-CO-207F)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

Study-Site List with Indicators - Summary View (Report CDA-CO-207G)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, and retention. Includes study-site-health indicators for recruitment, retention and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study Region Overview dashboard, Study-Site Milestones page

- CRA, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Overview Dashboard

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Detailed Study Milestones Report (Report CDA-CO-102)

- Study List - Initiation Details (Report CDA-CO-305)

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Summary View report.

Table A-159 Study-Site List with Indicators - Summary View (Report CDA-CO-207G)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

Lists study-sites including key monitoring metrics as well as progress tracking for site monitoring. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Study-Site Milestones page

- Study Region Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Monitoring View report.

Table A-160 Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

Latest Site Visit Completed Date

"- Study-Site Metrics"."Latest Site Visit Completed Date"

- Study-Site Metrics

Latest Site Visit Type

"- Study-Site Metrics"."Latest Site Visit Type"

- Study-Site Metrics

# Days Since Latest Site Visit

TRUNCATE("- Study-Site Metrics"."# Days Since Latest Site Visit",0)

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To BeApproved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To beVerified"

Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site recruitment. Includes study-site-health indicators for recruitment and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Study-Site Milestones page

- Study Region Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Recruitment Detail View report.

Table A-161 Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Randomized vs. Planned - Study-Site",2) as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site retention. Includes study-site-health indicators for retention and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Study-Site Milestones page

- Study Region Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Retention Detail View report.

Table A-162 Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Study-Site Milestones page

- Study Region Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View report.

Table A-163 Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Document Metrics

# Documents Outstanding

"- Document Metrics"."# Documents Outstanding"

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for study close. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Study-Site Milestones page

- Study Region Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Study Close Detail View report.

Table A-164 Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft Locked

"- Received CRFs"."# CRFs Soft Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard Locked

"- Received CRFs"."# CRFs Hard Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment and retention. Includes study-site-health indicators for recruitment, retention and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Study-Site Milestones page

- Study Region Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Summary View report.

Table A-165 Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment and retention. Includes study-site-health indicators for recruitment, retention and milestones. This report indicates which study-sites require action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Study-Site Milestones page

- Study Region Overview dashboard, Study-Site Milestones page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Data Management View report.

Table A-166 Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Discrepancies (Queries

# Open Discrepancies (Queries

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries

# Total Discrepancies (Queries

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/ "-Discrepancies"."# TotalDiscrepancies")

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To beVerified"

- Received CRFs

# CRFs Soft Locked (Frozen)

"- Received CRFs"."# CRFs Soft Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard Locked (Locked)

"- Received CRFs"."# CRFs Hard Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study-Site Milestones with Indicators (Single Study-Site) - Data Management View (Report CDA-CO-203A)

Lists (for a study-site) key milestone dates and enrollment, enrollment progress, and study-site-health indicator. This report indicates whether a study-site requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Data Management View report.

Table A-167 Study-Site Milestones with Indicators (Single Study-Site) - Data Management View (Report CDA-CO-203A)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Query) Open

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)

Lists (for a study-site) key monitoring dates as well as progress tracking for site monitoring. This report indicates whether a study-site requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View report.

Table A-168 Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

Latest Site Visit Completed Date

"- Study-Site Metrics"."Latest Site Visit Completed Date"

- Study-Site Metrics

Latest Site Visit Type

"- Study-Site Metrics"."Latest Site Visit Type"

- Study-Site Metrics

# Days Since Latest Site Visit

TRUNCATE("- Study-Site Metrics"."# Days Since Latest Site Visit",0)

- Study-Site Metrics

Median # Days Between Site Visits

"- Study-Site Metrics"."Median # Days Between Site Visits"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View (Report CDA-CO-203C)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for site recruitment. Includes study-site-health indicators for recruitment and milestones. This report indicates whether a study-site requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View report.

Table A-169 Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View (Report CDA-CO-203C)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Randomized vs. Planned - Study-Site",2) as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View (Report CDA-CO-203D)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for site retention. Includes study-site-health indicators for retention and milestones. This report indicates whether a study-site requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View report.

Table A-170 Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View (Report CDA-CO-203D)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View (Report CDA-CO-203E)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up. Includes study-site-health indicator for milestones. This report indicates whether a study-site requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View report.

Table A-171 Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View (Report CDA-CO-203E)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Document Metrics

# Documents Outstanding

"- Document Metrics"."# Documents Outstanding"

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date"as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date"as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View (Report CDA-CO-203F)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for study close. Includes study-site-health indicator for milestones. This report indicates whether a study-site requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View report.

Table A-172 Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View (Report CDA-CO-203F)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, and study close. Includes study-site-health indicators for recruitment, retention and milestones. This report indicates whether a study-site requires action, and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Summary View report.

Table A-173 Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

Study-Site Missed Dose Details (Report CDA-CO-215)

Lists the number of times a Study-Site has missed dosing subjects, usually due to lack of supply. Includes the date the dose was missed, the date entered, and any comments about the missed dose.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Not included on a dashboard

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Study-Site Missed Dose Tile (Report CDA-CO-220)

Study-Site Missed Dose Tile (Report CDA-CO-220)

Lists the number of times a Study-Site has missed dosing subjects, usually due to lack of supply. Includes the date the dose was missed, the date entered and any comments about the missed dose.

Audience

- Study Manager

- CRA

Report Type

- Tile

Location

- Study-Site Overview dashboard, Risk Profile page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Missed Dose Details (Report CDA-CO-215)

Reports Referencing This Report

None

Study-Site RACT (Report CDA-CO-856)

Displays the RACT (Risk Assessment Categorization Tool) for a Study-Site. This analysis lists all the questions on the RACT with the scores for impact, probability, and detectability. it also lists any considerations, mitigations, or comments.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Not located on a dashboard

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Study-Site RACT Score Tile (Report CDA-CO-859)

Study-Site RACT by Category (Report CDA-CO-857)

Displays the RACT (Risk Assessment Categorization Tool) score, broken out by category for a Study-Site.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Not included on a dashboard

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site RACT (Report CDA-CO-856)

Reports Referencing This Report

- Study-Site RACT Score Tile (Report CDA-CO-859)

Study-Site RACT Score Tile (Report CDA-CO-859)

Displays the tile with the RACT (Risk Assessment Categorization Tool) score for a Study-Site.

Audience

- Study Manager

- CRA

Report Type

- Tile

Location

- Study-Site Overview dashboard, Risk Profile page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site RACT (Report CDA-CO-856)

- Study-Site RACT by Category (Report CDA-CO-857)

Reports Referencing This Report

None

Study-Site Risk Indicator Map (Report CDA-CO-1210)

Map of multiple risk indicators for the study-sites in the study.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Map with Table

Location

- Study Overview dashboard, Risk Profile page

Dimensions

- Study-Site

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Study-Site Subject Recruitment Narrative (Report CDA-CO-405)

Displays a summary of recruitment information for a study-site. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study-site.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Subject Recruitment Narrative report.

Table A-174 Study-Site Subject Recruitment Narrative (Report CDA-CO-405)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

For Study:

# Planned

Study Metrics.# Subjects Planned for Study

For Study-Site:

# Planned

Study-site Metrics.# Subjects Planned for Study-Site

For Study-Site:

# Screened

Study-site Metrics.# Screened

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

% of Planned Site Enrollment Completed

Study-site Metrics.% of Planned Site Enrollment Completed

NA

% of Total Enrolled in Study

Study-site Metrics.% of Total Enrolled in Study

NA

# Randomized

Study-site Metrics.# Randomized

NA

% Randomized vs. Planned - Study

Study Metrics.% Randomized vs. Planned - Study

NA

% of Total Randomized in Study

Study-site Metrics.% of Total Randomized in Study

Study-Site Subject Retention (Report CDA-CO-500)

Displays a summary of retention information for a study-site. This report indicates planned recruitment vs. actual retention information for a single study-site.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study-Site Overview dashboard, Study-Site Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Subject Retention report.

Table A-175 Study-Site Subject Retention (Report CDA-CO-500)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

For Study:

# Planned

Study Metrics.# Subjects Planned for Study

For Study:

% Early Terminated

Study-site Metrics.% Subjects Early Terminated for Study

For Study-Site:

# Planned

Study-site Metrics.# Subjects Planned for Study-Site

For Study-Site:

# Enrolled (to date)

Study-Site Metrics.# Enrolled

For Study-Site:

# Subjects - Current Status Enrolled

Study-site Metrics.# Subjects - Current Status Enrolled

NA

# Completed

Study-site Metrics.# Subjects who have completed Study

NA

# Early Terminations

Study-site Metrics.# Early Terminations

NA

% Early Terminated

Study-site Metrics.% Subjects Early Terminated for Study-site

Study-Site Team Member List (Report CDA-CO-201)

Lists all of the team members for a study-site.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- Study-Site Overview dashboard, Study-Site Team page

Dimensions

- Study-Site Team Member

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

- Uninitiated Sites (Report CDA-CO-304)

- Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

Column Descriptions

The table describes the columns in the Study-Site Team Member List report.

Table A-176 Study-Site Team Member List (Report CDA-CO-201)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Last Name

Study-Site Team Member.Last Name

NA

First Name

Study-Site Team Member.First Name

NA

Role

Study-Site Team Member.Role

NA

Start Date

Study-Site Team Member.Start Date

NA

End Date

Study-Site Team Member.End Date

NA

Email

Study-Site Team Member.Email

NA

Team Member Active

Study-Site Team Member.Team Member Active

NA

Team Member Comment

Study-Site Team Member.Team Member Comment

Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Lists study-sites with an indicator of study-site health, where the indicator is red or yellow. This report indicates which study-sites require action and why.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, CRA Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following report from this report:

- Study-Site Team Member List (Report CDA-CO-201)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Sites with Red or Yellow Performance Flag report.

Table A-177 Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Site

Program

Study-Site.Program

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention Detail Reason

"- Study-Site Metrics"."Retention Detail Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

Subject Enrollment by Region (Report CDA-CO-414)

Shows the distribution of subject enrollment by region. This report indicates which regions are contributing the most to recruitment.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Study Region Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Enrollment by Region report.

Table A-178 Subject Enrollment by Region (Report CDA-CO-414)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

# Enrolled

- Study-site Metrics.# Subjects Enrolled

Subject Recruitment and Discontinuation Study Risk Gauges (Report CDA-CO-440)

Displays gauges for subject recruitment and discontinuation risk indicators (Screen Failure Rate and Withdrawal Rate) at the study level.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study Overview dashboard, Risk Profile page

Dimensions

- Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Subject Recruitment and Discontinuation Study-Site Risk Gauges (Report CDA-CO-450)

Displays gauges for subject recruitment and discontinuation risk indicators (Screen Failure Rate and Withdrawal Rate) at the study-site level.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Gauge

Location

- Study-Site Overview dashboard, Risk Profile page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Subject Recruitment (Report CDA-CO-419)

Displays a summary of recruitment information for a study. This report indicates planned recruitment versus actual screening, enrollment and randomization information for a single study.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study Overview dashboard, Study Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Recruitment report.

Table A-179 Subject Recruitment (Report CDA-CO-419)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

# Planned

Study Metrics.# Subjects Planned for Study

NA

# Screened

Study-site Metrics.# Screened

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Randomized

Study-site Metrics.# Randomized

NA

% Enrolled / Planned

Study Metrics.% Enrolled / Planned in Study

NA

% Randomized / Planned

Study Metrics.% Randomized vs. Planned Study

Subject Recruitment (Study Region) (Report CDA-CO-1114)

Displays a summary of recruitment information for a study-region. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study-region.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- Narrative

Location

- Study-Region Overview dashboard, Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-180 describes the columns in the Subject Recruitment (Study Region) analysis

Table A-180 Subject Recruitment (Study Region) (Report CDA-CO-1114)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

- Study Metrics

# Subjects Planned for Study

"- Study Metrics"."# Subjects Planned for Study"

- Study Region Metrics

# Subjects Planned for Study-Region

"- Study Region Metrics"."# Subjects Planned for Study-Region"

- Study-Site Metrics

# Screened

"- Study-site Metrics"."# Screened"

- Study-Site Metrics

# Enrolled

"- Study-site Metrics"."# Enrolled"

- Study Region Metrics

% Enrolled to Total Planned at Study Region

"- Study Region Metrics"."% Enrolled to Total Planned at Study Region"

- Study-Site Metrics

% of Total Enrolled in Study

"- Study-site Metrics"."% of Total Enrolled in Study"

- Study-Site Metrics

# Randomized

"- Study-site Metrics"."# Randomized"

- Study Region Metrics

% Planned Subjects Randomized

"- Study Region Metrics"."% Planned Subjects Randomized"

- Study-Site Metrics

% of Total Randomized in Study

"- Study-site Metrics"."% of Total Randomized in Study"

Study-Region

Study

"Study-Region"."Study"

Subject Retention (Report CDA-CO-504)

Displays a summary of retention information for a study. This report indicates planned recruitment vs. actual retention information for a single study.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study Overview dashboard, Study Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Retention report.

Table A-181 Subject Retention (Report CDA-CO-504)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

# Planned for Study

Study Metrics.# Subjects Planned for Study

NA

# Current Active

Study-site Metrics.# Current Active Subjects

NA

# Completed Study

Study-site Metrics.# Subjects who have completed Study

NA

# Early Terminations

Study-site Metrics.# Early Terminations

NA

% Early Term / Planned

CAST(- Study-site Metrics.# Early Terminations*100 /- Study Metrics.# Subjects Planned for Study AS FLOAT)

Subject Retention (Study Level) (Report CDA-CO-503)

Displays a summary of retention information for a study. This report indicates planned recruitment vs. actual retention information for a single study.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study Overview dashboard, Retention Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Retention (Study Level) report.

Table A-182 Subject Retention (Study Level) (Report CDA-CO-503)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

# Planned

Study Metrics.# Subjects Planned for Study

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Completed Study

Study-site Metrics.# Subjects who have completed Study

NA

# Early Terminations

Study-site Metrics.# Early Terminations

NA

# Early Term / Planned

Study-site Metrics.# Early Terminations/- Study Metrics.# Subjects Planned for Study

Subject Retention (Study Region) (Report CDA-CO-1115)

Displays a summary of retention information for a study-region. This report indicates planned recruitment vs. actual retention information for a single study-region.

Audience

- Region Manager

- Study Manager

- Executive Manager

- Program Manager

Report Type

- Narrative

Location

- Study-Region Overview dashboard, Overview Retention Overview page

Dimensions

- Study-Region

Supplementary Prompts

- NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-183 describes the columns in the Subject Retention (Study Region) analysis.

Table A-183 Subject Retention (Study Region) (Report CDA-CO-1115)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

Study-Region

Study

"Study-Region"."Study"

- Study Metrics

# Subjects Planned for Study

"- Study Metrics"."# Subjects Planned for Study"

- Study Metrics

% Subjects Early Terminated for Study

"- Study Metrics"."% Subjects Early Terminated for Study"

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

- Study Region Metrics

# Subjects Planned for Study-Region

"- Study Region Metrics"."# Subjects Planned for Study-Region"

- Study-Site Metrics

# Enrolled

"- Study-Site Metrics"."# Enrolled"

- Study-Site Metrics

# Subjects - Current Status Enrolled

"- Study-Site Metrics"."# Subjects - Current Status Enrolled"

- Study-Site Metrics

# Subjects - Current Status Completed

"- Study-Site Metrics"."# Subjects - Current Status Completed"

- Study-Site Metrics

# Early Terminations

"- Study-Site Metrics"."# Early Terminations"

- Study Region Metrics

% Subjects Early Terminated for Study-Region

"- Study Region Metrics"."% Subjects Early Terminated for Study-Region"

Subject Retention (Study-Site Level) (Report CDA-CO-502)

Displays a summary of retention information for a study-site. This report indicates planned recruitment vs. actual retention information for a single study-site.

Audience

- Study Manager

- CRA

Report Type

- Narrative

Location

- Study-Site Overview dashboard, Retention Overview page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Retention (Study-Site Level) report.

Table A-184 Subject Retention (Study-Site Level) (Report CDA-CO-502)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

For Study:

# Planned

Study Metrics.# Subjects Planned for Study

For Study-Site:

# Planned

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Completed

Study-site Metrics.# Subjects who have completed Study

NA

# Early Terminated

Study-site Metrics.# Early Terminations

NA

% Early Terminated

Study-site Metrics.# Early Terminations/- Study Metrics.# Subjects Planned for Study

Subject Retention Over Time (Study Level) (Report CDA-CO-501)

Shows cumulative subjects completed and early terminated over time, compared to static planned subjects enrolled (50%, 75%, 90% and 100%) for a study. This report indicates the progress of subject retention and early termination.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Retention Overview page

Dimensions

- Study-Site

- All-Purpose Date

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Retention Over Time (Study Level) report.

Table A-185 Subject Retention Over Time (Study Level) (Report CDA-CO-501)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

1

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END))

NA

0.9

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .9)

NA

0.75

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .75)

NA

0.5

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .5)

NA

# Subjects Completed

RSUM(- Study-site Metrics.# Subjects who have completed Study)

Subject Retention Over Time (Study-Site Level) (Report CDA-CO-510)

Displays cumulative subjects off study over time, compared to static planned subjects enrolled (50%, 75%, 90% and 100%) for a study-site. This report indicates the progress of subject retention.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study-Site Overview dashboard, Retention Overview page

Dimensions

- Study-Site All-Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

- Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

Column Descriptions

The table describes the columns in the Subject Retention Over Time (Study-Site Level) report

Table A-186 Subject Retention Over Time (Study-Site Level) (Report CDA-CO-510)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

1

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END))

NA

0.9

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .9)

NA

0.75

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .75)

NA

0.5

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .5)

NA

# Subjects Completed

RSUM(- Study-site Metrics.# Subjects who have completed Study)

Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

Shows cumulative subjects completed and early terminated over time, compared to static planned subjects enrolled (50%, 75%, 90% and 100%) for a study. This report indicates the progress of subject retention and early termination.

Audience

- Region Manager

- Study Manager

- CRA

Report Type

- View Selector (2 Charts, Table)

Location

- Study-Region Overview dashboard, Overview Retention Overview page

Dimensions

- Study-Region

Supplementary Prompts

- Year and Month Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-187 describes the columns in the Subject Retention Over Time Chart (Study-Region Level) analysis

Table A-187 Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Month

"- All Purpose Date"."Year and Month"

Study-Region

Study

"Study-Region"."Study"

Study-Region

Region Name

"Study-Region"."Region Name"

- Study-Site Metrics

# Subjects who have completed Study

IFNULL(RSUM("- Study-Site Metrics"."# Subjects who have completed Study"), 0) + @{pv_subjects_completed_stdy_reg}

- Study-Site Metrics

# Early Terminations

IFNULL(RSUM("- Study-Site Metrics"."# Early Terminations"), 0) + @{pv_early_term_stdy_region}

Subjects Enrolled per Month, Over Time (Report CDA-CO-403)

Displays the number of subjects enrolled per month. This report indicates the pattern of enrollment over time at a study-site.

Audience

- Study Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study-Site Overview dashboard, Monitoring Metrics page

Dimensions

- Study-Site

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subjects Enrolled per Month, Over Time report

Table A-188 Subjects Enrolled per Month, Over Time (Report CDA-CO-403)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

Year and Month

All Purpose Date.Year and Month

Subjects who Failed Screening (Report CDA-CO-428)

Lists (by program, study, and site) all subjects who have failed screening, including screen failure reason and subject comments. This report indicates which screen failure reasons account for the most screen failures.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

None

Dimensions

- Study-Site

- Subject

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

- Screen Failure Reason (Report CDA-CO-425)

- Screen Failure Reason by Site (Report CDA-CO-300)

- Screen Failure Reason (Report CDA-CO-420)

Column Descriptions

The table describes the columns in the Subjects who Failed Screening report.

Table A-189 Subjects who Failed Screening (Report CDA-CO-428)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Study-Site

Study, Site, and Investigator

Study-Site.Study, Site, and Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Subject

Screening #

Subject.Screening #

Subject

Screen Failure Reason

Subject.Screen Failure Reason

Subject

Subject Comments

Subject.Subject Comments

NA

Subject Status

Subject Metrics.Subject Status

NA

Status Comment

Subject Metrics.Status Comment

Subjects Withdrawn List (Report CDA-CO-509)

Lists (by program, study, region, and site) all subjects who terminated the study early, including withdrawn reason and subject comments. This report indicates which withdrawn reasons account for the most early terminations.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

None

Dimensions

- Study-Site

- Subject

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

- Withdrawn Reason (Report CDA-CO-505)

- Withdrawn Reason Overview (Report CDA-CO-508)

Column Descriptions

The table describes the columns in the Subjects Withdrawn List report.

Table A-190 Subjects Withdrawn List (Report CDA-CO-509)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

Product

Product Name

Study-Site.Product

Region

Region Status

Study-Site.Study Region Status

Study

Study Status

Study-Site.Study Status

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Program

Study-Site.Program

Study-Site

Site Name

Study-Site.Site Name

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Subject

Enrollment Id

Subject.Enrollment Id

Subject

Withdrawn Reason

Subject.Withdrawn Reason

Subject

Subject Comments

Subject.Subject Comments

NA

Subject Status

Subject Metrics.Subject Status

NA

Status Comment

Subject Metrics.Status Comment

Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

Identifies specific subjects who have eCRFs awaiting processing. This report indicates those subjects which require processing, and the number of eCRFs to be processed. This information can be used as a summary work log to take to a site visit to drive activity.

Audience

- Data Manager

Report Type

- Table

Location

- Data Manager - EDC dashboard, Study Processing Summary page

Dimensions

- Study-Site

- Subject

Supplementary Prompts

- Study

- Study-Site

Reports Referenced

You can navigate to the following reports from this report:

- Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

Reports Referencing This Report

The following reports reference this report:

- Key EDC Processing Volumes (Report CDA-DM-305)

Column Descriptions

The table describes the columns in the Summary of Subjects Awaiting EDC Processing report.

Table A-191 Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

NA

NA

Study-Site.Study Name

Subject

Subject ID

Subject.Subject ID

# eCRFs

Entry Complete

Received CRFs.# eCRFs Entry Complete

# eCRFs

Not Verified

Received CRFs.# eCRFs Never Verified

# eCRFs

Awaiting Re-Verification

Received CRFs.# eCRFs Awaiting Re-Verification

# eCRFs

Not Approved

Received CRFs.# eCRFs Not Approved

# eCRFs

Awaiting Re-Approval

Received CRFs.# eCRFs Awaiting Re-Approval

Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

Identifies specific CRFs, and the process steps they are awaiting. This report lists, for a subject, the pages which are awaiting processing. This information can be used to drive activity.

Audience

- Data Entry Manager

- Data Manager

Report Type

- Table

Location

- Data Manager - Paper dashboard, Study Processing Summary page

Dimensions

- Study-Site

- Subject

Supplementary Prompts

- Study

- Study-Site

Reports Referenced

You can navigate to the following reports from this report:

- Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

Reports Referencing This Report

The following reports reference this report:

- Key Paper processing volumes (Report CDA-DM-405)

Column Descriptions

The table describes the columns in the Summary of Subjects Awaiting Paper Processing report

Table A-192 Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

NA

NA

Study-Site.Study Name

Subject

Subject ID

Subject.Subject ID

# CRFs

Present

Received CRFs.# pCRFs Present

# CRFs

Awaiting First Entry Completion

Received CRFs.# pCRFs Awaiting Pass 1 Entry Completion

# CRFs

Awaiting Second Entry Completion

Received CRFs.# pCRFs Awaiting Pass 2 Entry Completion

Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

Lists the top investigators based on % planned enrollment completed for study-sites that are either completely enrolled or study-sites that are closed. This report indicates who the top performing investigators in the study are.

Audience

- Executive

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Manager dashboard, Top Investigators page

- CRA dashboard, Top Investigators page

- Study Overview dashboard, Top Investigators page

- Executive dashboard, Top Investigators page

- Region Manager dashboard, Top Investigators page

- Study-Region Overview dashboard, Top Investigators page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Top Investigators Compared to All Investigators for Study, Total Enrollment report.

Table A-193 Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Study-Site ID #

TBD

NA

Principal Investigator

TBD

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

Rank

TBD

Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

Lists the top investigators based on % planned enrollment completed for study-sites that are either completely enrolled or study-sites that are closed. This report indicates who the top performing investigators in the study are.

Audience

- Executive

- Study Manager

- Region Manager

- CRA

Report Type

- Table

Location

- Study Manager dashboard, Top Investigators page

- CRA dashboard, Top Investigators page

- Study Overview dashboard, Top Investigators page

- Executive dashboard, Top Investigators page

- Region Manager dashboard, Top Investigators page

- Study-Region Overview dashboard, Top Investigators page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Investigator Contact and Studies List (Report CDA-CO-202)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Top Investigators, % Planned Enrollment Completed report.

Table A-194 Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

% Enrolled to Total Planned at Study-Site

Study-site Metrics.% Enrolled to Total Planned at Study-Site

NA

Rank

rank (- Study-site Metrics.% Enrolled to Total Planned at Study-Site)

Top Investigators, Total Enrollment (Report CDA-CO-701)

Lists the top investigators based on total number of subjects enrolled for study-sites that are either completely enrolled or study-sites that are closed. This report indicates who the top performing investigators in the study are.

Audience

- Executive

- Study Manager

- Region Manager

- CRA

Report Type

- Table

Location

- Study Manager dashboard, Top Investigators page

- CRA dashboard, Top Investigators page

- Study Overview dashboard, Top Investigators page

- Executive dashboard, Top Investigators page

- Region Manager dashboard, Top Investigators page

- Study-Region Overview dashboard, Top Investigators page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Investigator Contact and Studies List (Report CDA-CO-202)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Top Investigators, Total Enrollment report.

Table A-195 Top Investigators, Total Enrollment (Report CDA-CO-701)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

# Enrolled

- Study-site Metrics.# Subjects Enrolled

NA

Rank

Rank (- Study-site Metrics.# Subjects Enrolled)

Total Subject Enrollment by Region (Report CDA-CO-410)

Shows cumulative actual enrollment by region. This report indicates which regions are contributing the most to recruitment.

Audience

- Study Manager CRA

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Study Region Performance page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Site Detail (Report CDA-CO-209)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Total Subject Enrollment by Region report.

Table A-196 Total Subject Enrollment by Region (Report CDA-CO-410)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

Site Name

OCDA.Study-Site.Site Name

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

Uninitiated Sites (Report CDA-CO-304)

Lists study-sites that have not yet been initiated, including whether they've received IRB/EC approval and number of outstanding documents. This report indicates which study-sites are awaiting initiation and possible reasons for delay.

Audience

- Study Manager

- CRA

Report Type

- Table

Location

- CRA dashboard, Initiating and Recruiting Study-Sites page

Dimensions

- Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Study-Site Team Member List (Report CDA-CO-201)

- Outstanding Documents List (Report CDA-CO-602)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Uninitiated Sites report.

Table A-197 Uninitiated Sites (Report CDA-CO-304)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

Study-Site

Study Region

"Study-Site"."Study Region"

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Name

Study-Site.Site Name

NA

Study-Site Status

Study-Site.Study-Site Status

NA

Initial IRB/EC Approval Date

Study-Site.Initial IRB/EC Approval Date

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

Study-Site

Site Name

"Study-Site"."Site Name"

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

NA

# Documents Outstanding

Document Metrics.# Documents Outstanding

NA

Navigate to Detail

NA

Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

Shows the number of site visits and number of subjects enrolled over time. This report indicates the relationship between subject enrollment and the number of site visits.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, Table (optional)

Location

- Study Overview dashboard, Monitoring Metrics page

- Study Overview dashboard, Monitoring Metrics page

- Region Manager dashboard, Monitoring Metrics page

Dimensions

- All Purpose Date

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Visit Frequency Compared to Subject Enrollment report.

Table A-198 Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

Table Heading

Column Heading

Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Site Visits

Study-site Metrics.# Site Visits

Withdrawn Reason (Report CDA-CO-505)

Displays (by withdrawn reason) the number of subjects who terminated early. This report indicates which withdrawn reasons account for the most early terminations.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, table (optional)

Location

- Study Overview dashboard, Retention Overview page

- Study-Site Overview dashboard, Retention Overview page

- Study-Region Overview dashboard, Retention Overview page

Dimensions

- Subject

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Subjects Withdrawn List (Report CDA-CO-509)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Withdrawn Reason report.

Table A-199 Withdrawn Reason (Report CDA-CO-505)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

Count of Early Terms

COUNT(CASE WHEN - Subject Metrics.Subject Status='EARLY TERM' OR - Subject Metrics.Subject Status='Early Terminated' THEN - Subject Metrics.Subject Status END)

NA

Withdrawn Reason

Subject.Withdrawn Reason

Withdrawn Reason Overview (Report CDA-CO-508)

Displays (by site) the number of early terminations. This report indicates which withdrawn reasons account for the most early terminations.

Audience

- Study Manager

- Region Manager

- CRA

Report Type

- Graph, table (optional)

Location

- Study Overview dashboard, Retention Overview page

- Study-Region Overview dashboard, Retention Overview page

Dimensions

- Subject.Withdrawn Reason

- Study-Site.Study, Site, and Investigator

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

- Subjects Withdrawn List (Report CDA-CO-509)

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Withdrawn Reason Overview report.

Table A-200 Withdrawn Reason Overview (Report CDA-CO-508)

Table Heading

Column Heading

Measure/Dimension in Presentation Layer

NA

# Early Terminations

Study-site Metrics.# Early Terminations

Subject

Withdrawn Reason

Subject.Withdrawn Reason

Study-Site

Study, Site, and Investigator

Study-Site.Study, Site, and Investigator

B Oracle Health Sciences Clinical Development Analytics Presentation Catalog

The OHSCDA Presentation Catalog displays columns that you can use to create requests.

This appendix contains the following topics:

- Dimensions in OHSCDA Presentation Catalog

- Facts in OHSCDA Presentation Catalog

- Oracle Clinical Sources for OHSCDA Presentation Catalog

- Oracle's Siebel Clinical Sources for OHSCDA Presentation Catalog

- Oracle Health Sciences InForm Sources for OHSCDA Presentation Catalog

Dimensions in OHSCDA Presentation Catalog

Table B-1 describes the Dimensions displayed in the OHSCDA Presentation Catalog. For each column, it shows the name of the Column, its description, and the Dimension containing the column. The table is sorted by Dimension, and by Column within Dimension. This corresponds to how the Dimension columns are organized in the Presentation Catalog. Each Dimension column has an ID number, which is provided for cross-reference to other tables in this appendix.

Please note that some columns have been de-normalized, so that they appear in more than one Dimension. This de-normalization speeds query execution by eliminating the need for a join to that column in another Dimension. It also supports the ability to constrain columns in a Prompt, so that when you select a value in one column, the other columns are constrained to those related to your selection. When you select a de-normalized column from a Dimension, your results will be limited to the grain of the Dimension.

There are columns in the OHSCDA data warehouse that are unsourced. OHSCDA does not fetch data in these columns from any of the Oracle Clinical, Oracle's Siebel Clinical, or InForm source. These columns are provided in the OHSCDA data warehouse as a placeholder in case you do have a source to fetch data. To load the unsourced data into the OHSCDA data warehouse, you must develop the ETLs to load the data into the staging tables. The unsourced columns are mentioned within the square brackets "[]" in the presentation catalog.

Table B-1 Presentation Catalog - Dimensions

ID

Dimension

Column

Description

AD02

Time - All purpose Date

-

Time series based on Subject Status Date, Document Received Date, Site Visit Completed Date, Follow Up Item Completed Date, Discrepancy Creation Date, CRF Entry Date

AD02-07

Time - All purpose Date

Date

Calendar Date

AD02-02

Time - All purpose Date

Julian Day

Julian Day

AD02-08

Time - All purpose Date

Julian Month

Julian Month

AD02-09

Time - All purpose Date

Julian Week

Julian Week

AD02-03

Time - All purpose Date

Month

Month within calendar year

AD02-10

Time - All purpose Date

Month Name

Full name of the month

AD02-04

Time - All purpose Date

Quarter

Quarter within calendar year

AD02-06

Time - All purpose Date

Week

Week within calendar year

AD02-05

Time - All purpose Date

Year

Calendar year

AD02-11

Time - All purpose Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-13

Time - All purpose Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-12

Time - All purpose Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - 1st Site Initiated Date

-

Time series based on 1st Site Initiated Date

AD02-134

Time - 1st Site Initiated Date

Date

Calendar Date

AD02-135

Time - 1st Site Initiated Date

Julian Day

Julian Day

AD02-136

Time - 1st Site Initiated Date

Julian Month

Julian Month

AD02-137

Time - 1st Site Initiated Date

Julian Week

Julian Week

AD02-138

Time - 1st Site Initiated Date

Month

Month within calendar year

AD02-139

Time - 1st Site Initiated Date

Month Name

Full name of the month

AD02-140

Time - 1st Site Initiated Date

Quarter

Quarter within calendar year

AD02-141

Time - 1st Site Initiated Date

Week

Week within calendar year

AD02-142

Time - 1st Site Initiated Date

Year

Calendar year

AD02-143

Time - 1st Site Initiated Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-144

Time - 1st Site Initiated Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

-

Time - 1st Site Initiated Date

-

-

AD02-145

Time - 1st Site Initiated Date

Year and Week

Year and week (ex. 1994 Week10)

AD02-146

Time - 1st Subject Enrolled Date

Date

Calendar Date

AD02-147

Time - 1st Subject Enrolled Date

Julian Day

Julian Day

AD02-148

Time - 1st Subject Enrolled Date

Julian Month

Julian Month

AD02-149

Time - 1st Subject Enrolled Date

Julian Week

Julian Week

AD02-150

Time - 1st Subject Enrolled Date

Month

Month within calendar year

AD02-151

Time - 1st Subject Enrolled Date

Month Name

Full name of the month

AD02-152

Time - 1st Subject Enrolled Date

Quarter

Quarter within calendar year

AD02-153

Time - 1st Subject Enrolled Date

Week

Week within calendar year

AD02-154

Time - 1st Subject Enrolled Date

Year

Calendar year

AD02-155

Time - 1st Subject Enrolled Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-156

Time - 1st Subject Enrolled Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-157

Time - 1st Subject Enrolled Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Discrepancy Close Date

-

Time series based on Discrepancy Close Date

AD02-79

Time - Discrepancy Close Date

Date

Calendar Date

AD02-74

Time - Discrepancy Close Date

Julian Day

Julian Day

AD02-80

Time - Discrepancy Close Date

Julian Month

Julian Month

AD02-81

Time - Discrepancy Close Date

Julian Week

Julian Week

AD02-75

Time - Discrepancy Close Date

Month

Month within calendar year

AD02-82

Time - Discrepancy Close Date

Month Name

Full name of the month

AD02-76

Time - Discrepancy Close Date

Quarter

Quarter within calendar year

AD02-78

Time - Discrepancy Close Date

Week

Week within calendar year

AD02-77

Time - Discrepancy Close Date

Year

Calendar year

AD02-83

Time - Discrepancy Close Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-85

Time - Discrepancy Close Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-84

Time - Discrepancy Close Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Document Expiration Date

-

Time series based on Document Expiration Date

AD02-19

Time - Document Expiration Date

Date

Calendar Date

AD02-14

Time - Document Expiration Date

Julian Day

Julian Day

AD02-20

Time - Document Expiration Date

Julian Month

Julian Month

AD02-21

Time - Document Expiration Date

Julian Week

Julian Week

AD02-15

Time - Document Expiration Date

Month

Month within calendar year

AD02-22

Time - Document Expiration Date

Month Name

Full name of the month

AD02-16

Time - Document Expiration Date

Quarter

Quarter within calendar year

AD02-18

Time - Document Expiration Date

Week

Week within calendar year

AD02-17

Time - Document Expiration Date

Year

Calendar year

AD02-23

Time - Document Expiration Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-25

Time - Document Expiration Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-24

Time - Document Expiration Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Document Sent Date

-

Time series based on Document Sent Date

AD02-31

Time - Document Sent Date

Date

Calendar Date

AD02-26

Time - Document Sent Date

Julian Day

Julian Day

AD02-32

Time - Document Sent Date

Julian Month

Julian Month

AD02-33

Time - Document Sent Date

Julian Week

Julian Week

AD02-27

Time - Document Sent Date

Month

Month within calendar year

AD02-34

Time - Document Sent Date

Month Name

Full name of the month

AD02-28

Time - Document Sent Date

Quarter

Quarter within calendar year

AD02-30

Time - Document Sent Date

Week

Week within calendar year

AD02-29

Time - Document Sent Date

Year

Calendar year

AD02-35

Time - Document Sent Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-37

Time - Document Sent Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-36

Time - Document Sent Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Most Recent Approved Date

-

Time series based on Most Recent Approved Date

AD02-91

Time - Most Recent Approved Date

Date

Calendar Date

AD02-86

Time - Most Recent Approved Date

Julian Day

Julian Day

AD02-92

Time - Most Recent Approved Date

Julian Month

Julian Month

AD02-93

Time - Most Recent Approved Date

Julian Week

Julian Week

AD02-87

Time - Most Recent Approved Date

Month

Month within calendar year

AD02-94

Time - Most Recent Approved Date

Month Name

Full name of the month

AD02-88

Time - Most Recent Approved Date

Quarter

Quarter within calendar year

AD02-90

Time - Most Recent Approved Date

Week

Week within calendar year

AD02-89

Time - Most Recent Approved Date

Year

Calendar year

AD02-95

Time - Most Recent Approved Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-97

Time - Most Recent Approved Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-96

Time - Most Recent Approved Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Most Recent Source Verification Date

-

Time series based on Most Recent Source Verification Date

AD02-103

Time - Most Recent Source Verification Date

Date

Calendar Date

AD02-98

Time - Most Recent Source Verification Date

Julian Day

Julian Day

AD02-104

Time - Most Recent Source Verification Date

Julian Month

Julian Month

AD02-105

Time - Most Recent Source Verification Date

Julian Week

Julian Week

AD02-99

Time - Most Recent Source Verification Date

Month

Month within calendar year

AD02-106

Time - Most Recent Source Verification Date

Month Name

Full name of the month

AD02-100

Time - Most Recent Source Verification Date

Quarter

Quarter within calendar year

AD02-102

Time - Most Recent Source Verification Date

Week

Week within calendar year

AD02-101

Time - Most Recent Source Verification Date

Year

Calendar year

AD02-107

Time - Most Recent Source Verification Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-109

Time - Most Recent Source Verification Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-108

Time - Most Recent Source Verification Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Pass 1 Completion Date

-

Time series based on Pass 1 Completion Date

AD02-115

Time - Pass 1 Completion Date

Date

Calendar Date

AD02-110

Time - Pass 1 Completion Date

Julian Day

Julian Day

AD02-116

Time - Pass 1 Completion Date

Julian Month

Julian Month

AD02-117

Time - Pass 1 Completion Date

Julian Week

Julian Week

AD02-111

Time - Pass 1 Completion Date

Month

Month within calendar year

AD02-118

Time - Pass 1 Completion Date

Month Name

Full name of the month

AD02-112

Time - Pass 1 Completion Date

Quarter

Quarter within calendar year

AD02-114

Time - Pass 1 Completion Date

Week

Week within calendar year

AD02-113

Time - Pass 1 Completion Date

Year

Calendar year

AD02-119

Time - Pass 1 Completion Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-121

Time - Pass 1 Completion Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-120

Time - Pass 1 Completion Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Pass 2 Completion Date

-

Time series based on Pass 2 Completion Date

AD02-127

Time - Pass 2 Completion Date

Date

Calendar Date

AD02-122

Time - Pass 2 Completion Date

Julian Day

Julian Day

AD02-128

Time - Pass 2 Completion Date

Julian Month

Julian Month

AD02-129

Time - Pass 2 Completion Date

Julian Week

Julian Week

AD02-123

Time - Pass 2 Completion Date

Month

Month within calendar year

AD02-130

Time - Pass 2 Completion Date

Month Name

Full name of the month

AD02-124

Time - Pass 2 Completion Date

Quarter

Quarter within calendar year

AD02-126

Time - Pass 2 Completion Date

Week

Week within calendar year

AD02-125

Time - Pass 2 Completion Date

Year

Calendar year

AD02-131

Time - Pass 2 Completion Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-133

Time - Pass 2 Completion Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-132

Time - Pass 2 Completion Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Site Visit Start Date

-

Time series based on Site Visit Start Date

AD02-43

Time - Site Visit Start Date

Date

Calendar Date

AD02-38

Time - Site Visit Start Date

Julian Day

Julian Day

AD02-44

Time - Site Visit Start Date

Julian Month

Julian Month

AD02-45

Time - Site Visit Start Date

Julian Week

Julian Week

AD02-39

Time - Site Visit Start Date

Month

Month within calendar year

AD02-46

Time - Site Visit Start Date

Month Name

Full name of the month

AD02-40

Time - Site Visit Start Date

Quarter

Quarter within calendar year

AD02-42

Time - Site Visit Start Date

Week

Week within calendar year

AD02-41

Time - Site Visit Start Date

Year

Calendar year

AD02-47

Time - Site Visit Start Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-49

Time - Site Visit Start Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-48

Time - Site Visit Start Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Visit Report Approved Date

-

Time series based on Visit Report Approved Date

AD02-67

Time - Visit Report Approved Date

Date

Calendar Date

AD02-62

Time - Visit Report Approved Date

Julian Day

Julian Day

AD02-68

Time - Visit Report Approved Date

Julian Month

Julian Month

AD02-69

Time - Visit Report Approved Date

Julian Week

Julian Week

AD02-63

Time - Visit Report Approved Date

Month

Month within calendar year

AD02-70

Time - Visit Report Approved Date

Month Name

Full name of the month

AD02-64

Time - Visit Report Approved Date

Quarter

Quarter within calendar year

AD02-66

Time - Visit Report Approved Date

Week

Week within calendar year

AD02-65

Time - Visit Report Approved Date

Year

Calendar year

AD02-71

Time - Visit Report Approved Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-73

Time - Visit Report Approved Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-72

Time - Visit Report Approved Date

Year and Week

Year and week (ex. 1994 Week10)

-

Time - Visit Report Completed Date

-

Time series based on Visit Report Completed Date

AD02-55

Time - Visit Report Completed Date

Date

Calendar Date

AD02-50

Time - Visit Report Completed Date

Julian Day

Julian Day

AD02-56

Time - Visit Report Completed Date

Julian Month

Julian Month

AD02-57

Time - Visit Report Completed Date

Julian Week

Julian Week

AD02-51

Time - Visit Report Completed Date

Month

Month within calendar year

AD02-58

Time - Visit Report Completed Date

Month Name

Full name of the month

AD02-52

Time - Visit Report Completed Date

Quarter

Quarter within calendar year

AD02-54

Time - Visit Report Completed Date

Week

Week within calendar year

AD02-53

Time - Visit Report Completed Date

Year

Calendar year

AD02-59

Time - Visit Report Completed Date

Year and Month

Year and month (ex. 1994 / 02)

AD02-61

Time - Visit Report Completed Date

Year and Quarter

Year and quarter (ex. 1994 Q1)

AD02-60

Time - Visit Report Completed Date

Year and Week

Year and week (ex. 1994 Week10)

AD11

CRF

-

A Case Report Form. This is the form itself, as defined in a study, and which is assigned to be collected at various subject visits during a study.

AD11-02

CRF

CRF Name

Name of the form.

AD11-04

CRF

CRF Short Name

Short name of the form

AD11-05

CRF

DCI_ID

Oracle Clinical ID for the form.

AD11-03

CRF

Description

Free text description of the particular CRF

AD11-01

CRF

Study

Study in which the form is specified.

AD12

CRF Book

-

A specification of which CRFs are to be collected at what subject visits

AD12-01

CRF Book

CRF Book Name

Case Report Form Book (a set of forms to be collected, organized by visit): name of the book

AD12-02

CRF Book

Study

Case Report Form Book (a set of forms to be collected, organized by visit): study in which the book is to be used

AD4

Geography

-

Location of a site, in terms of a fixed hierarchy. State >- Country >- Continent.

AD04-06

Geography

City

City

AD04-01

Geography

Continent

Continent

AD04-03

Geography

Country

Country

AD04-05

Geography

County or District

County or District

AD04-07

Geography

Postal Code

Postal Code

AD04-04

Geography

State or Province

State or Province

AD5

Investigator

-

Attributes of an Investigator, who may participate in multiple studies.

AD05-19

Investigator

Investigator Action Link

Action Link for Siebel Clinical Contacts. Can be used to link back to Contact record in Siebel Clinical

AD05-11

Investigator

Investigator Business Unit

Organizational business unit

AD05-05

Investigator

Investigator City

The city where the investigator is located.

AD05-09

Investigator

Investigator Continent

Continent where the investigator is located

AD05-08

Investigator

Investigator Country

Country where the investigator is located

AD05-13

Investigator

Investigator Email Address

Investigator email address

AD05-14

Investigator

Investigator Fax/Phone #

Investigator fax/phone number

AD05-02

Investigator

Investigator First Name

Investigator's given name

AD05-03

Investigator

Investigator Full Name

Last name, then first name

AD05-01

Investigator

Investigator Last Name

Investigator's surname

AD05-15

Investigator

Investigator Middle Name

Investigator middle name

AD05-12

Investigator

Investigator Mobile #

Investigator mobile number

AD05-06

Investigator

Investigator Postal code

Postal code

AD05-07

Investigator

Investigator State

The state where the investigator is located

AD05-04

Investigator

Investigator Street Address

Investigator's street address

AD05-17

Investigator

Investigator Street Address 2

Investigator's street address - 2nd line

AD05-18

Investigator

Investigator Street Address 3

Investigator's street address - 3rd line

AD05-16

Investigator

Investigator Type

Investigator type

AD05-10

Investigator

Investigator Work Phone

Investigator's work telephone

-

Overall Level Targets

-

-

AD18-01

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

The Expected % Sites Recruiting 0 Subjects for all studies.

AD18-16

Overall Level Targets

[Program RACT Score Lower Threshold]

The lower threshold for identifying whether a Program RACT Score is High, Medium or Low.

RACT scores above or equal to this threshold are considered ”Medium” risk.

RACT scores below this threshold are considered ”Low” risk.

AD18-15

Overall Level Targets

[Program RACT Score Upper Threshold]

The upper threshold for identifying whether a Program RACT Score is High, Medium or Low.

RACT scores above or equal to this threshold are considered ”High” risk.

AD18-14

Overall Level Targets

[RACT Category Score Lower Threshold]

The lower threshold for identifying whether a RACT Category Score is High, Medium or Low.

Category scores above or equal to this threshold are considered ”Medium” risk.

Category scores below this threshold are considered ”Low” risk.

AD18-13

Overall Level Targets

[RACT Category Score Upper Threshold]

The upper threshold for identifying whether a RACT Category Score is High, Medium or Low.

Category scores above or equal to this threshold are considered ”High” risk.

AD18-18

Overall Level Targets

[Study RACT Score Lower Threshold]

The lower threshold for identifying whether a Study RACT Score is High, Medium or Low.

RACT scores above or equal to this threshold are considered ”Medium” risk.

RACT scores below this threshold are considered ”Low” risk.

AD18-17

Overall Level Targets

[Study RACT Score Upper Threshold]

The upper threshold for identifying whether a Study RACT Score is High, Medium or Low.

RACT scores above or equal to this threshold are considered ”High” risk.

AD18-20

Overall Level Targets

[Study-Region RACT Score Lower Threshold]

The lower threshold for identifying whether a Study-Region RACT Score is High, Medium or Low.

RACT scores above or equal to this threshold are considered ”Medium” risk.

RACT scores below this threshold are considered ”Low” risk.

AD18-19

Overall Level Targets

[Study-Region RACT Score Upper Threshold]

The upper threshold for identifying whether a Study-Region RACT Score is High, Medium or Low.

RACT scores above or equal to this threshold are considered ”High” risk.

AD18-22

Overall Level Targets

[Study-Site RACT Score Lower Threshold]

The lower threshold for identifying whether a Study-Site RACT Score is High, Medium or Low.

RACT scores above or equal to this threshold are considered ”Medium” risk.

RACT scores below this threshold are considered ”Low” risk.

AD18-21

Overall Level Targets

[Study-Site RACT Score Upper Threshold]

The upper threshold for identifying whether a Study-Site RACT Score is High, Medium or Low.

RACT scores above or equal to this threshold are considered ”High” risk.

AD18-10

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

The Target Critical Document Package Complete to Site Initiated (# Days) for all studies.

AD18-02

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

The Target Last Subject Last Visit to Database Lock (# Days) for all studies.

AD18-03

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

The Target Protocol Approved to 1st Site Initiated (# Days) for all studies.

AD18-04

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

The Target Protocol Approved to 1st Subject Enrolled (# Days) for all studies.

AD18-11

Overall Level Targets

[Target Protocol Approved to 1st Subject Randomized (# Days)]

The Target Protocol Approved to 1st Subject Randomized (# Days) for all studies.

AD18-12

Overall Level Targets

[Target Protocol Approved to 1st Subject Screened (# Days)]

The Target Protocol Approved to 1st Subject Screened (# Days) for all studies.

AD18-05

Overall Level Targets

[Target Site Visit Completed to Follow Up Item Completed (# Days)]

The Target Site Visit Completed to Follow Up Item Completed (# Days) for all studies.

AD18-06

Overall Level Targets

[Target Site Visit Completed to Visit Report Approved (# Days)]

The Target Site Visit Completed to Visit Report Approved (# Days) for all studies.

AD18-07

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

The Target Site Visit Completed to Visit Report Completed (# Days) for all studies.

AD18-09

Overall Level Targets

[Target Site Visit Start to Site Visit Completed (# Days)]

The Target Site Visit Start to Site Visit Completed (# Days) for all studies.

AD18-08

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

The Target Visit Report Completed to Visit Report Approved (# Days) for all studies.

AD7

Product

-

Product dimension

AD07-04

Product

Description

Product Description

AD07-09

Product

Product Action Link

Action Link for Siebel Clinical Product to link back to Product record in Siebel Clinical

AD07-01

Product

Product Name

Name of the product

AD07-07

Product

Product Number

Product #

AD07-08

Product

Product Status

Product Status

AD07-02

Product

Product Type

Type of the product

AD07-03

Product

Product Type Code

Organization's type code for the product

AD16

Program

-

Program

AD16-05

Program

[Expected % Sites Recruiting 0 Subjects]

The Expected % Sites Recruiting 0 Subjects for the Program.

AD16-02

Program

Program

Program Name

AD16-04

Program

Program Action Link

Action Link for Siebel Clinical Program. Can be used to link back to Program record in Siebel Clinical

AD16-01

Program

Program Description

Program Description

AD16-03

Program

Program Mechanism

Program Mechanism

AD16-17

Program

RACT Template Name

Name of the Template that was used for this RACT.

AD16-18

Program

RACT Completed Date

Date that the RACT was completed.

AD16-20

Program

RACT Description

Description of the RACT.

AD16-19

Program

RACT Name

Name of the RACT.

AD16-21

Program

RACT Score

Total Risk score calculated from the RACT questions.

AD16-06

Program

[Target Critical Document Package Complete to Site Initiated (# Days)]

The Target Critical Document Package Complete to Site Initiated (# Days) for the Program.

AD16-07

Program

[Target Last Subject Last Visit to Database Lock (# Days)]

The Target Last Subject Last Visit to Database Lock (# Days) for the Program.

AD16-08

Program

[Target Protocol Approved to 1st Site Initiated (# Days)]

The Target Protocol Approved to 1st Site Initiated (# Days) for the Program.

AD16-09

Program

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

The Target Protocol Approved to 1st Subject Enrolled (# Days) for the Program.

AD16-10

Program

[Target Protocol Approved to 1st Subject Randomized (# Days)]

The Target Protocol Approved to 1st Subject Randomized (# Days) for the Program.

AD16-11

Program

[Target Protocol Approved to 1st Subject Screened (# Days)]

The Target Protocol Approved to 1st Subject Screened (# Days) for the Program.

AD16-12

Program

[Target Site Visit Completed to Follow Up Item Completed (# Days)]

The Target Site Visit Completed to Follow Up Item Completed (# Days) for the Program.

AD16-13

Program

[Target Site Visit Completed to Visit Report Approved (# Days)]

The Target Site Visit Completed to Visit Report Approved (# Days) for the Program.

AD16-14

Program

[Target Site Visit Completed to Visit Report Completed (# Days)]

The Target Site Visit Completed to Visit Report Completed (# Days) for the Program.

AD16-15

Program

[Target Site Visit Start to Site Visit Completed (# Days)]

The Target Site Visit Start to Site Visit Completed (# Days) for the Program.

AD16-16

Program

[Target Visit Report Completed to Visit Report Approved (# Days)]

The Target Visit Report Completed to Visit Report Approved (# Days) for the Program.

AD23-01

RACT Category

[Functional Plan(s) Impacted]

The Functional Plan(s) that may be impacted if the RACT Category has a high risk score.

AD23-02

RACT Category

[Mitigation / Comments]

Any mitigations for the category risk or any comments about the category.

AD23-03

RACT Category

Name

The name of the RACT Category.

AD23-04

RACT Category

[Number]

The number of the RACT Category.

AD23-05

RACT Category

[Objective]

The objective of the category.

AD23-07

RACT Category

[Weight]

The weight this category is given when calculating the overall risk score.

AD17

Study-Region

-

Study Region

AD20-05

Region

[Expected % Sites Recruiting 0 Subjects]

The Expected % Sites Recruiting 0 Subjects for the Region.

AD20-06

Region

[Target Critical Document Package Complete to Site Initiated (# Days)]

The Target Critical Document Package Complete to Site Initiated (# Days) for the Region.

AD20-01

Region

[Target Site Visit Completed to Follow Up Item Completed (# Days)]

The Target Site Visit Completed to Follow Up Item Completed (# Days) for the Region.

AD20-03

Region

[Target Site Visit Completed to Visit Report Approved (# Days)]

The Target Site Visit Completed to Visit Report Approved (# Days) for the Region.

AD20-02

Region

[Target Site Visit Completed to Visit Report Completed (# Days)]

The Target Site Visit Completed to Visit Report Completed (# Days) for the Region.

AD20-08

Region

[Target Site Visit Start to Site Visit Completed (# Days)]

The Target Site Visit Start to Site Visit Completed (# Days) for the Region.

AD20-04

Region

[Target Visit Report Completed to Visit Report Approved (# Days)]

The Target Visit Report Completed to Visit Report Approved (# Days) for the Region.

AD20-07

Region

Region Name

The Region name.

AD08

Site

-

Site attributes

AD08-05

Site

Business Unit

Business Unit to which this Site belongs

AD08-12

Site

City

Site City

AD08-04

Site

Continent

Continent in which the Site is located

AD08-03

Site

Country

Country in which the Site is located

AD08-11

Site

County

Site County

AD08-10

Site

Postal Code

Site Postal Code

AD08-06

Site

Site Action Link

Action Link for Siebel Clinical Accounts. Can be used to link back to Account record in Siebel Clinical

AD08-01

Site

Site Name

Name of the Site

AD08-02

Site

State

State in which the Site is located

AD08-07

Site

Street Address

Site address line 1

AD08-08

Site

Street Address 2

Site address line 2

AD08-09

Site

Street Address 3

Site address line 3

TA-SIV

Site Visit

-

Site Visit attributes

TA-SIV11

Site Visit

Site Visit Action Link

Action Link for Siebel Clinical Site Visits. Can be used to link back to Site Visit record in Siebel Clinical

TA-SIV01

Site Visit

Site Visit Comments

Comments about the Site Visit

TA-SIV02

Site Visit

Site Visit Completed Date

Site Visit Completed Date field

TA-SIV03

Site Visit

Site Visit Name

The visit name field in the source system.

TA-SIV04

Site Visit

[Site Visit Report Approved Date]

Site Visit Report Approved Date field

TA-SIV15

Site Visit

Site Visit Report Approver

Name of the person who approved the Site Visit report.

TA-SIV05

Site Visit

Site Visit Report Completed Date

Visit Report Completed Date field

TA-SIV12

Site Visit

Site Visit Report Reviewed Date

Date the Site Visit Report was reviewed.

TA-SIV14

Site Visit

Site Visit Report Reviewer

Name of the person who reviewed the Site Visit report.

TA-SIV13

Site Visit

Site Visit Report Reviewer Comments

Comments on the Site Visit report made by the reviewer.

TA-SIV06

Site Visit

Site Visit Report Status

Visit Report Status field

TA-SIV10

Site Visit

Site Visit Report Template

The template selected to create a site visit report in the source system.

TA-SIV07

Site Visit

Site Visit Start Date

Site Visit Start Date field

TA-SIV08

Site Visit

Site Visit Status

Site Visit Status field

TA-SIV09

Site Visit

Site Visit Type

Site Visit Type field

AD9

Study

-

A description of the study

AD09-26

Study

[Clinical Study Report Date]

The Clinical Study Report Date for the Study.

AD09-07

Study

Comparative Agent

Comparative Agent

AD09-06

Study

Data Capture Mode

The mode of doing data entry in this study. Possible values are {'EDC' | 'Paper' | 'Paper and EDC' | 'Unknown'}

AD09-14

Study

Database Lock Date

Database lock date

AD09-08

Study

Diagnosis

Diagnosis

AD09-09

Study

EUDRA Number

EUDRA Number

AD09-82

Study

[Max Age Unit]

The Age Unit for the upper limit for age of subjects as defined in the protocol (Maximum Age of Subjects.

AD09-81

Study

[Maximum Age of Subjects]

The upper limit for age of subjects as defined in the protocol.

AD09-84

Study

[Min Age Unit]

The Age Unit for the lower limit for age of subjects as defined in the protocol (Minimum Age of Subjects.

AD09-83

Study

[Minimum Age of Subjects]

The lower limit for age of subjects as defined in the protocol.

AD09-35

Study

[Expected % Sites Recruiting 0 Subjects]

The Expected % Sites Recruiting 0 Subjects for the Study.

AD09-73

Study

[Expected Early Termination Rate]

The expected early termination rate for the Study.

AD09-45

Study

[Expected Retention Rate]

The Expected Retention Rate for the Study.

AD09-24

Study

[Expected Screen Failure Rate]

The Expected Screen Failure Rate for the Study.

AD09-87

Study

[Study Budget Source]

The entity (line, BU, governance, and so on) providing funds in support of the project.

AD09-88

Study

[Study Finance Code]

The finance code assigned to the study.

AD09-19

Study

[Protocol Approved Date]

The Protocol Approved Date for the Study.

AD09-69

Study

[Planned LE 1st Critical Document Package Completed Date]

The Planned LE 1st Critical Document Package Completed Date for the Study.

AD09-52

Study

[Planned LE 1st Initial IRB/EC Approval Date]

The latest estimate of the Planned 1st Initial IRB/EC Approval Date for the Study.

AD09-53

Study

[Planned LE 1st IRB/EC Submission Date]

The latest estimate of the Planned 1st IRB Submission Date for the Study.

AD09-54

Study

[Planned LE 1st Site Initiated Date]

The latest estimate of the Planned 1st Site Initiated Date for the Study.

AD09-55

Study

[Planned LE 1st Subject 1st Visit Date]

The latest estimate of the Planned 1st Subject 1st Visit Date for the Study.

AD09-56

Study

[Planned LE 1st Subject Enrolled Date]

The latest estimate of the Planned 1st Subject Enrolled Date for the Study.

AD09-57

Study

[Planned LE 1st Subject Randomized Date]

The latest estimate of the Planned 1st Subject Randomized Date for the Study.

AD09-58

Study

[Planned LE 1st Subject Screened Date]

The latest estimate of the Planned 1st Subject Screened Date for the Study.

AD09-59

Study

[Planned LE Clinical Study Report Date]

The latest estimate of the Planned Clinical Study Report Date for the Study.

AD09-60

Study

[Planned LE Database Lock Date]

The latest estimate of the Planned Database Lock Date for the Study.

AD09-61

Study

[Planned LE Last Critical Document Package Completed Date]

The latest estimate of the Planned Last Critical Document Package Completed Date for the Study.

AD09-62

Study

[Planned LE Last Site Initiated Date]

The latest estimate of the Planned Last Site Initiated Date for the Study.

AD09-63

Study

[Planned LE Last Subject 1st Visit Date]

The latest estimate of the Planned Last Subject 1st Visit Date for the Study.

AD09-64

Study

[Planned LE Last Subject Enrolled Date]

The latest estimate of the Planned Last Subject Enrolled Date for the Study.

AD09-65

Study

[Planned LE Last Subject Last Visit Date]

The latest estimate of the Planned Last Subject Last Visit Date for the Study.

AD09-66

Study

[Planned LE Last Subject Randomized Date]

The latest estimate of the Planned Last Subject Randomized Date for the Study.

AD09-67

Study

[Planned LE Protocol Approval Date]

The latest estimate of the Planned Protocol Approval Date for the Study.

AD09-48

Study

[Planned 1st Critical Document Package Completed Date]

The Planned 1st Critical Document Package Completed Date for the Study.

AD09-36

Study

[Planned 1st Initial IRB/EC Approval Date]

The Planned 1st Initial IRB/EC Approval Date for the Study.

AD09-50

Study

[Planned 1st IRB/EC Submission Date]

The Planned 1st IRB Submission Date for the Study.

AD09-49

Study

[Planned 1st Site Initiated Date]

The Planned 1st Site Initiated Date for the Study.

AD09-40

Study

[Planned 1st Subject 1st Visit Date]

The Planned 1st Subject 1st Visit Date for the Study.

AD09-46

Study

[Planned 1st Subject Enrolled Date]

The Planned 1st Subject Enrolled Date for the Study.

AD09-38

Study

[Planned 1st Subject Randomized Date]

The Planned 1st Subject Randomized Date for the Study.

AD09-39

Study

[Planned 1st Subject Screened Date]

The Planned 1st Subject Screened Date for the Study.

AD09-25

Study

[Planned Clinical Study Report Date]

The Planned Clinical Study Report Date for the Study.

AD09-20

Study

[Planned Database Lock Date]

The Planned Database Lock Date for the Study.

AD09-51

Study

[Planned Last Critical Document Package Completed Date]

The Planned Last Critical Document Package Completed Date for the Study.

AD09-41

Study

[Planned Last Site Initiated Date]

The Planned Last Site Initiated Date for the Study.

AD09-44

Study

[Planned Last Subject 1st Visit Date]

The Planned Last Subject 1st Visit Date for the Study.

AD09-42

Study

[Planned Last Subject Enrolled Date]

The Planned Last Subject Enrolled Date for the Study.

AD09-43

Study

[Planned Last Subject Last Visit Date]

The Planned Last Subject Last Visit Date for the Study.

AD09-68

Study

[Planned Last Subject Randomized Date]

The Planned Last Subject Randomized Date for the Study.

AD09-18

Study

[Planned Protocol Approval Date]

The Planned Protocol Approval Date for the Study.

AD09-17

Study

Product

The Product specified for the study

AD09-03

Study

Program

Name of the Program that owns the Study

AD09-04

Study

Project

OC Project containing the Study

AD09-77

Study

RACT Completed Date

Date that the RACT was completed.

AD09-79

Study

Description of the RACT.

AD09-78

Study

Name of the RACT.

AD09-76

Study

Name of the Template that was used for this RACT.

AD09-85

Study

The reason a protocol/center was terminated. This field is mandatory if the protocol status is set to Terminated.

AD09-01

Study

Study

Unique identifier for the Study

AD09-15

Study

Study Action Link

Action Link for Siebel Clinical Studies. Can be used to link back to Study record in Siebel Clinical

AD09-16

Study

Study Manager

The name of the primary person responsible for the study.

AD09-75

Study

Study Objective

The objective of the study.

AD09-10

Study

Study Phase

Phase

AD09-02

Study

Study Short Title

A unique short title for the Study

AD09-05

Study

Study Sponsor

Name of the Sponsor company for which this study is being conducted

AD09-11

Study

Study Status

Protocol Status

AD09-12

Study

Study Title

Title

AD09-13

Study

Study Type

Type

AD09-29

Study

[Target 1st Site Initiated to 1st Subject Enrolled (# Days)]

The Target 1st Site Initiated to 1st Subject Enrolled (# Days) for the Study.

AD09-27

Study

[Target 1st Site Initiated to Last Site Initiated (# Days)]

The Target 1st Site Initiated to Last Site Initiated (# Days) for the Study.

AD09-28

Study

[Target 1st Subject 1st Visit to Last Subject 1st Visit (# Days)]

The Target 1st Subject 1st Visit to Last Subject 1st Visit (# Days) for the Study.

AD09-47

Study

[Target 1st Subject Enrolled to Last Subject Enrolled (# Days)]

The Target 1st Subject Enrolled to Last Subject Enrolled (# Days) for the Study.

AD09-70

Study

[Target Critical Document Package Complete to Site Initiated (# Days)]

The Target Critical Document Package Complete to Site Initiated (# Days) for the Study.

M-STD14

Study

[Target Last Subject Last Visit to Database Lock (# Days)]

The Target Last Subject Last Visit to Database Lock (# Days) for the Study.

AD09-86

Study

[Target Number of Completers]

Number of subjects targeted for completion of this study.

AD09-22

Study

[Target Protocol Approved to 1st Site Initiated (# Days)]

The Target Protocol Approved to 1st Site Initiated (# Days) for the Study.

AD09-23

Study

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

The Target Protocol Approved to 1st Subject Enrolled (# Days) for the Study.

AD09-71

Study

[Target Protocol Approved to 1st Subject Randomized (# Days)]

The Target Protocol Approved to 1st Subject Randomized (# Days) for the Study.

AD09-72

Study

[Target Protocol Approved to 1st Subject Screened (# Days)]

The Target Protocol Approved to 1st Subject Screened (# Days) for the Study.

AD09-30

Study

[Target Site Visit Completed to Follow Up Item Completed (# Days)]

The Target Site Visit Completed to Follow Up Item Completed (# Days) for the Study.

AD09-31

Study

[Target Site Visit Completed to Visit Report Approved (# Days)]

The Target Site Visit Completed to Visit Report Approved (# Days) for the Study.

AD09-32

Study

[Target Site Visit Completed to Visit Report Completed (# Days)]

The Target Site Visit Completed to Visit Report Completed (# Days) for the Study.

AD09-34

Study

[Target Site Visit Start to Site Visit Completed (# Days)]

The Target Site Visit Start to Site Visit Completed (# Days) for the Study.

AD09-33

Study

[Target Visit Report Completed to Visit Report Approved (# Days)]

The Target Visit Report Completed to Visit Report Approved (# Days) for the Study.

AD09-74

Study

[Therapeutic Area]

The name of the Therapeutic Area.

-

Study Team Member

-

Study Team Member attributes

AD19-07

Study Team Member

Email

Team member email address.

AD19-06

Study Team Member

End Date

Study Team Member End Date field.

AD19-01

Study Team Member

First Name

Study Team Member First Name field.

AD19-03

Study Team Member

Full Name

Study Team Member Full Name field.

AD19-02

Study Team Member

Last Name

Study Team Member Last Name field.

AD19-04

Study Team Member

Role

Study Team Member Role field.

AD19-05

Study Team Member

Start Date

Study Team Member Start Date field.

AD19-09

Study Team Member

Team Member Active

If the team member's end date is null, indicate that the team member is active.

AD19-08

Study Team Member

Team Member Comment

Study Team Member Comment field.

-

Study-Region

-

-

AD17-04

Study-Region

Region Action Link

Action Link for Siebel Clinical Regions. Can be used to link back to Region record in Siebel Clinical

AD17-03

Study-Region

Region CRO

CRO for a Region

AD17-01

Study-Region

Region Name

Protocol Region

AD17-02

Study-Region

Region Status

Status of Region

AD17-46

Study-Region

[Clinical Study Report Date]

The Clinical Study Report Date for the Study.

AD17-47

Study-Region

[Protocol Approved Date]

The Protocol Approved Date for the Study.

AD17-22

Study-Region

[Planned LE 1st Critical Document Package Completed Date]

The latest estimate of the Planned 1st Critical Document Package Completed Date for the Study-Region.

AD17-23

Study-Region

[Planned LE 1st Initial IRB/EC Approval Date]

The latest estimate of the Planned 1st Initial IRB/EC Approval Date for the Study-Region.

AD17-24

Study-Region

[Planned LE 1st IRB/EC Submission Date]

The latest estimate of the Planned 1st IRB Submission Date for the Study-Region.

AD17-25

Study-Region

[Planned LE 1st Site Initiated Date]

The latest estimate of the Planned 1st Site Initiated Date for the Study-Region.

AD17-26

Study-Region

[Planned LE 1st Subject 1st Visit Date]

The latest estimate of the Planned 1st Subject 1st Visit Date for the Study-Region.

AD17-27

Study-Region

[Planned LE 1st Subject Enrolled Date]

The latest estimate of the Planned 1st Subject Enrolled Date for the Study-Region.

AD17-28

Study-Region

[Planned LE 1st Subject Randomized Date]

The latest estimate of the Planned 1st Subject Randomized Date for the Study-Region.

AD17-29

Study-Region

[Planned LE 1st Subject Screened Date]

The latest estimate of the Planned 1st Subject Screened Date for the Study-Region.

AD17-30

Study-Region

[Planned LE Last Critical Document Package Completed Date]

The latest estimate of the Planned Last Critical Document Package Completed Date for the Study-Region.

AD17-31

Study-Region

[Planned LE Last Site Initiated Date]

The latest estimate of the Planned Last Site Initiated Date for the Study-Region.

AD17-32

Study-Region

[Planned LE Last Subject 1st Visit Date]

The latest estimate of the Planned Last Subject 1st Visit Date for the Study-Region.

AD17-33

Study-Region

[Planned LE Last Subject Enrolled Date]

The latest estimate of the Planned Last Subject Enrolled Date for the Study-Region.

AD17-34

Study-Region

[Planned LE Last Subject Last Visit Date]

The latest estimate of the Planned Last Subject Last Visit Date for the Study-Region.

AD17-35

Study-Region

[Planned LE Last Subject Randomized Date]

The latest estimate of the Planned Last Subject Randomized Date for the Study-Region.

AD17-19

Study-Region

[Planned 1st Critical Document Package Completed Date]

The Planned 1st Critical Document Package Completed Date for the Study-Region.

AD17-09

Study-Region

[Planned 1st Initial IRB/EC Approval Date]

The Planned 1st Initial IRB/EC Approval Date for the Study-Region.

AD17-20

Study-Region

[Planned 1st IRB/EC Submission Date]

The Planned 1st IRB Submission Date for the Study-Region.

AD17-05

Study-Region

[Planned 1st Site Initiated Date]

The Planned 1st Site Initiated Date for the Study-Region.

AD17-13

Study-Region

[Planned 1st Subject 1st Visit Date]

The Planned 1st Subject 1st Visit Date for the Study-Region.

AD17-10

Study-Region

[Planned 1st Subject Enrolled Date]

The Planned 1st Subject Enrolled Date for the Study-Region.

AD17-11

Study-Region

[Planned 1st Subject Randomized Date]

The Planned 1st Subject Randomized Date for the Study-Region.

AD17-12

Study-Region

[Planned 1st Subject Screened Date]

The Planned 1st Subject Screened Date for the Study-Region.

AD17-21

Study-Region

[Planned Last Critical Document Package Completed Date]

The Planned Last Critical Document Package Completed Date for the Study-Region.

AD17-07

Study-Region

[Planned Last Site Initiated Date]

The Planned Last Site Initiated Date for the Study-Region.

AD17-15

Study-Region

[Planned Last Subject 1st Visit Date]

The Planned Last Subject 1st Visit Date for the Study-Region.

AD17-14

Study-Region

[Planned Last Subject Enrolled Date]

The Planned Last Subject Enrolled Date for the Study-Region.

AD17-16

Study-Region

[Planned Last Subject Last Visit Date]

The Planned Last Subject Last Visit Date for the Study-Region.

AD17-36

Study-Region

[Planned Last Subject Randomized Date]

The Planned Last Subject Randomized Date for the Study-Region.

AD17-06

Study-Region

[Expected % Sites Recruiting 0 Subjects]

The Expected % Sites Recruiting 0 Subjects for the Study-Region.

AD17-42

Study-Region

[Expected Early Termination Rate]

The expected early termination rate for the Study-Region.

AD17-37

Study-Region

[Expected Retention Rate]

The Expected Retention Rate for the Study-Region.

AD17-38

Study-Region

[Expected Screen Failure Rate]

The Expected Screen Failure Rate for the Study-Region.

AD17-39

Study-Region

[Target 1st Site Initiated to 1st Subject Enrolled (# Days)]

The Target 1st Site Initiated to 1st Subject Enrolled (# Days) for the Study-Region.

AD17-08

Study-Region

[Target 1st Site Initiated to Last Site Initiated (# Days)]

The Target 1st Site Initiated to Last Site Initiated (# Days) for the Study-Region.

AD17-40

Study-Region

[Target 1st Subject 1st Visit to Last Subject 1st Visit (# Days)]

The Target 1st Subject 1st Visit to Last Subject 1st Visit (# Days) for the Study-Region.

AD17-18

Study-Region

[Target 1st Subject Enrolled to Last Subject Enrolled (# Days)]

The Target 1st Subject Enrolled to Last Subject Enrolled (# Days) for the Study-Region.

AD17-41

Study-Region

[Target Critical Document Package Complete to Site Initiated (# Days)]

The Target Critical Document Package Complete to Site Initiated (# Days) for the Study-Region.

AD17-49

Study-Region

RACT Completed Date

Date that the RACT was completed.

AD17-51

Study-Region

RACT Description

Description of the RACT.

AD17-50

Study-Region

RACT Name

Name of the RACT.

AD17-48

Study-Region

RACT Template Name

Name of the Template that was used for this RACT.

AD17-43

Study-Region

Region Name

The Region name.

AD17-17

Study-Region

Study-Region Manager

The manager for the Study-Region.

AD17-44

Study-Region

Study-Region Name

The name of the Study-Region

AD17-45

Study-Region

[Therapeutic Area]

The name of the Therapeutic Area.

-

Study-Region Team Member

-

-

AD21-07

Study-Region Team Member

Email

Team member email address.

AD21-06

Study-Region Team Member

End Date

Study-Region Team Member End Date field.

AD21-01

Study-Region Team Member

First Name

Study-Region Team Member First Name field.

AD21-03

Study-Region Team Member

Full Name

Study-Region Team Member Full Name field.

AD21-02

Study-Region Team Member

Last Name

Study-Region Team Member Last Name field.

AD21-04

Study-Region Team Member

Role

Study-Region Team Member Role field.

AD21-05

Study-Region Team Member

Start Date

Study-Region Team Member Start Date field.

AD21-09

Study-Region Team Member

Team Member Active

If the team member's end date is null, indicate that the team member is active.

AD21-08

Study-Region Team Member

Team Member Comment

Study-Region Team Member Comment field.

AD8

Study-Site

-

A physical setting at which one or more studies are conducted.

AD10-10

Study-Site

1st Subject Enrolled Date

Date on which first subject was enrolled at the study-site.

AD10-32

Study-Site

City

Site City

AD10-44

Study-Site

Country

Site Country

AD10-31

Study-Site

County

Site County

AD10-42

Study-Site

CRA

The name of the primary person responsible for the study-site.

AD10-24

Study-Site

CRO

CRO conducting the study at this site

AD10-25

Study-Site

Data Capture Mode

The mode of doing data entry at this study-site. Possible values are {'EDC' | 'Paper' | 'Paper and EDC' | 'Unknown'}

TA-SITE01

Study-Site

Initial IRB/EC Approval Date

Earliest IRB Approval date for a Site

AD10-08

Study-Site

Planned Enrollment Completion Date

Date on which enrollment is (or was) planned to be complete

AD10-07

Study-Site

Planned Enrollment Start Date

Date on which enrollment is (or was) expected to start. This is the date at which subjects start being sought, not the date of the enrollment of the first subject.

AD10-33

Study-Site

Postal Code

Site Postal Code

AD10-22

Study-Site

Principal Investigator

Full name of Investigator currently responsible for the study at the site

AD10-43

Study-Site

Product

The Product specified for the study

AD10-05

Study-Site

Program

Name of the OC Program that owns the Study

AD10-06

Study-Site

Project

Name of the Project that owns the Study

AD10-51

Study-Site

[Critical Document Package Completed Date]

The Critical Document Package Completed Date for the Study-Site.

AD10-56

Study-Site

[Initial IRB/EC Submission Date]

The Initial IRB Submission Date for the Study-Site.

AD10-74

Study-Site

Site Terminated Date

The Site Terminated Date for the Study-Site.

AD10-58

Study-Site

[Planned LE 1st Subject 1st Visit Date]

The latest estimate of the Planned 1st Subject 1st Visit Date for the Study-Site.

AD10-59

Study-Site

[Planned LE 1st Subject Enrolled Date]

The latest estimate of the Planned 1st Subject Enrolled Date for the Study-Site.

AD10-60

Study-Site

[Planned LE 1st Subject Randomized Date]

The latest estimate of the Planned 1st Subject Randomized Date for the Study-Site.

AD10-61

Study-Site

[Planned LE 1st Subject Screened Date]

The latest estimate of the Planned 1st Subject Screened Date for the Study-Site.

AD10-62

Study-Site

[Planned LE Critical Document Package Completed Date]

The latest estimate of the Planned Critical Document Package Completed Date for the Study-Site.

AD10-63

Study-Site

[Planned LE Initial IRB/EC Approval Date]

The latest estimate of the Planned Initial IRB/EC Approval Date for the Study-Site.

AD10-64

Study-Site

[Planned LE IRB/EC Submission Date]

The latest estimate of the Planned IRB Submission Date for the Study-Site.

AD10-65

Study-Site

[Planned LE Last Subject 1st Visit Date]

The latest estimate of the Planned Last Subject 1st Visit Date for the Study-Site.

AD10-66

Study-Site

[Planned LE Last Subject Enrolled Date]

The latest estimate of the Planned Last Subject Enrolled Date for the Study-Site.

AD10-67

Study-Site

[Planned LE Last Subject Last Visit Date]

The latest estimate of the Planned Last Subject Last Visit Date for the Study-Site.

AD10-68

Study-Site

[Planned LE Last Subject Randomized Date]

The latest estimate of the Planned Last Subject Randomized Date for the Study-Site.

AD10-69

Study-Site

[Planned LE Site Initiated Date]

The latest estimate of the Planned Site Initiated Date for the Study-Site.

AD10-73

Study-Site

[Planned 1st Subject 1st Visit Date]

The Planned 1st Subject 1st Visit Date for the Study-Site.

AD10-47

Study-Site

[Planned 1st Subject Enrolled Date]

The Planned 1st Subject Enrolled Date for the Study-Site.

AD10-53

Study-Site

[Planned 1st Subject Randomized Date]

The Planned 1st Subject Randomized Date for the Study-Site.

AD10-52

Study-Site

[Planned 1st Subject Screened Date]

The Planned 1st Subject Screened Date for the Study-Site.

AD10-55

Study-Site

[Planned Critical Document Package Completed Date]

The Planned Critical Document Package Completed Date for the Study-Site.

AD10-50

Study-Site

[Planned Initial IRB/EC Approval Date]

The Planned Initial IRB/EC Approval Date for the Study-Site.

AD10-57

Study-Site

[Planned IRB/EC Submission Date]

The Planned IRB Submission Date for the Study-Site.

AD10-46

Study-Site

[Planned Last Subject 1st Visit Date]

The Planned Last Subject 1st Visit Date for the Study-Site.

AD10-54

Study-Site

[Planned Last Subject Enrolled Date]

The Planned Last Subject Enrolled Date for the Study-Site.

AD10-48

Study-Site

[Planned Last Subject Last Visit Date]

The Planned Last Subject Last Visit Date for the Study-Site.

AD10-70

Study-Site

[Planned Last Subject Randomized Date]

The Planned Last Subject Randomized Date for the Study-Site.

AD10-49

Study-Site

[Planned Site Initiated Date]

The Planned Site Initiated Date for the Study-Site.

AD10-72

Study-Site

[Expected Early Termination Rate]

The expected early termination rate for the Study-Site.

AD10-71

Study-Site

[Expected Retention Rate]

The expected retention rate for the Study-Site.

AD10-76

Study-Site

Latitude

The latitude of the address for the Study-Site.

AD10-77

Study-Site

Longitude

The longitude of the address for the Study-Site

AD10-78

Study-Site

Max Enrollment

The maximum number of subjects that can be enrolled at the study-site.

AD10-79

Study-Site

RACT Template Name

Name of the Template that was used for this RACT.

AD10-80

Study-Site

RACT Completed Date

Date that the RACT was completed.

AD10-81

Study-Site

RACT Name

Name of the RACT.

AD10-82

Study-Site

RACT Description

Description of the RACT.

AD10-75

Study-Site

[Therapeutic Area]

The name of the Therapeutic Area.

AD10-41

Study-Site

Site Initiated Date

Site initiation date.

AD10-01

Study-Site

Site Name

Name of the Site being used for this Study Site.

AD10-45

Study-Site

State

Site State

AD10-34

Study-Site

Street Address

Study-Site address line 1

AD10-35

Study-Site

Street Address 2

Study-Site address line 2

AD10-36

Study-Site

Street Address 3

Study-Site address line 3

AD10-04

Study-Site

Study

Unique identifier for the Study

AD10-03

Study-Site

Study Region

Name of the study-specific region in which the study site is located

AD10-38

Study-Site

Study Region Status

Status of the Study Region (denormalized from Study.Region Status)

AD10-26

Study-Site

Study Sponsor

Sponsor of the research being done at the study-site. This is meaningful only if the user is a CRO. Will be defaulted with a value of "Not Specified"

AD10-40

Study-Site

Study Status

Status of the Study (denormalized from Study.Status)

AD10-37

Study-Site

Study, Site, and Investigator

In Business Model only - concatenation of Study #, Site #, P Investigator Last Name

AD10-39

Study-Site

Study-Site Action Link

Action Link for Siebel Clinical Site. Can be used to link back to Site record in Siebel Clinical

AD10-02

Study-Site

Study-Site ID #

Unique name given the site in the context of the Study.

AD10-29

Study-Site

Study-Site Status

Site Status

AD15

Study-Site Contacts

-

Study-Site Contact attributes

AD15-01

Study-Site Contacts

City

Study-Site contact city

AD15-19

Study-Site Contacts

Contact Action Link

Action Link for Siebel Clinical Contacts. Can be used to link back to Contact record in Siebel Clinical

AD15-02

Study-Site Contacts

Country

Study-Site contact country

AD15-03

Study-Site Contacts

County

Study-Site contact county

AD15-04

Study-Site Contacts

Email Address

Study-Site contact email address

AD15-05

Study-Site Contacts

Employee Flag

Study-Site Contact Employee Flag

AD15-06

Study-Site Contacts

Fax #

Study-Site contact fax number

AD15-07

Study-Site Contacts

First Name

Contact First Name

AD15-08

Study-Site Contacts

Full Name

Last name, then first name

AD15-09

Study-Site Contacts

Last Name

Contact Last Name

AD15-10

Study-Site Contacts

Middle Name

Contact Middle Name

AD15-11

Study-Site Contacts

Mobile #

Study-Site contact mobile number

AD15-12

Study-Site Contacts

Phone #

Study-Site contact phone number

AD15-13

Study-Site Contacts

Postal Code

Study-Site contact postal code

AD15-15

Study-Site Contacts

State

Study-Site contact state

AD15-16

Study-Site Contacts

Street Address

Study-Site contact street address

AD15-17

Study-Site Contacts

Street Address 2

Study-Site Contact Address Line 2

AD15-18

Study-Site Contacts

Street Address 3

Study-Site Contact Address Line 3

AD14

Study-Site Team Member

-

Study-Site Team Member attributes

AD14-10

Study-Site Team Member

Email

Team member Email address

AD14-06

Study-Site Team Member

End Date

End Date in the Team History view

AD14-01

Study-Site Team Member

First Name

Team member first name

AD14-03

Study-Site Team Member

Full Name

Last Name, First Name

AD14-02

Study-Site Team Member

Last Name

Team member last name

AD14-04

Study-Site Team Member

Role

Role in the Team History view

AD14-05

Study-Site Team Member

Start Date

Start Date in the Team History view

AD14-08

Study-Site Team Member

Team Member Action Link

Action Link for Siebel Clinical Employee. Can be used to link back to Employee record in Siebel Clinical

AD14-09

Study-Site Team Member

Team Member Active

Indicates that the team member does not have an end date and is still actively on the team

AD14-07

Study-Site Team Member

Team Member Comment

Comment in the Team History view

TD01

Subject

-

A person taking part in a study. While a person may participate in multiple studies, each participation corresponds to a unique subject

TD01-09

Subject

Birth Date

The subject's date of birth.

TD01-03

Subject

CRF Book

The ID of the DCI book to be used for this subject.

TD01-10

Subject

Death Date

The date that the subject was reported to have died.

TD01-18

Subject

Eligible Flag

Subject Eligible Flag

TD01-06

Subject

Enrollment Date

Date and time when this subject was enrolled in this study.

TD01-20

Subject

Enrollment ID

Enrollment ID

TD01-16

Subject

Gender

The subject's gender. Values are M for male and F for female.

TD01-07

Subject

Is Active

Is the subject one about whom CRFs are to be expected? This is to differentiate between two classes of people who may be given Subject IDs: (1) people who have not yet been screened or enrolled, and thus about whom no clinical trial data is to be expected, (2) people about who clinical trial data is to be expected. Setting for this will have to be user-dependent, since it hinges on when the user assigns a subject ID, and what that signifies with respect to expectation of clinical trial data. Defaults to 'Y'.

TD01-05

Subject

Is Early Terminated

A flag to show if the subject was terminated early from the study. VARCHAR2(1)

TD01-04

Subject

Is Hard Locked

A flag to show if the system prevents any changes to the data for this subject.

TD01-25

Subject

Protocol Deviation Flag

Subject Protocol Deviation Flag

TD01-22

Subject

Protocol Violation Flag

Subject Protocol Violation Flag

TD01-29

Subject

Randomization Date

Date on which the Subject was randomized

TD01-21

Subject

Randomization ID

Randomization ID

TD01-23

Subject

Screen Failure Reason

Screen Failure Reason

TD01-24

Subject

Screening #

Screening #

TD01-17

Subject

Screening Date

Date on which subject passed screening.

TD01-01

Subject

Study

Name of the clinical study in which this subject is a participant

TD01-30

Subject

Subject Action Link

Action Link for Siebel Clinical Subjects. Can be used to link back to Subject record in Siebel Clinical

TD01-27

Subject

Subject Age

Current date minus subject Birth Date

TD01-19

Subject

Subject Comments

Subject comment

TD01-28

Subject

Subject Current Status Date

Date of subject's current status

TD01-02

Subject

Subject ID

A unique code for the subject position within the clinical study.

TD01-08

Subject

Subject Initials

The subject's initials, in mixed case.

TD01-11

Subject

Subject Status

Subject's current status

TD01-12

Subject

Subject Termination Date

Date on which the Subject ended participation in the study.

TD01-26

Subject

Withdrawn Reason

Withdrawn reason

AD22-10

Therapeutic Area

[Expected % Sites Recruiting 0 Subjects]

The Expected % Sites Recruiting 0 Subjects for the Therapeutic Area.

AD22-11

Therapeutic Area

[Target Critical Document Package Complete to Site Initiated (# Days)]

The Target Critical Document Package Complete to Site Initiated (# Days) for the Therapeutic Area.

AD22-02

Therapeutic Area

[Target Last Subject Last Visit to Database Lock (# Days)]

The Target Last Subject Last Visit to Database Lock (# Days) for the Therapeutic Area.

AD22-03

Therapeutic Area

[Target Protocol Approved to 1st Site Initiated (# Days)]

The Target Protocol Approved to 1st Site Initiated (# Days) for the Therapeutic Area.

AD22-04

Therapeutic Area

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

The Target Protocol Approved to 1st Subject Enrolled (# Days) for the Therapeutic Area.

AD22-12

Therapeutic Area

[Target Protocol Approved to 1st Subject Randomized (# Days)]

The Target Protocol Approved to 1st Subject Randomized (# Days) for the Therapeutic Area.

AD22-13

Therapeutic Area

[Target Protocol Approved to 1st Subject Screened (# Days)]

The Target Protocol Approved to 1st Subject Screened (# Days) for the Therapeutic Area.

AD22-05

Therapeutic Area

[Target Site Visit Completed to Follow Up Item Completed (# Days)]

The Target Site Visit Completed to Follow Up Item Completed (# Days) for the Therapeutic Area.

AD22-06

Therapeutic Area

[Target Site Visit Completed to Visit Report Approved (# Days)]

The Target Site Visit Completed to Visit Report Approved (# Days) for the Therapeutic Area.

AD22-07

Therapeutic Area

[Target Site Visit Completed to Visit Report Completed (# Days)]

The Target Site Visit Completed to Visit Report Completed (# Days) for the Therapeutic Area.

AD22-09

Therapeutic Area

[Target Site Visit Start to Site Visit Completed (# Days)]

The Target Site Visit Start to Site Visit Completed (# Days) for the Therapeutic Area.

AD22-08

Therapeutic Area

[Target Visit Report Completed to Visit Report Approved (# Days)]

The Target Visit Report Completed to Visit Report Approved (# Days) for the Therapeutic Area.

AD22-01

Therapeutic Area

[Therapeutic Area]

The name of the Therapeutic Area.

AD13

Validation Procedure

-

A specification of a rule that validates a particular aspect of collected data

AD13-01

Validation Procedure

Study

Study in which the Procedure is specified.

AD13-03

Validation Procedure

Validation Procedure Description

Description of the validation procedure

AD13-02

Validation Procedure

Validation Procedure Name

Name of the Validation Procedure

AD13-04

Validation Procedure

Validation Procedure Scope

Scope of data used in the Procedure:

1-EVENT 1-DCM

1-EVENT M-DCM

M-EVENT 1-DCM

M-EVENT M-DCM

THES_DERIVATION

Facts in OHSCDA Presentation Catalog

Table B-2 describes the Facts displayed in the OHSCDA Presentation Catalog, and their Columns. For each Column, it shows the name of the Column, its description, and the Fact and Group within the Fact that contain the Column. The table is sorted by Group and Column, within Fact. This corresponds to how the Fact columns are organized in the Presentation Catalog, within the Fact folder. Each Fact Column has an ID number, which is provided for cross-reference to other tables in this Appendix.

There are columns in the OHSCDA data warehouse that are unsourced. OHSCDA does not fetch data in these columns from any of the Oracle Clinical, Oracle's Siebel Clinical, or InForm source. These columns are provided in the OHSCDA data warehouse as a placeholder in case you do have any source to fetch data. To load the unsourced data into the OHSCDA data warehouse, you must develop the ETLs to load the data into the staging tables. The unsourced columns are mentioned within the square brackets "[]" in the presentation catalog.

Table B-2 Presentation Catalog - Facts

ID

Topic

Group

Column

Description

M-DSC03

Discrepancies

Counts

# Closed Discrepancies

Number of discrepancies that have either been obsolete or have been marked irresolvable.

M-DSC12

Discrepancies

Counts

# Days Current Discrepancies Open

For currently open discrepancies, number of days since creation

M-DSC11

Discrepancies

Counts

# Days Discrepancy Open

Days from creation of discrepancy to: - today, if discrepancy still open - date closed, if discrepancy closed.

M-DSC15

Discrepancies

Counts

# Days to Close Discrepancy

NULL if open; Days from creation of discrepancy to: date closed, if discrepancy closed

M-DSC09

Discrepancies

Counts

# Discrepancies Irresolvable

Number of discrepancies that have been marked irresolvable

M-DSC04

Discrepancies

Counts

# Discrepancies sent in DCFs

Number of discrepancies that have been included in one or more DCFs.

M-DSC02

Discrepancies

Counts

# Open Discrepancies

Number of discrepancies awaiting either being resolved or being marked irresolvable.

M-DSC01

Discrepancies

Counts

# Total Discrepancies

Number of discrepancies, both open and closed

TA-DISC09

Discrepancies

Transactional Data

Complete Visit Number

Planned event number || . || subevent number

TA-DISC13

Discrepancies

Transactional Data

CRF Book Page

Page within subject's CRF book where the question giving rise to the discrepancy is located

TA-DISC11

Discrepancies

Transactional Data

CRF Entry Date

Date on which the CRF containing the discrepant value was entered.

TA-DISC12

Discrepancies

Transactional Data

CRF Name

Name of the CRF (e.g. Demog) containing the discrepancy

TA-DISC14

Discrepancies

Transactional Data

CRF Page Section

Within the Page containing the discrepancy, the Section containing the discrepancy

TA-DISC15

Discrepancies

Transactional Data

CRF Question Group

Within the Page and Section, the Question Group containing the discrepancy

TA-DISC16

Discrepancies

Transactional Data

CRF Question Name

Within the Page and Section containing the discrepancy, the Question giving rise to the discrepancy

TA-DISC17

Discrepancies

Transactional Data

CRF Question Occurrence

For the Question giving rise to the discrepancy, the Occurrence Sequence Number of Question. Has value of zero if there is only one occurrence; has value in 1..n, where number of occurrences, n, is greater than zero.

TA-DISC21

Discrepancies

Transactional Data

Current Review Status

The current review status of the discrepancy. This tells where the discrepancy is in its movement through a processing workflow. The status values are initially defined by Oracle Clinical, with extensions allowed by customer.

TA-DISC26.1

Discrepancies

Transactional Data

Discrepancy Answered Date

Date when a query about the discrepancy was answered

TA-DISC26

Discrepancies

Transactional Data

Discrepancy Close Date

Date when the discrepancy was closed (i.e. closed, made obsolete, or marked irresolvable).

TA-DISC30

Discrepancies

Transactional Data

Discrepancy Comment Text

Text associated with the discrepancy

TA-DISC25

Discrepancies

Transactional Data

Discrepancy Creation Date

Date when the discrepancy was created

TA-DISC01

Discrepancies

Transactional Data

Discrepancy ID

Unique ID of the discrepancy

TA-DISC22.1

Discrepancies

Transactional Data

Discrepancy State

Open', 'Answered', 'Closed', possibly others.

TA-DISC22

Discrepancies

Transactional Data

Discrepancy Status

OC Discrepancy Status. Takes value of CURRENT, OBSOLETE

TA-DISC23

Discrepancies

Transactional Data

Discrepancy Type

How the discrepancy came into existence: Values are UNIVARIATE, MULTIVARIATE, MANUAL, and INDICATOR

TA-DISC04

Discrepancies

Transactional Data

Investigator

Study-Site Investigator

TA-DISC19

Discrepancies

Transactional Data

Is Irresolvable

True if the discrepancy review status has a long value of IRRESOLVABLE, which is OC's way of saying the review status is Irresolvable.

TA-DISC32

Discrepancies

Transactional Data

Origin

The origin of the discrepancy. Takes one of these values: {System; Non-system}

TA-DISC24

Discrepancies

Transactional Data

Resolution Type

How the discrepancy was resolved. NULL if not currently resolved. The possible values are initially defined by Oracle Clinical, with extensions allowed by customer.

TA-DISC31

Discrepancies

Transactional Data

Sent in DCF

Flag to indicate whether a discrepancy was sent in DCF

TA-DISC03

Discrepancies

Transactional Data

Site

Site at which the discrepancy was created

TA-DISC02

Discrepancies

Transactional Data

Study

Study in which the discrepancy was created

TA-DISC33

Discrepancies

Transactional Data

Study-Site

Name of the Study-Site at which the discrepancy was created

TA-DISC08

Discrepancies

Transactional Data

Sub-event Number

Sub-event number of the visit at which the value causing the discrepancy was collected

TA-DISC05

Discrepancies

Transactional Data

Subject ID

ID for the subject about whom the data were collected.

TA-DISC10

Discrepancies

Transactional Data

Subject Visit Date

Date of the subject visit when the value causing the discrepancy was collected

TA-DISC06

Discrepancies

Transactional Data

Subject Visit Name

Name of the subject visit at which the value causing the discrepancy was collected

TA-DISC07

Discrepancies

Transactional Data

Subject Visit Number

Number of the subject visit at which the value causing the discrepancy was collected

TA-DISC20

Discrepancies

Transactional Data

Validation Procedure Name

If the discrepancy arose from execution of a validation procedure, the name of that procedure. Null otherwise.

M-DRS02

Discrepancy Review Statuses

Transactional Data

# Days Discrepancy Ever in Review Status

Number of days a discrepancy ever occupied a particular discrepancy review status.

M-DRS03

Discrepancy Review Statuses

Statistics

Avg # Days Discrepancy Ever in Review Status

Number of days a discrepancy ever occupied a particular discrepancy review status, divided by the number of discrepancies ever in that review status

M-DRS04

Discrepancy Review Statuses

Statistics

Avg # Days Open Discrepancy Ever in Review Status

Number of days a currently open discrepancy ever occupied a discrepancy review status, divided by the number of discrepancies ever in that review status

M-DRS01

Discrepancy Review Statuses

Transactional Data

Discrepancy Review Status

A review status occupied by a discrepancy over the life of the discrepancy.

M-SST51

Document Metrics

Counts

# Days Document Outstanding

Number of days between Document Sent date and today's date, when Document Received date is null

M-SST50

Document Metrics

Counts

# Days from Document Sent to Document Received

Number of days between Document Sent date and Document Received Date

M-DOC02

Document Metrics

Intervals

# Days Until Document Expiration

The number of days between Document Expiration Date and today's date.

M-DOC01

Document Metrics

Counts

# Documents

Count of all Activities where Activity is Document or Site-Initiation

M-DOC03

Document Metrics

Counts

# Documents Outstanding

The number of documents with a Sent Date and no Received Date.

M-DOC04

Document Metrics

Counts

# Documents Received

The number of documents with a Received Date.

TA-DOC01

Document Metrics

Transactional Data

Activity

Document Activity

TA-DOC04

Document Metrics

Transactional Data

Activity Type

Activity Type

TA-DOC02

Document Metrics

Transactional Data

Document Comments

Document Comments

TA-DOC09

Document Metrics

Transactional Data

Document Domain

The domain of the document, such as study, region, study-site, contact, or account.

TA-DOC05

Document Metrics

Transactional Data

Document Expected Date

Document Expected Date

TA-DOC08

Document Metrics

Transactional Data

Document Expiration Date

Document Expiration Date

TA-DOC03

Document Metrics

Transactional Data

Document Name

Document Name

TA-DOC06

Document Metrics

Transactional Data

Document Received Date

Document Received Date

TA-DOC07

Document Metrics

Transactional Data

Document Sent Date

Document Sent Date

M-FUI02

Follow Up Item Metrics

Intervals

# Days Follow Up Item Open

If a Follow Up Item is resolved, the number of days between Site Visit Completed Date and Follow Up Item Completed Date. If the Follow Up Item is not resolved, the number of days between Site Visit Completed Date and today's date.

M-FUI03

Follow Up Item Metrics

Intervals

# Days Follow Up Item Outstanding

For outstanding Follow Up Items, the number of days between Parent Site Visit End and today's date.

M-FUI01

Follow Up Item Metrics

Intervals

# Days from Site Visit Completed to Follow Up Item Completed

The number of days between Site Visit Completed and Follow Up Item Resolved dates.

TA-FUI07

Follow Up Item Metrics

Transactional Data

Follow Up Item Action Link

Action Link for Siebel Clinical Follow Up Item. Can be used to link back to Follow Up Item record in Siebel Clinical

TA-FUI01

Follow Up Item Metrics

Transactional Data

Follow Up Item Comments

Follow Up Item Comments field

TA-FUI02

Follow Up Item Metrics

Transactional Data

Follow Up item Completed Date

Follow Up Item Resolved Date field

TA-FUI03

Follow Up Item Metrics

Transactional Data

Follow Up Item Created Date

Date Follow Up Item record was created

TA-FUI04

Follow Up Item Metrics

Transactional Data

Follow Up Item Description

Follow Up Item Description field

TA-FUI05

Follow Up Item Metrics

Transactional Data

Follow Up item Due Date

Follow Up Item Due Date field

TA-FUI06

Follow Up Item Metrics

Transactional Data

Follow Up Item Status

Follow Up Item Status field

TA-FUI07

Follow Up Item Metrics

Transactional Data

Follow Up Item Type

Follow Up Item Type field

M-ALL10

Overall Metrics

Counts

# Studies

The number of study records.

M-ALL09

Overall Metrics

Medians

[Median # Protocol Amendments per Study]

The median of the number of protocol amendments that occurred for all studies.

M-ALL20

Overall Metrics

Medians

[Median 1st Site Initiated to Last Site Initiated (# Days)]

The median of the following cycle time across all studies: 1st Site Initiated Date for Study to Last Site Initiated Date for Study.

M-ALL13

Overall Metrics

Medians

Median 1st Site Initiated to Latest Site Initiated (# Days)

The median of the following cycle time across all studies: 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study.

M-ALL14

Overall Metrics

Medians

[Median Critical Document Package Complete to Site Initiated (# Days)]

The median of the following cycle time across all Study-Sites: Critical Document Package Completed Date to Site Initiated Date.

M-ALL02

Overall Metrics

Medians

Median Initial IRB/EC Approval to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites: Initial IRB/EC Approval Date to 1st Subject Visit Date.

M-ALL15

Overall Metrics

Medians

Median Initial IRB/EC Approval to Site Initiated (# Days)

The median of the following cycle time across all Study-Sites: Initial IRB/EC Approval Date to Site Initiated Date.

M-ALL21

Overall Metrics

Medians

[Median Last Subject Last Visit to Database Lock (# Days)]

The median of the following cycle time across all studies: Last Subject Last Visit Date for Study to Database Lock Date.

M-ALL03

Overall Metrics

Medians

[Median Protocol Approved to 1st Site Initiated (# Days)]

The median of the following cycle time across all studies: Protocol Approved Date to 1st Site Initiated Date for Study.

M-ALL04

Overall Metrics

Medians

[Median Protocol Approved to 1st Subject Enrolled (# Days)]

The median of the following cycle time across all studies: Protocol Approved Date to 1st Subject Enrolled Date for Study.

M-ALL05

Overall Metrics

Medians

[Median Protocol Approved to 1st Subject Randomized (# Days)]

The median of the following cycle time across all studies: Protocol Approved Date to 1st Subject Randomized Date for Study.

M-ALL06

Overall Metrics

Medians

[Median Protocol Approved to 1st Subject Screened (# Days)]

The median of the following cycle time across all studies: Protocol Approved Date to 1st Subject Screened Date for Study.

M-ALL07

Overall Metrics

Medians

Median Site Initiated to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites: Site Initiated for Study-Site to 1st Subject Visit Date for Study-Site.

M-ALL16

Overall Metrics

Medians

Median Site Visit Completed to Follow Up Item Completed (# Days)

The median of the following cycle time across all completed site visits: Site Visit Completed Date to Follow Up Item Completed Date.

M-ALL17

Overall Metrics

Medians

Median Site Visit Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits: Site Visit Completed Date to Visit Report Approved Date.

M-ALL18

Overall Metrics

Medians

Median Site Visit Completed to Visit Report Completed (# Days)

The median of the following cycle time across all completed site visits: Site Visit Completed Date to Visit Report Completed Date.

M-ALL08

Overall Metrics

Medians

Median Site Visit Start to Site Visit Completed (# Days)

The median of the following cycle time across all completed site visits: Site Visit Start Date to Site Visit Completed Date.

M-ALL19

Overall Metrics

Medians

Median Visit Report Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits: Visit Report Completed Date to Visit Report Approved Date.

M-ALL01

Overall Metrics

Ratios

% Sites Recruiting 0 Subjects

The percentage of initiated sites that have not enrolled any subjects, across all studies.

M-ALL11

Overall Metrics

Ratios

% Sites Recruiting 1 or More Subjects

The percentage of Study-Sites that have at least one subject enrolled.

M-ALL12

Overall Metrics

Ratios

% Sites Recruiting at Least 90% of Planned Subjects

The percentage of Study-Sites that have enrolled 90% or more of their planned subjects.

M-PRG16

Program Metrics

Counts

# Studies

The number of study records.

M-PRG24

Program Metrics

Medians

Median # Days Between Site Visits

The median of the following cycle time across all site visits for a Program: number of days between consecutive Site Visit Start Dates for completed site visits.

M-PRG14

Program Metrics

Medians

[Median # Protocol Amendments per Study]

The median of the number of protocol amendments that occurred for all studies in a Program.

M-PRG22

Program Metrics

Medians

[Median 1st Site Initiated to Last Site Initiated (# Days)]

The median of the following cycle time across all studies in a Program: 1st Site Initiated Date for Study to Last Site Initiated Date for Study.

M-PRG01

Program Metrics

Medians

Median 1st Site Initiated to Latest Site Initiated (# Days)

The median of the following cycle time across all studies in a Program: 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study.

M-PRG19

Program Metrics

Medians

[Median Critical Document Package Complete to Site Initiated (# Days)]

The median of the following cycle time across all Study-Sites in a Program: Critical Document Package Completed Date to Site Initiated Date.

M-PRG03

Program Metrics

Medians

Median Initial IRB/EC Approval to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Program: Initial IRB/EC Approval Date to 1st Subject Visit Date.

M-PRG04

Program Metrics

Medians

Median Initial IRB/EC Approval to Site Initiated (# Days)

The median of the following cycle time across all Study-Sites in a Program: Initial IRB/EC Approval Date to Site Initiated Date.

M-PRG23

Program Metrics

Medians

[Median Last Subject Last Visit to Database Lock (# Days)]

The median of the following cycle time across all studies in a Program: Last Subject Last Visit Date for Study to Database Lock Date.

M-PRG06

Program Metrics

Medians

[Median Protocol Approved to 1st Site Initiated (# Days)]

The median of the following cycle time across all studies in a Program: Protocol Approved Date to 1st Site Initiated Date for Study.

M-PRG07

Program Metrics

Medians

[Median Protocol Approved to 1st Subject Enrolled (# Days)]

The median of the following cycle time across all studies in a Program: Protocol Approved Date to 1st Subject Enrolled Date for Study.

M-PRG21

Program Metrics

Medians

[Median Protocol Approved to 1st Subject Randomized (# Days)]

The median of the following cycle time across all studies in a Program: Protocol Approved Date to 1st Subject Randomized Date for Study.

M-PRG20

Program Metrics

Medians

[Median Protocol Approved to 1st Subject Screened (# Days)]

The median of the following cycle time across all studies in a Program: Protocol Approved Date to 1st Subject Screened Date for Study.

M-PRG08

Program Metrics

Medians

Median Site Initiated to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Program: Site Initiated for Study-Site to 1st Subject Visit Date for Study-Site.

M-PRG09

Program Metrics

Medians

Median Site Visit Completed to Follow Up Item Completed (# Days)

The median of the following cycle time across all completed site visits in a Program: Site Visit Completed Date to Follow Up Item Completed Date.

M-PRG10

Program Metrics

Medians

Median Site Visit Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits for a Program: Site Visit Completed Date to Visit Report Approved Date.

M-PRG11

Program Metrics

Medians

Median Site Visit Completed to Visit Report Completed (# Days)

The median of the following cycle time across all completed site visits for a Program: Site Visit Completed Date to Visit Report Completed Date.

M-PRG12

Program Metrics

Medians

Median Site Visit Start to Site Visit Completed (# Days)

The median of the following cycle time across all completed site visits for a Program: Site Visit Start Date to Site Visit Completed Date.

M-PRG13

Program Metrics

Medians

Median Visit Report Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits in a Program: Visit Report Completed Date to Visit Report Approved Date.

M-PRG15

Program Metrics

Ratios

% Sites Recruiting 0 Subjects

The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Program.

M-PRG17

Program Metrics

Ratios

% Sites Recruiting 1 or More Subjects

The percentage of Study-Sites that have at least one subject enrolled.

M-PRG18

Program Metrics

Ratios

% Sites Recruiting at Least 90% of Planned Subjects

The percentage of Study-Sites that have enrolled 90% or more of their planned subjects.

M-PRR12

Program RACT Metrics

-

Category Score

The risk score for the RACT Category. The score indicates the level of risk for the RACT Category.

M-PRR01

Program RACT Metrics

-

[Considerations]

Additional considerations for the question to aid in the discussion.

M-PRR02

Program RACT Metrics

-

[Detectability]

How easy is it to detect the risk? A higher detectability means a lower risk.

M-PRR03

Program RACT Metrics

-

[Functional Plan(s) Impacted]

The Functional Plan(s) that may be impacted if the RACT Question has a high risk score.

M-PRR04

Program RACT Metrics

-

Impact

What is the impact if a risk is realized? A lower impact means a lower risk.

M-PRR05

Program RACT Metrics

-

Mitigation / Comments

Any mitigations for the risk or any comments about the question.

M-PRR06

Program RACT Metrics

-

Number

The number of the question.

M-PRR07

Program RACT Metrics

-

[Probability]

The likelihood of a risk being realized. A lower probability means a lower risk.

M-PRR08

Program RACT Metrics

-

Question

Question for discussion that is being scored. Sometime called Attribute Name.

M-PRR09

Program RACT Metrics

-

[Rationale]

The rationale for the risk score.

M-PRR10

Program RACT Metrics

-

Risk Score

The risk score for this question, as calculated in the source system.

M-PRR11

Program RACT Metrics

-

Weight

The weight a score is given when calculating the total score for the Category.

M-PTL01

Protocol Version

-

Version

The version of the Protocol. This may be the original Protocol, or an amendment.

M-PTL02

Protocol Version

-

Approved Date

The date when the Protocol version was approved.

M-PTL03

Protocol Version

-

Original Version

Flag indicating if this version is the original or an amendment. Y indicates original and N indicates an amendment.

M-PTL04

Protocol Version

-

[Type]

Indicates the type of Protocol Amendment and may include such values as: Prime, Site, Region

M-PTL05

Protocol Version

-

[Amendment Avoidable]

Field used to signify if an amendment was avoidable or not

M-PTL06

Protocol Version

-

Comments

A brief description of the rationale for each change in the protocol.

M-RCF18

Received CRFs

Counts

# CRFs Awaiting Entry Completion

Count of CRFs that meet the criteria for Incomplete

M-RCF09

Received CRFs

Counts

# CRFs Blank

Count of Blank CRFs. This is the Total number of CRFs where a user has opened and marked the CRF as blank intentionally.

M-RCF19

Received CRFs

Counts

# CRFs Electronically Loaded

Number of CRFs that were electronically, i.e. batch, loaded

M-RCF01

Received CRFs

Counts

# CRFs Entry Complete

Total number of CRFs for which entry has been completed

M-RCF29.1

Received CRFs

Counts

# CRFs Hard Locked

Number of Hard Locked CRFs

M-RCF10

Received CRFs

Counts

# CRFs Present

Count of Present CRFs.

M-RCF29

Received CRFs

Counts

# CRFs Soft Locked

Number of Soft Locked CRFs

M-RCF37

Received CRFs

Intervals

# Days from CRF Entry Complete to Soft Locked

Interval between CRF Entry Complete and Soft Locked

M-RCF34

Received CRFs

Intervals

# Days from CRF Visit to Entry Complete

Interval between CRF visit date and (1) for eCRF: date on which first data entry completed; (2) for pCRF: date on which second data entry completed, if required for study, else first entry completed.

M-RCF35

Received CRFs

Intervals

# Days from eCRF Complete to Initial Verified

Interval between eCRF entry date and date of Initial Verification

M-RCF40

Received CRFs

Intervals

# Days from eCRF Complete to Soft Locked

# Days from date of eCRF Complete to Date when eCRF was Soft Locked.

M-RCF36

Received CRFs

Intervals

# Days from eCRF Entry Complete to Initially Approved

Number of days from eCRF entry completion to date when initially approved.

M-RCF38

Received CRFs

Intervals

# Days from eCRF Final Approval to Soft Locked

Number of days from most recent eCRF Approved to Soft Locked.

M-RCF30

Received CRFs

Intervals

# Days from eCRF Initially Verified to Finally Approved

For an eCRF currently both Verified and Approved, the interval, in days, between those initial verification and final approval, calculated as date(final approval) - date(initial verification)

M-RCF39

Received CRFs

Intervals

# Days from eCRF Visit to eCRF Complete

# Days from date of eCRF Visit to Date when entry complete

M-RCF76

Received CRFs

Intervals

# Days from pCRF Entry Complete to Soft Locked

Total # Days from pCRF Entry Complete to Soft Locked

M-RCF32

Received CRFs

Intervals

# Days from pCRF Pass 1 Entry to Pass 2 Entry Complete

Interval between pCRF first entry and second entry

M-RCF31.1

Received CRFs

Intervals

# Days from pCRF Visit to Entry Complete

Interval between pCRF visit date and completion of all required entry passes.

M-RCF31

Received CRFs

Intervals

# Days from pCRF Visit to Pass 1 Entry

Interval between pCRF visit date and date of first entry

M-RCF11

Received CRFs

Intervals

# Days pCRF Awaiting Pass 1 Entry

Number of days pCRF received in house, awaiting first entry, to today's date

M-RCF33

Received CRFs

Intervals

# Days pCRF Awaiting Pass 2 Entry from Pass 1 Entry

Number of days pCRF achieved first entry completion, to today's date, where pCRF status is still Pass 1 complete, and second pass is required

M-RCF24

Received CRFs

Counts

# eCRFs Approved

Number of eCRFs which have been approved by Investigator

M-RCF86

Received CRFs

Counts

# eCRFs Awaiting Entry Completion

Count of eCRFs that meet the criteria for Incomplete

M-RCF26

Received CRFs

Counts

# eCRFs Awaiting Re-Approval

Number of eCRFs requiring Re-Approval by Investigator

M-RCF22

Received CRFs

Counts

# eCRFs Awaiting Re-Verification

Number of eCRFs which require source-data Verification to be redone by the CRA/Monitor, after a change by the Investigator

M-RCF81

Received CRFs

Counts

# eCRFs Blank

Count of Blank eCRFs. This is the Total number of eCRFs where a user has opened and marked the eCRF as blank intentionally.

M-RCF68

Received CRFs

Counts

# eCRFs Entry Complete

Total number of eCRFs for which entry has been completed

M-RCF71.1

Received CRFs

Counts

# eCRFs Hard Locked

Total # of Hard Locked eCRFs

M-RCF70

Received CRFs

Counts

# eCRFs Initially Approved

Total number of eCRFs there were approved at least once

M-RCF69

Received CRFs

Counts

# eCRFs Initially Verified

Total number of eCRFs that were verified at least once

M-RCF25

Received CRFs

Counts

# eCRFs Not Approved

Number of eCRFs which require initial Approval by Investigator

M-RCF23

Received CRFs

Counts

# eCRFs Not Verified

Number of entry-complete eCRFs that have never been verified.

M-RCF75

Received CRFs

Counts

# eCRFs Present

Total # of Present # eCRFs

M-RCF72

Received CRFs

Counts

# eCRFs Soft Locked

Total number of Soft Locked eCRFs

M-RCF21.1

Received CRFs

Counts

# eCRFs To Be Approved

Number of eCRFs that either have never been approved or that are awaiting re-approval.

M-RCF21

Received CRFs

Counts

# eCRFs To be Verified

Number of eCRFs that either have never been verified or that are awaiting re-verification.

M-RCF84

Received CRFs

Counts

# eCRFs Unplanned

Number of eCRFs that are Present but collected at an unplanned event

M-RCF20

Received CRFs

Counts

# eCRFs Verified

Number of eCRFs which have been source-data verified by the CRA/Monitor

M-RCF15

Received CRFs

Counts

# pCRFs Awaiting Double Entry Reconciliation

Number of pCRFs awaiting double-entry reconciliation

M-RCF17

Received CRFs

Counts

# pCRFs Awaiting Entry Completion

Number of pCRFs awaiting completion of either first or second data entry

M-RCF08

Received CRFs

Counts

# pCRFs Awaiting Pass 1 Entry Completion

Number of pCRFs awaiting completion of first data entry, including those at Received status

M-RCF73

Received CRFs

Counts

# pCRFs Awaiting Pass 2 Entry

Total number of pCRFs Awaiting Pass 2 Entry

M-RCF16

Received CRFs

Counts

# pCRFs Awaiting Pass 2 Entry Completion

Number of pCRFs awaiting completion of second data entry

M-RCF82

Received CRFs

Counts

# pCRFs Blank

Count of Blank pCRFs. This is the Total number of pCRFs where a user has opened and marked the pCRF as blank intentionally.

M-RCF78

Received CRFs

Counts

# pCRFs Entry Complete

Total number of pCRFs for which entry has been completed

M-RCF74.1

Received CRFs

Counts

# pCRFs Hard Locked

Total # of Hard Locked pCRFs

M-RCF06

Received CRFs

Counts

# pCRFs Pass 1 Entry Started, but Incomplete

Number of pCRFs at Pass 1 Started

M-RCF07

Received CRFs

Counts

# pCRFs Pass 1 Entry Complete

Number of pCRFs at Pass 1 Complete

M-RCF14

Received CRFs

Counts

# pCRFs Pass 2 Entry Complete

Number of pCRFs completed second entry

M-RCF13

Received CRFs

Counts

# pCRFs Pass 2 Entry Started, but Incomplete

Number of pCRFs at Pass 2 Started or Pass 2 Pending

M-RCF83

Received CRFs

Counts

# pCRFs Present

Count of Present pCRFs

M-RCF05

Received CRFs

Counts

# pCRFs Received, Not Entered

Number of pCRFs at Received

M-RCF74

Received CRFs

Counts

# pCRFs Soft Locked

Total # of Soft Locked pCRFs

M-RCF85

Received CRFs

Counts

# pCRFs Unplanned

Number of pCRFs that are Present but collected at an unplanned event

M-RCF64.2

Received CRFs

Ratios

% CRFs Hard Locked / Entry Complete

100 * # CRFs Hard Locked/# CRFs Entry Complete

M-RCF62

Received CRFs

Ratios

% CRFs Soft Locked / Entry Complete

The ratio of CRFs Soft Locked to number of CRFs with Entry Complete, expressed as a percentage

M-RCF64.1

Received CRFs

Ratios

% CRFs Soft Locked / Present

% CRF Soft Locked/#CRFs Present

M-RCF55.1

Received CRFs

Ratios

% eCRFs Approved / Entry Complete

% #eCRFs Approved / # eCRFs Entry Complete

M-RCF52.1

Received CRFs

Ratios

% eCRFs Approved / Present

% # eCRFs Verified / # eCRFs Entry Complete

M-RCF64.3

Received CRFs

Ratios

% eCRFs Hard Locked / Entry Complete

100 * # eCRFs Hard Locked/# eCRFs Entry Complete

M-RCF62.1

Received CRFs

Ratios

% eCRFs Soft Locked / Entry Complete

The ratio of eCRFs Soft Locked to number of eCRFs with Entry Complete, expressed as a percentage

M-RCF58

Received CRFs

Ratios

% eCRFs Soft Locked / Present

% # eCRFs Soft Locked / # eCRFs Present

M-RCF55.2

Received CRFs

Ratios

% eCRFs Verified / Entry Complete

% #eCRFs Verified / # eCRFs Entry Complete

M-RCF52

Received CRFs

Ratios

% eCRFs Verified / Present

% # eCRFs Verified / # eCRFs Present

M-RCF64.4

Received CRFs

Ratios

% pCRFs Hard Locked / Entry Complete

100 * # pCRFs Hard Locked/# pCRFs Entry Complete

M-RCF62.2

Received CRFs

Ratios

% pCRFs Soft Locked / Entry Complete

The ratio of pCRFs Soft Locked to number of pCRFs with Entry Complete, expressed as a percentage

M-RCF65

Received CRFs

Ratios

% Processed / Present

% CRF completely entered / #CRFs Present

M-RCF64

Received CRFs

Ratios

% Re-Approval / Approved

The ratio of number of eCRFs requiring re-approval to the number currently approved expressed as a percentage.

M-RCF63

Received CRFs

Ratios

% Re-Verification / Verified

The ratio of number of eCRFs awaiting re-verification to the number currently verified, expressed as a percentage.

M-RCF49.2

Received CRFs

Statistics

Avg # Days from CRF Entry Complete to Soft Locked

For all Soft Locked CRFs, the average number of Days from date of CRF Complete to Date when CRF was Soft Locked.

M-RCF45

Received CRFs

Statistics

Avg # Days from CRF Visit to Entry Complete

Average interval between CRF visit date and (1) for eCRF: date on which first data entry completed; (2) for pCRF: date on which second data entry completed, if required for study, else first entry completed.

M-RCF46

Received CRFs

Statistics

Avg # Days from eCRF Complete to Initially Verified

Across all eCRFs that have every been set to Verified at the current level of analysis, the average number of days in the interval between eCRF entry date and date of Initial Verification

M-RCF49

Received CRFs

Statistics

Avg # Days from eCRF Complete to Soft Locked

For all Soft Locked eCRFs, the average number of Days from date of eCRF Complete to Date when eCRF was Soft Locked.

M-RCF47

Received CRFs

Statistics

Avg # Days from eCRF Entry Complete to Initially Approved

Across all eCRFs that have every been set to Approved at the current level of analysis, the average number of days in the interval between eCRF entry completion to date when initially approved.

M-RCF50

Received CRFs

Statistics

Avg # Days from eCRF Final Approval to Soft Locked

For all Soft Locked eCRFs, the average number of days from most recent eCRF Approved to Soft Locked.

M-RCF48

Received CRFs

Statistics

Avg # Days from eCRF Initially Verified to Finally Approved

For all eCRFs currently both Verified and Approved, the average interval between initial verification and final approval dates.

M-RCF41

Received CRFs

Statistics

Avg # Days from eCRF Visit to eCRF Complete

Across all eCRFs that are complete at the current level of analysis, the average number of days between the date of the visit when the CRF was collected and the date when it was Complete.

M-RCF49.1

Received CRFs

Statistics

Avg # Days from pCRF Entry Complete to Soft Locked

For all Soft Locked pCRFs, the average number of Days from date of pCRF Complete to Date when pCRF was Soft Locked.

M-RCF43

Received CRFs

Statistics

Avg # Days from pCRF First Entry to Second Entry Complete

Average interval between pCRF first entry and second entry

M-RCF45.1

Received CRFs

Statistics

Avg # Days from pCRF Visit to Entry Complete

Average interval between pCRF visit date and date on which second data entry completed, if required for study, else first entry completed.

M-RCF42

Received CRFs

Statistics

Avg # Days from pCRF Visit to First Entry

Average interval between pCRF visit date and date of first entry

M-RCF77

Received CRFs

Statistics

Avg # Days pCRF Awaiting Pass 1 Entry

Average # of Days pCRF Awaiting First Entry

M-RCF44

Received CRFs

Statistics

Avg # Days pCRF Awaiting Pass 2 Entry from Pass 1 Entry

Average number of days pCRF achieved first entry completion, to today's date, where pCRF status is still Pass 1 complete, and second pass is required

TA-RCRF09

Received CRFs

Transactional Data

Complete Visit Number

Planned event number || . || subevent number

TA-RCRF12

Received CRFs

Transactional Data

CRF Book Name

Name of the CRF Book used to organize collected pages

TA-RCRF11

Received CRFs

Transactional Data

CRF Name

Name of the CRF (e.g. Demog)

TA-RCRF35

Received CRFs

Transactional Data

Data Capture Mode

Mode in which this CRF was capture. Values = {Paper, EDC}

TA-RCRF01

Received CRFs

Transactional Data

Document ID

External identifier for the CRF

TA-RCRF14

Received CRFs

Transactional Data

Entry Date

Date on which the CRF was entered.

TA-RCRF34

Received CRFs

Transactional Data

Hard Lock Date

Date when last Hard Locked

TA-RCRF32

Received CRFs

Transactional Data

Initial Approval Date

Initial date on which the CRF was approved by the Investigator

TA-RCRF30

Received CRFs

Transactional Data

Initial Source Verification Date

Date on which the CRF was initially source-verified

TA-RCRF04

Received CRFs

Transactional Data

Investigator

Study-Site Investigator

TA-RCRF24

Received CRFs

Transactional Data

Is Awaiting First Entry completion

Flag indicating that a CRF is awaiting first entry completion

TA-RCRF20

Received CRFs

Transactional Data

Is Awaiting Re-Approval

Flag indicating whether a received CRF is awaiting re-approval

TA-RCRF17

Received CRFs

Transactional Data

Is Awaiting Re-Verification

Flag indicating whether a received CRF is awaiting re-verification

TA-RCRF25

Received CRFs

Transactional Data

Is Awaiting Second entry completion

Flag indicating that a CRF is awaiting second entry completion

TA-RCRF22

Received CRFs

Transactional Data

Is Blank

Flag indicating whether there is any data for this received DCI.

TA-RCRF26

Received CRFs

Transactional Data

Is Entry Complete

Flag indicating that a CRF is completely entered

TA-RCRF28

Received CRFs

Transactional Data

Is Hard Locked

If a Received CRF is Hard Locked, data in the cry is prevented from being modified. This can only be reversed by extraordinary means.

TA-RCRF19

Received CRFs

Transactional Data

Is not in Approved state

Flag indicating whether an eCRF has not yet ever been approved. "Y' means "not approved", else "N".

TA-RCRF16

Received CRFs

Transactional Data

Is not in Verified state

Flag indicating whether a an eCRF has not yet ever been verified. "Y' means "not verified, else "N".

TA-RCRF23

Received CRFs

Transactional Data

Is Soft Locked

If a Received CRF is Soft Locked, data in the cry is prevented from being modified. However, a soft-lock can be reversed, if it is necessary to modify data, without extraordinary measures.

TA-RCRF33

Received CRFs

Transactional Data

Most Recent Approval Date

Most recent date on which the CRF was approved by the Investigator

TA-RCRF31

Received CRFs

Transactional Data

Most Recent Source Verification Date

Most recent date on which the CRF was source-verified

TA-RCRF13

Received CRFs

Transactional Data

Page in CRF Book

Page number within subject's CRF book on which this CRF is located.

TA-RCRF15

Received CRFs

Transactional Data

Received CRF Status

Current status of the received CRF

TA-RCRF03

Received CRFs

Transactional Data

Site

Site at which the CRF was created

TA-RCRF29

Received CRFs

Transactional Data

Soft Lock Date

Date when last soft locked

TA-RCRF02

Received CRFs

Transactional Data

Study

Study in which the CRF was created

TA-RCRF08

Received CRFs

Transactional Data

Sub-event Number

Sub-event number of the visit at which the CRF was collected

TA-RCRF05

Received CRFs

Transactional Data

Subject ID

ID for the Subject about whom the data were collected.

TA-RCRF10

Received CRFs

Transactional Data

Subject Visit Date

Date of the subject visit when the CRF was collected

TA-RCRF06

Received CRFs

Transactional Data

Subject Visit Name

Name of the subject visit at which the CRF was collected

TA-RCRF07

Received CRFs

Transactional Data

Subject Visit Number

Number of the subject visit at which CRF was collected

M-REG14

Region Metrics

Counts

# Study-Regions

The number of Study-Region records.

M-REG16

Region Metrics

Medians

[Median Critical Document Package Complete to Site Initiated (# Days)]

The median of the following cycle time across all Study-Sites in a Region: Critical Document Package Completed Date to Site Initiated Date.

M-REG11

Region Metrics

Medians

Median Initial IRB/EC Approval to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Region: Initial IRB/EC Approval Date to 1st Subject Visit Date.

M-REG12

Region Metrics

Medians

Median Initial IRB/EC Approval to Site Initiated (# Days)

The median of the following cycle time across all Study-Sites in a Region: Initial IRB/EC Approval Date to Site Initiated Date.

M-REG10

Region Metrics

Medians

Median Site Initiated to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Region: Site Initiated for Study-Site to 1st Subject Visit Date for Study-Site.

M-REG15

Region Metrics

Medians

Median Site Initiated to 1st Subject Enrolled (# Days)

The median of the following cycle time across all Study-Sites in a Region: Site Initiated for Study-Site to 1st Subject Enrolled Date for Study-Site.

M-REG17

Region Metrics

Medians

Median Site Visit Completed to Follow Up Item Completed (# Days)

The median of the following cycle time across all completed site visits in a Region: Site Visit Completed Date to Follow Up Item Completed Date.

M-REG18

Region Metrics

Medians

Median Site Visit Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits for a Region: Site Visit Completed Date to Visit Report Approved Date.

M-REG19

Region Metrics

Medians

Median Site Visit Completed to Visit Report Completed (# Days)

The median of the following cycle time across all completed site visits for a Region: Site Visit Completed Date to Visit Report Completed Date.

M-REG20

Region Metrics

Medians

Median Visit Report Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits in a Region: Visit Report Completed Date to Visit Report Approved Date.

M-REG05

Region Metrics

Ratios

% Sites Recruiting 0 Subjects

The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Region.

M-REG07

Region Metrics

Ratios

% Sites Recruiting 1 or More Subjects

the number of sites recruiting one or more Subjects divided by the number of Sites Initiated.

M-REG09

Region Metrics

Ratios

% Sites Recruiting at Least 90% of Planned Subjects

the number of sites recruiting at least 90% of planned subjects divided by the number of Sites Initiated.

M-SIV01

Site Visit Metrics

Intervals

[# Days from Site Visit Completed to Visit Report Approved]

The number of days between Site Visit Completed and Visit Report Approved dates.

M-SIV02

Site Visit Metrics

Intervals

# Days from Site Visit Completed to Visit Report Completed

The number of days between Site Visit Completed and Visit Report Completed dates.

M-SIV03

Site Visit Metrics

Intervals

# Days from Site Visit Start to Site Visit Completed

Site Visit Completed Date - Site Visit Start Date

M-SIV04

Site Visit Metrics

Intervals

[# Days from Visit Report Completed to Visit Report Approved]

The number of days between Visit Report Completed and Visit Report Approved dates.

M-SIV05

Site Visit Metrics

Intervals

[# Days Visit Report Approval Outstanding]

For outstanding visit report approvals, the number of days between Site Visit report completion and today's date.

M-SIV06

Site Visit Metrics

Intervals

# Days Visit Report Completion Outstanding

For outstanding visit reports, the number of days between Site Visit End and today's date.

M-SIV07

Site Visit Metrics

Counts

# Follow Up Items

The number of Follow Up Item records.

M-SIV08

Site Visit Metrics

Counts

# Follow Up Items Completed

The number of follow up items with a Follow Up Item Completed Date.

M-SIV10

Site Visit Metrics

Counts

# Outstanding Follow Up Items

The number of unresolved Follow Up Items.

M-STD45

Study Metrics

Actual Milestones

[1st Critical Document Package Completed Date]

The earliest Critical Document Package Completed Date for all Study-Sites in the Study.

M-STD32

Study Metrics

Actual Milestones

1st Initial IRB/EC Approval Date

The first Initial IRB/EC Approval Date for all Study-Sites in the Study.

M-STD46

Study Metrics

Actual Milestones

[1st IRB/EC Submission Date]

The first IRB/EC Submission Date for all Study-Sites in the Study.

M-STD11

Study Metrics

Actual Milestones

1st Site Initiated Date

The earliest of site initiated dates for a study.

M-STD84

Study Metrics

Actual Milestones

1st Subject Visit Date

The date of the first subject visit for the Study.

M-STD85

Study Metrics

Actual Milestones

1st Subject Enrolled Date

First Subject Enrolled

M-STD86

Study Metrics

Actual Milestones

1st Subject Randomized Date

First Subject Randomized

M-STD87

Study Metrics

Actual Milestones

1st Subject Screened Date

First Subject Screened

M-STD57

Study Metrics

Actual Milestones

[Last Critical Document Package Completed Date]

The Last Critical Document Package Completed Date for the Study.

M-STD58

Study Metrics

Actual Milestones

[Last Site Initiated Date]

The Last Site Initiated Date for the Study.

M-STD59

Study Metrics

Actual Milestones

[Last Subject 1st Visit Date]

The Last Subject 1st Visit Date for the Study.

M-STD70

Study Metrics

Actual Milestones

[Last Subject Enrolled Date]

The Last Subject Enrolled Date for the Study.

M-STD68

Study Metrics

Actual Milestones

[Last Subject Visit Date]

The Last Subject Visit Date for the Study.

M-STD69

Study Metrics

Actual Milestones

[Last Subject Randomized Date]

The Last Subject Randomized Date for the Study.

M-STD47

Study Metrics

Actual Milestones

[Latest Critical Document Package Completed Date]

The Latest Critical Document Package Completed Date for the Study.

M-STD12

Study Metrics

Actual Milestones

Latest Site Initiated Date

The date of the most recent site initiated

M-STD88

Study Metrics

Actual Milestones

Latest Subject 1st Visit Date

The Latest 1st Visit Date across all subjects for the Study.

M-STD89

Study Metrics

Actual Milestones

Latest Subject Enrolled Date

Most recent date on which a subject enrolled in the study

M-STD90

Study Metrics

Actual Milestones

Latest Subject Visit Date

The Latest Subject Visit Date across all subjects for the Study.

M-STD91

Study Metrics

Actual Milestones

Latest Subject Randomized Date

Most recent date on which a subject was randomized

M-STD92

Study Metrics

Actual Milestones

Latest Subject Screened Date

Most recent date on which a subject was screened.

M-STD93

Study Metrics

Actual Milestones

[Study Design Blinding]

The type of blinding excluding washouts and run-ins.

M-STD16

Study Metrics

Counts

[# Protocol Amendments]

The number of amendments to the protocol.

M-STD114

Study Metrics

Counts

[# Protocol Amendments Avoidable]

The number of amendments to the protocol that were avoidable.

M-STD40

Study Metrics

Counts

# Sites Recruiting 0 Subjects

The number of initiated Study-Sites with 0 subjects enrolled.

M-STD42

Study Metrics

Counts

# Sites Recruiting at Least 90% of Planned Subjects

The number of initiated Study-Sites that have enrolled at least 90% of their planned subjects.

M-SST49

Study Metrics

Counts

# Sites with 1 or More Subjects Screened

Number of study-sites with 1 or more subjects screened

M-STD48

Study Metrics

Counts

# Study-Regions

The number of Study-Region records.

M-STD07

Study Metrics

Counts

# Study-Sites

# of protocol sites created for the study

M-STD13

Study Metrics

Counts

# Study-Sites Initiated

The number of initiated Study-Sites.

M-STD01

Study Metrics

Counts

# Study-Sites Planned for Study

Number of sites planned to execute the study

M-STD08

Study Metrics

Counts

# Study-Sites with 1 or more Subjects Enrolled

Number of sites with a value in the first subject enrolled date

M-STD02

Study Metrics

Counts

# Subjects Planned for Study

Total number of subjects planned to be enrolled for the Study

M-STD55

Study Metrics

Cycle Times

[1st Critical Document Package Complete to 1st Site Initiated (# Days)]

The number of days between 1st Critical Document Package Completed Date for the Study and 1st Site Initiated Date for the Study.

M-STD56

Study Metrics

Cycle Times

1st Initial IRB/EC Approval to 1st Site Initiated (# Days)

The number of days between 1st Initial IRB/EC Approval Date for the Study to 1st Site Initiated Date for the Study.

M-STD27

Study Metrics

Cycle Times

1st Initial IRB/EC Approval to 1st Subject Visit (# Days)

The number of days between 1st Initial IRB/EC Approval Date for the Study to 1st Subject Visit Date for the Study.

M-STD24

Study Metrics

Cycle Times

1st Site Initiated to 1st Subject Enrolled (# Days)

The number of days between 1st Site Initated Date for a Study and 1st Subject Enrolled Date for a Study.

M-STD65

Study Metrics

Cycle Times

[1st Site Initiated to Last Site Initiated (# Days)]

The number of days from 1st Site Initiated Date for a Study to Last Site Initiated Date for a Study.

M-STD25

Study Metrics

Cycle Times

1st Site Initiated to Latest Site Initiated (# Days)

The number of days from 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study.

M-STD66

Study Metrics

Cycle Times

[ 1st Subject Visit to Last Subject Visit (# Days)]

The number of days from 1st Subject Visit Date for a Study to Last Subject Visit Date for a Study.

M-STD26

Study Metrics

Cycle Times

1st Subject Visit to Latest Subject Visit (# Days)

The number of days from 1st Subject Visit Date for a Study to Latest Subject Visit Date for a Study.

M-STD64

Study Metrics

Cycle Times

[1st Subject Enrolled to Last Subject Enrolled (# Days)]

The number of days from 1st Subject Enrolled Date for a Study and Last Subject Enrolled Date for a Study.

M-STD61

Study Metrics

Cycle Times

1st Subject Enrolled to Latest Subject Enrolled (# Days)

The number of days from 1st Subject Enrolled Date for a Study and Latest Subject Enrolled Date for a Study.

M-STD67

Study Metrics

Cycle Times

[ Last Subject Visit to Database Lock (# Days)]

The number of days from Last Subject Visit Date for a Study to Database Lock Date for a Study.

M-STD15

Study Metrics

Cycle Times

Latest Subject Visit to Database Lock (# Days)

The number of days from Latest Subject Visit Date for a Study to Database Lock Date for a Study.

M-STD17

Study Metrics

Cycle Times

[Protocol Approved to 1st Site Initiated (# Days)]

The number of days from Protocol Approved Date for a Study to 1st Site Initiated Date for a Study.

M-STD18

Study Metrics

Cycle Times

[Protocol Approved to 1st Subject Enrolled (# Days)]

The number of days from Protocol Approved Date for a Study to 1st Subject Enrolled Date for a Study.

M-STD62

Study Metrics

Cycle Times

[Protocol Approved to 1st Subject Randomized (# Days)]

The number of days from Protocol Approved Date for a Study to 1st Subject Randomized Date for a Study.

M-STD44

Study Metrics

Cycle Times

[Protocol Approved to 1st Subject Screened (# Days)]

The number of days from Protocol Approved Date for a Study to 1st Subject Screened Date for a Study.

M-STD103

Study Metrics

Flags

[Anonymized Sample Collection]

Indicates that samples will be banked for genetic analyses after removing the subject's personal identifiers.

M-STD106

Study Metrics

Flags

[ClinTrials.Gov]

Indicates a protocol will be registered on Clinictrials.gov.

M-STD101

Study Metrics

Flags

[Compassionate Use]

Denotes a study in which the drug administered is for compassionate use only.

M-STD107

Study Metrics

Flags

[Covered Under Financial Disclosure]

Indicates this study meets the definition of "Covered" within the guidelines of Financial Disclosure.

M-STD82

Study Metrics

Flags

KPI Detail Reason

Detail reason for the Study KPI Flag

M-STD80

Study Metrics

Flags

KPI Flag

KPI Flag for the Study.

M-STD81

Study Metrics

Flags

KPI High Level Reason

High level reason for the Study KPI Flag

M-STD105

Study Metrics

Flags

[Medical Imaging]

Indicates if medical Imaging required for an endpoint to determine efficacy and/or clinical outcome.

M-STD79

Study Metrics

Flags

Milestone Detail Reason

Detail reason for the Study Milestone Flag

M-STD77

Study Metrics

Flags

Milestone Flag

Milestone Flag for the Study.

M-STD78

Study Metrics

Flags

Milestone High Level Reason

High level reason for the Study Milestone Flag

M-STD104

Study Metrics

Flags

[Non-Anonymized Genotyping]

Denotes that samples are to be used for specific genetic analyses designated in the protocol.

M-STD108

Study Metrics

Flags

[On Hold]

Indicates all forward progress on study (that is, enrollment and/or dosing) has been suspended or delayed and the study has not been terminated.

M-STD97

Study Metrics

Flags

[Pediatric Study]

Indicates whether the proposed patient population is to include under 18 years of age.

M-STD102

Study Metrics

Flags

[Pharmacogenetics Included]

Indicates that the study will involve genetic analysis.

M-STD113

Study Metrics

Flags

[Post Marketing Surveillance (PMS)]

Post Marketing Surveillance (PMS): A post marketing, non interventional study that is part of a routine national authorization process, required by regulation, and does not meet the definition of PAES or the CT34-POL definition of PASS, such as the German Anwendungs-beobachtungen [AWB] studies, Japanese, Philippine, or Korean post marketing studies.

M-STD76

Study Metrics

Flags

Recruitment Detail Reason

Detail reason for the Study Recruitment Flag.

M-STD74

Study Metrics

Flags

Recruitment Flag

Recruitment Flag for the Study.

M-STD75

Study Metrics

Flags

Recruitment High Level Reason

High level reason for the Study Recruitment Flag

M-STD73

Study Metrics

Flags

Retention Detail Reason

Detail reason for the Study Retention Flag

M-STD71

Study Metrics

Flags

Retention Flag

Retention Flag for the Study.

M-STD72

Study Metrics

Flags

Retention High Level Reason

High level reason for the Study Retention Flag

M-STD110

Study Metrics

Flags

[Study Apply DO Resources]

Indicates resources are to be applied to the study as defined by the study's governing Business Unit.

M-STD49

Study Metrics

Medians

Median # Days Between Site Visits

The median of the following cycle time across all site visits for a Study: number of days between consecutive Site Visit Start Dates for completed site visits.

M-STD50

Study Metrics

Medians

Median # Follow Up Items per Site Visit

The median of the number of follow up items per site visit for all completed site visits that occurred for a Study.

M-STD51

Study Metrics

Medians

[Median Critical Document Package Complete to Site Initiated (# Days)]

The median of the following cycle time across all Study-Sites in a Study: Critical Document Package Completed Date to Site Initiated Date.

M-STD21

Study Metrics

Medians

Median Initial IRB/EC Approval to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Study: Initial IRB/EC Approval Date to 1st Subject Visit Date.

M-STD22

Study Metrics

Medians

Median Initial IRB/EC Approval to Site Initiated (# Days)

The median of the following cycle time across all Study-Sites in a Study: Initial IRB/EC Approval Date to Site Initiated Date.

M-STD20

Study Metrics

Medians

Median Site Initiated to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Study: Site Initiated for Study-Site to 1st Subject Visit Date for Study-Site.

M-STD60

Study Metrics

Medians

Median Site Initiated to 1st Subject Enrolled (# Days)

The median of the following cycle time across all Study-Sites in a Study: Site Initiated for Study-Site to 1st Subject Enrolled Date for Study-Site.

M-STD52

Study Metrics

Medians

Median Site Visit Completed to Follow Up Item Completed (# Days)

The median of the following cycle time across all completed site visits in a Study: Site Visit Completed Date to Follow Up Item Completed Date.

M-STD53

Study Metrics

Medians

Median Site Visit Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits for a Study: Site Visit Completed Date to Visit Report Approved Date.

M-STD54

Study Metrics

Medians

Median Site Visit Completed to Visit Report Completed (# Days)

The median of the following cycle time across all completed site visits for a Study: Site Visit Completed Date to Visit Report Completed Date.

M-STD09

Study Metrics

Medians

Median Site Visit Start to Site Visit Completed (# Days)

The median of the following cycle time across all completed site visits for a Study: Site Visit Start Date to Site Visit Completed Date.

M-STD63

Study Metrics

Medians

Median Visit Report Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits in a Study: Visit Report Completed Date to Visit Report Approved Date.

M-STD43

Study Metrics

Rates

# Subject Enrollments per Month Study Active

For a Study that has not achieved database lock, the number of subject enrollments per month since the first site was Initiated. For a Study that has achieved database lock, the number of subject enrollments per month for the period between First Site Initiation and Latest Subject Enrolled at Study.

M-STD28

Study Metrics

Ratios

% of Planned Sites Initiated

The percentage of Study-Sites planned for the Study that have been initiated.

M-STD23

Study Metrics

Ratios

% Over/Under Enrolled

The percentage of planned subjects over (+) or under (-) enrolled for the Study.

M-STD06

Study Metrics

Ratios

% Planned Subject Enrollments (Study)

Ratio of number of subject enrollments to total planned number of subjects for the study.

M-STD10

Study Metrics

Ratios

% Planned Subject Randomizations (Study)

The % of planned subject randomizations.

M-STD29

Study Metrics

Ratios

% Sites Recruiting 0 Subjects

The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Study.

M-STD30

Study Metrics

Ratios

% Sites Recruiting 1 or More Subjects

the number of sites recruiting one or more Subjects divided by the number of Sites Initiated.

M-STD31

Study Metrics

Ratios

% Sites Recruiting at Least 90% of Planned Subjects

the number of sites recruiting at least 90% of planned subjects divided by the number of Sites Initiated.

M-STD83

Study Metrics

Ratios

Screen Failure Rate

The number of subjects who failed screening divided by the number of subjects screened for the Study.

M-STD94

Study Metrics

[Gender of Subjects]

Gender of subjects who may be recruited into the study

M-STD99

Study Metrics

[Planned Duration Per Subject Unit]

Maximum period of time during which a typical subject is likely to be enrolled in the study. This includes the duration of drug treatment plus any screening (signed consent form), run-in, washout and follow-up periods.

M-STD96

Study Metrics

[Sponsoring Division]

This is the division that has overall responsibility for the conduction of the study.

M-STD95

Study Metrics

[Sponsoring Unit]

The subdivision/unit that has final reporting responsibility for the study.

M-STD98

Study Metrics

[Statistical Design]

Study design that later on helps to determine what type of reporting and statistical work needs to be done with the data.

M-STD112

Study Metrics

[Study Business Group]

This is used to differentiate Clinical Research (CROps) studies from Clinical Development studies.

M-STD111

Study Metrics

[Study Design]

The study design.

M-STD109

Study Metrics

[Study Project Plan Finance Type]

The project plan type.

M-STD100

Study Metrics

[Type of Subjects Recruited]

Defines the population of study subjects.

M-SDR12

Study RACT Metrics

Category Score

The risk score for the RACT Category. The score indicates the level of risk for the RACT Category.

M-SDR13

Study RACT Metrics

-

RACT Score

Total Risk score calculated from the RACT questions.

M-SDR01

Study RACT Metrics

[Considerations]

Additional considerations for the question to aid in the discussion.

M-SDR02

Study RACT Metrics

[Detectability]

How easy is it to detect the risk? A higher detectability means a lower risk.

M-SDR03

Study RACT Metrics

[Functional Plan(s) Impacted]

The Functional Plan(s) that may be impacted if the RACT Question has a high risk score.

M-SDR04

Study RACT Metrics

Impact

What is the impact if a risk is realized? A lower impact means a lower risk.

M-SDR05

Study RACT Metrics

Mitigation / Comments

Any mitigations for the risk or any comments about the question.

M-SDR06

Study RACT Metrics

Number

The number of the question.

M-SDR07

Study RACT Metrics

[Probability]

The likelihood of a risk being realized. A lower probability means a lower risk.

M-SDR08

Study RACT Metrics

Question

Question for discussion that is being scored. Sometime called Attribute Name.

M-SDR09

Study RACT Metrics

[Rationale]

The rationale for the risk score.

M-SDR10

Study RACT Metrics

Risk Score

The risk score for this question, as calculated in the source system.

M-SDR11

Study RACT Metrics

Weight

The weight a score is given when calculating the total score for the Category.

M-STR10

Study-Region Metrics

Actual Milestones

[1st Critical Document Package Completed Date]

The earliest Critical Document Package Completed Date for all Study-Sites in the Study-Region.

M-SRG07

Study-Region Metrics

Actual Milestones

1st Initial IRB/EC Approval Date

The first Initial IRB/EC Approval Date for all Study-Sites in the Study-Region.

M-SRG33

Study-Region Metrics

Actual Milestones

[1st IRB/EC Submission Date]

The first IRB/EC Submission Date for all Study-Sites in the Study-Region.

M-SRG03

Study-Region Metrics

Actual Milestones

1st Site Initiated Date

The first Site Initiated Date for all Study-Sites in the Study-Region.

M-STR31

Study-Region Metrics

Actual Milestones

1st Subject 1st Visit Date

The date of the first visit across all subjects for the Study-Region.

M-STR32

Study-Region Metrics

Actual Milestones

1st Subject Enrolled Date

First Subject Enrolled

M-STR33

Study-Region Metrics

Actual Milestones

1st Subject Randomized Date

First Subject Randomized

M-STR34

Study-Region Metrics

Actual Milestones

1st Subject Screened Date

First Subject Screened

M-STR03

Study-Region Metrics

Actual Milestones

Date Achieved 90% Planned Enrollment

The date on which the Study-Region achieved 90% of planned subject enrollment.

M-STR04

Study-Region Metrics

Actual Milestones

[Last Critical Document Package Completed Date]

The Last Critical Document Package Completed Date for the Study-Region.

M-STR05

Study-Region Metrics

Actual Milestones

[Last Site Initiated Date]

The Last Site Initiated Date for the Study-Region.

M-STR06

Study-Region Metrics

Actual Milestones

[Last Subject 1st Visit Date]

The Last Subject 1st Visit Date for the Study-Region.

M-STR20

Study-Region Metrics

Actual Milestones

[Last Subject Enrolled Date]

The Last Subject Enrolled Date for the Study-Region.

M-STR18

Study-Region Metrics

Actual Milestones

[Last Subject Last Visit Date]

The Last Subject Last Visit Date for the Study-Region.

M-STR19

Study-Region Metrics

Actual Milestones

[Last Subject Randomized Date]

The Last Subject Randomized Date for the Study-Region.

M-SRG34

Study-Region Metrics

Actual Milestones

[Latest Critical Document Package Completed Date]

The Latest Critical Document Package Completed Date for the Study-Region.

M-SRG35

Study-Region Metrics

Actual Milestones

Latest Subject Screened Date

Most recent date on which a subject was screened.

M-SRR12

Study-Region RACT Metrics

-

Category Score

The risk score for the RACT Category. The score indicates the level of risk for the RACT Category.

M-SRR13

Study-Region RACT Metrics

-

RACT Score

Total Risk score calculated from the RACT questions.

M-SRR13

Study-Site RACT Metrics

-

RACT Score

Total Risk score calculated from the RACT questions.

M-SRR01

Study-Region RACT Metrics

-

[Considerations]

Additional considerations for the question to aid in the discussion.

M-SRR02

Study-Region RACT Metrics

-

[Detectability]

How easy is it to detect the risk? A higher detectability means a lower risk.

M-SRR03

Study-Region RACT Metrics

-

[Functional Plan(s) Impacted]

The Functional Plan(s) that may be impacted if the RACT Question has a high risk score.

M-SRR04

Study-Region RACT Metrics

-

Impact

What is the impact if a risk is realized? A lower impact means a lower risk.

M-SRR05

Study-Region RACT Metrics

-

Mitigation / Comments

Any mitigations for the risk or any comments about the question.

M-SRR06

Study-Region RACT Metrics

-

Number

The number of the question.

M-SRR07

Study-Region RACT Metrics

-

[Probability]

The likelihood of a risk being realized. A lower probability means a lower risk.

M-SRR08

Study-Region RACT Metrics

-

Question

Question for discussion that is being scored. Sometime called Attribute Name.

M-SRR09

Study-Region RACT Metrics

-

[Rationale]

The rationale for the risk score.

M-SRR10

Study-Region RACT Metrics

-

Risk Score

The risk score for this question, as calculated in the source system.

M-SRR11

Study-Region RACT Metrics

-

Weight

The weight a score is given when calculating the total score for the Category.

M-SRG05

Study-Region Metrics

Actual Milestones

Latest Site Initiated Date

The Latest Site Initiated Date for the Study-Region.

M-STR35

Study-Region Metrics

Actual Milestones

Latest Subject 1st Visit Date

The Latest 1st Visit Date across all subjects for the Study-Region.

M-STR36

Study-Region Metrics

Actual Milestones

Latest Subject Enrolled Date

Most recent date on which a subject enrolled in the study

M-STR37

Study-Region Metrics

Actual Milestones

Latest Subject Latest Visit Date

The Latest Visit Date across all subjects for the Study-Region.

M-STR38

Study-Region Metrics

Actual Milestones

Latest Subject Randomized Date

Most recent date on which a subject was randomized

M-SRG27

Study-Region Metrics

Counts

# Sites Recruiting 0 Subjects

The number of initiated Study-Sites with 0 subjects enrolled.

M-SRG28

Study-Region Metrics

Counts

# Sites Recruiting 1 or More Subjects

The number of initiated Study-Sites with one or more subjects enrolled.

M-SRG29

Study-Region Metrics

Counts

# Sites Recruiting at Least 90% of Planned Subjects

The number of Study-Sites where the number of subjects enrolled divided by the number of subjects planned for the site is greater than or equal to 90%.

M-STR30

Study-Region Metrics

Counts

# Sites with 1 or More Subjects Screened

Number of study-sites with 1 or more subjects screened

M-SRG26

Study-Region Metrics

Counts

# Study-Sites

The number of Study-Site records.

M-SRG16

Study-Region Metrics

Counts

# Study-Sites Initiated

The number of initiated Study-Sites.

M-SRG01

Study-Region Metrics

Counts

# Study-Sites Planned for Study-Region

# Planned Sites for the study-region

M-SRG02

Study-Region Metrics

Counts

# Subjects Planned for Study-Region

# Planned Subjects for the study-region

M-STR09

Study-Region Metrics

Cycle Times

[1st Critical Document Package Complete to 1st Site Initiated (# Days)]

The number of days between 1st Critical Document Package Completed Date for the Study-Region and 1st Site Initiated Date for the Study-Region.

M-SRG14

Study-Region Metrics

Cycle Times

1st Initial IRB/EC Approval to 1st Site Initiated (# Days)

The number of days between 1st Initial IRB/EC Approval Date for a Study-Region to 1st Site Initiated Date for a Study-Region.

M-SRG13

Study-Region Metrics

Cycle Times

1st Initial IRB/EC Approval to 1st Subject Visit (# Days)

The number of days between 1st Initial IRB/EC Approval Date for a Study-Region and First Subject Visit Date for a Study-Region.

M-SRG08

Study-Region Metrics

Cycle Times

1st Site Initiated to 1st Subject Enrolled (# Days)

The number of days between 1st Site Initated Date for a Study-Region and 1st Subject Enrolled Date for a Study-Region.

M-STR14

Study-Region Metrics

Cycle Times

[1st Site Initiated to Last Site Initiated (# Days)]

The number of days from 1st Site Initiated Date for a Study to Last Site Initiated Date for a Study-Region.

M-SRG06

Study-Region Metrics

Cycle Times

1st Site Initiated to Latest Site Initiated (# Days)

The number of days from 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study-Region.

M-STR15

Study-Region Metrics

Cycle Times

[1st Subject 1st Visit to Last Subject 1st Visit (# Days)]

The number of days from 1st Subject 1st Visit Date for a Study-Region to Last Subject 1st Visit Date for a Study-Region.

M-SRG12

Study-Region Metrics

Cycle Times

1st Subject Visit to Latest Subject Visit (# Days)

The number of days from 1st Subject Visit Date for a Study-Region to Latest Subject Visit Date for a Study-Region.

M-STR13

Study-Region Metrics

Cycle Times

[1st Subject Enrolled to Last Subject Enrolled (# Days)]

The number of days from 1st Subject Enrolled Date for a Study-Region to Last Subject Enrolled Date for a Study-Region.

M-STR02

Study-Region Metrics

Cycle Times

1st Subject Enrolled to Latest Subject Enrolled (# Days)

The number of days from 1st Subject Enrolled Date for a Study-Region to Latest Subject Enrolled Date for a Study-Region.

M-STR29

Study-Region Metrics

Flags

Milestone Detail Reason

Detail reason for the Study-Region Milestone Flag

M-STR27

Study-Region Metrics

Flags

Milestone Flag

Milestone Flag for the Study-Region.

M-STR28

Study-Region Metrics

Flags

Milestone High Level Reason

High level reason for the Study-Region Milestone Flag

M-STR26

Study-Region Metrics

Flags

Recruitment Detail Reason

Detail reason for the Study-Region Recruitment Flag

M-STR24

Study-Region Metrics

Flags

Recruitment Flag

Recruitment Flag for the Study-Region.

M-STR25

Study-Region Metrics

Flags

Recruitment High Level Reason

High level reason for the Study-Region Recruitment Flag

M-STR23

Study-Region Metrics

Flags

Retention Detail Reason

Detail reason for the Study-Region Retention Flag

M-STR21

Study-Region Metrics

Flags

Retention Flag

Retention Flag for the Study-Region.

M-STR22

Study-Region Metrics

Flags

Retention High Level Reason

High level reason for the Study-Region Retention Flag

M-STR11

Study-Region Metrics

Medians

Median # Days Between Site Visits

The median of the following cycle time across all site visits for a Study-Region: number of days between consecutive Site Visit Start Dates for completed site visits.

M-SRG09

Study-Region Metrics

Medians

Median # Follow Up Items per Site Visit

The median of the number of follow up items per site visit for all completed site visits that occurred for a Study-Region.

M-STR12

Study-Region Metrics

Medians

[Median Critical Document Package Complete to Site Initiated (# Days)]

The median of the following cycle time across all Study-Sites in a Study-Region: Critical Document Package Completed Date to Site Initiated Date.

M-SRG23

Study-Region Metrics

Medians

Median Initial IRB/EC Approval to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Study-Region: Initial IRB/EC Approval Date to 1st Subject Visit Date.

M-SRG24

Study-Region Metrics

Medians

Median Initial IRB/EC Approval to Site Initiated (# Days)

The median of the following cycle time across all Study-Sites in a Study-Region: Initial IRB/EC Approval Date to Site Initiated Date.

M-SRG25

Study-Region Metrics

Medians

Median Site Initiated to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Study-Region: Site Initiated for Study-Site to 1st Subject Visit Date for Study-Site.

M-STR08

Study-Region Metrics

Medians

Median Site Initiated to 1st Subject Enrolled (# Days)

The median of the following cycle time across all Study-Sites in a Study-Region: Site Initiated for Study-Site to 1st Subject Enrolled Date for Study-Site.

M-STR16

Study-Region Metrics

Medians

Median Site Visit Start to Site Visit Completed (# Days)

The median of the following cycle time across all completed site visits for a Region: Site Visit Start Date to Site Visit Completed Date.

M-SRG04

Study-Region Metrics

Ratios

% of Planned Sites Initiated

The percentage of Study-Sites planned for the Study-Region that have been initiated.

M-SRG11

Study-Region Metrics

Ratios

% Over/Under Enrolled

The percentage of planned subjects over (+) or under (-) enrolled for the Study-Region.

M-SRG10

Study-Region Metrics

Ratios

% Planned Subject Randomizations

The percentage of planned subject randomizations minus 100.

M-SRG30

Study-Region Metrics

Ratios

% Sites Recruiting 0 Subjects

The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Study-Region.

M-SRG31

Study-Region Metrics

Ratios

% Sites Recruiting 1 or More Subjects

the number of sites recruiting one or more Subjects divided by the number of Sites Initiated.

M-SRG32

Study-Region Metrics

Ratios

% Sites Recruiting at Least 90% of Planned Subjects

the number of sites recruiting at least 90% of planned subjects divided by the number of Sites Initiated.

M-STR07

Study-Region Metrics

Ratios

Screen Failure Rate

The number of subjects who failed screening divided by the number of subjects screened for the Study-Region.

M-SST96

Study-Site Metrics

Actual Milestones

1st Subject Visit Date

The date of the first subject visit for the Study-Site.

M-SST42

Study-Site Metrics

Actual Milestones

1st Subject Enrolled Date

First Subject Enrolled

M-SST43

Study-Site Metrics

Actual Milestones

1st Subject Randomized Date

First Subject Randomized

M-SST44

Study-Site Metrics

Actual Milestones

1st Subject Screened Date

First Subject Screened

M-SST88

Study-Site Metrics

Actual Milestones

Date Achieved 90% Planned Enrollment

The date on which the Study-Site achieved 90% of planned subject enrollment.

M-SST89

Study-Site Metrics

Actual Milestones

[Last Subject 1st Visit Date]

The Last Subject 1st Visit Date for the Study-Site.

M-SST90

Study-Site Metrics

Actual Milestones

[Last Subject Enrolled Date]

The Last Subject Enrolled Date for the Study-Site.

M-SST91

Study-Site Metrics

Actual Milestones

[Last Subject Visit Date]

The Last Subject Visit Date for the Study-Site.

M-SST92

Study-Site Metrics

Actual Milestones

[Last Subject Randomized Date]

The Last Subject Randomized Date for the Study-Site.

M-SST79

Study-Site Metrics

Actual Milestones

Latest Subject 1st Visit Date

The Latest 1st Visit Date across all subjects for the Study-Site.

M-SST46

Study-Site Metrics

Actual Milestones

Latest Subject Enrolled Date

Most recent date on which a subject enrolled in the study

M-SST81

Study-Site Metrics

Actual Milestones

Latest Subject Visit Date

The Latest Subject Visit Date across all subjects for the Study-Site.

M-SST47

Study-Site Metrics

Actual Milestones

Latest Subject Randomized Date

Most recent date on which a subject was randomized

M-SST48

Study-Site Metrics

Actual Milestones

Latest Subject Screened Date

Most recent date on which a subject was screened

M-SST61

Study-Site Metrics

Counts

# Completed Site Visits

The number of Site Visit records with a Site Visit Completed Date

M-SST62

Study-Site Metrics

Counts

# Completed Visit Reports

The number of Visit Reports where Completed Date is not null.

M-SST04

Study-Site Metrics

Counts

# Current Active Subjects

Total number of Subjects currently conducting Study

M-SST03

Study-Site Metrics

Counts

# Currently Enrolled plus # Normally Terminated

The total number of subjects who are either currently enrolled or who have normally completed the study protocol

M-SST39

Study-Site Metrics

Counts

# Days Since Initiation

Number of days from current date to Site Initiation Date

M-SST06

Study-Site Metrics

Counts

# Early Terminations

# Subjects who have ever had a status of Early Terminated

M-SST02

Study-Site Metrics

Counts

# Enrolled

# Subjects who have ever had a status of Enrolled

For the value of # Enrolled measure to get populated from OC correctly, you must create a validation procedure to populate the Patient Statuses table for each study using two packaged procedures provided with Oracle Clinical. For information on how to create a validation procedure, see Oracle Clinical Creating a Study.

M-SST08

Study-Site Metrics

Counts

# Planned Subject Visits Completed

Number of planned Subject visits which have occurred. This is the count, across all CRFs received for all subjects at the site, of distinct planned visits at which the CRFs were collected. Planned visits are those for which sub-event number is zero.

M-SST32

Study-Site Metrics

Counts

# Randomized

# Subjects who have ever had a status of Randomized

M-SST33

Study-Site Metrics

Counts

# Re-Screened

# Subjects who have ever had a status of Re-screened

M-SST34

Study-Site Metrics

Counts

# Screen Failure

# Subjects who have ever had a status of Screen Failure

M-SST35

Study-Site Metrics

Counts

# Screened

# Subjects who have ever had a status of Screened

M-SST65

Study-Site Metrics

Counts

# Site Visits

The number of Site Visit records

M-SST36

Study-Site Metrics

Counts

# Subjects

Count of the number of subject records returned

M-SST05C

Study-Site Metrics

Counts

# Subjects - Current Status Completed

# Subjects with a current status of Completed

M-SST06C

Study-Site Metrics

Counts

# Subjects - Current Status Early Terminated

Number of Subjects whose current status is Early Terminated

M-SST02C

Study-Site Metrics

Counts

# Subjects - Current Status Enrolled

# Subjects with a current status of Enrolled

M-SST32C

Study-Site Metrics

Counts

# Subjects - Current Status Randomized

# Subjects with a current status of Randomized

M-SST33C

Study-Site Metrics

Counts

# Subjects - Current Status Re-Screened

# Subjects with a current status of Re-screened

M-SST34C

Study-Site Metrics

Counts

# Subjects - Current Status Screen Failure

# Subjects with a current status of Screen failure

M-SST35C

Study-Site Metrics

Counts

# Subjects - Current Status Screened

# Subjects with a current status of Screened

M-SST37

Study-Site Metrics

Counts

# Subjects Deviation

Number of subjects with the Protocol Deviation flag checked

M-SST66

Study-Site Metrics

Counts

# Subject Enrollments Since Latest Site Visit

Number of subject enrollments since most recent site visit end date.

M-SST01

Study-Site Metrics

Counts

# Subjects Planned for Study-Site

Total number of subjects planned to be enrolled at the Study-Site.

M-SST67

Study-Site Metrics

Counts

# Subject Randomizations Since Latest Site Visit

Number of subject randomizations since most recent site visit end date.

M-SST68

Study-Site Metrics

Counts

# Subject Screenings Since Latest Site Visit

Number of subject randomizations since most recent site visit end date.

M-SST38

Study-Site Metrics

Counts

# Subjects Violation

Number of subjects with the Protocol Violation flag checked

M-SST05

Study-Site Metrics

Counts

# Subjects who have Completed Study

# Subjects who have ever had a status of Completed

M-SST09

Study-Site Metrics

Counts

# Unplanned Subject Visits Completed

Number of unplanned Subject visits which have occurred. This is the count, across all CRFs received for all subjects at the site, of distinct unplanned visits at which the CRFs were collected. Unplanned visits are those for which sub-event number is greater than zero.

M-SST69

Study-Site Metrics

Counts

# Visit Reports

The number of visit report records

M-SST70

Study-Site Metrics

Counts

[# Visit Reports Awaiting Approval]

The number of visit reports where Completed Date is not null and Approved Date is null

M-SST71

Study-Site Metrics

Counts

# Visit Reports Awaiting Completion

The number of visit reports with a site visit end date but no visit report completion date

M-SST95

Study-Site Metrics

Cycle Times

[ 1st Subject Visit to Last Subject Visit (# Days)]

The number of days from 1st Subject Visit Date for a Study-Site to Last Subject Visit Date for a Study-Site.

M-SST80

Study-Site Metrics

Cycle Times

1st Subject Visit to Latest Subject Visit (# Days)

The number of days from 1st Subject Visit Date for a Study-Site to Latest Subject Visit Date for a Study-Site.

M-SST85

Study-Site Metrics

Cycle Times

[Critical Document Package Complete to Site Initiated (# Days)]

The number of days from Critical Document Package Completed for a Study-Site to Site Initiated Date.

M-SST83

Study-Site Metrics

Cycle Times

Initial IRB/EC Approval to 1st Subject Visit (# Days)

The number of days from Initial IRB/EC Approval Date for a Study-Site and 1st Subject Visit for a Study-Site.

M-SST84

Study-Site Metrics

Cycle Times

Initial IRB/EC Approval to Site Initiated (# Days)

The number of days from Initial IRB/EC Approval Date for a Study-Site and Site Initiated Date for a Study-Site.

M-SST82

Study-Site Metrics

Cycle Times

Site Initiated to 1st Subject Visit (# Days)

The number of days from Site Initiated Date for a Study-Site to 1st Subject Visit Date for a Study-Site.

M-SST93

Study-Site Metrics

Cycle Times

Site Initiated to 1st Subject Enrolled (# Days)

The number of days from Site Initiated Date for a Study-Site to 1st Subject Enrolled Date for a Study-Site.

M-SST105

Study-Site Metrics

Flags

Milestone Detail Reason

Detail reason for the Study-Site Milestone Flag

M-SST106

Study-Site Metrics

Counts

[# Times Study-Site Missed Dose]

The number of times a Study-Site missed a dose at Site due to lack of drug supply.

M-SST103

Study-Site Metrics

Flags

Milestone Flag

Milestone Flag for the Study-Site.

M-SST104

Study-Site Metrics

Flags

Milestone High Level Reason

High level reason for the Study-Site Milestone Flag

M-SST102

Study-Site Metrics

Flags

Recruitment Detail Reason

Detail reason for the Study-Site Recruitment Flag

M-SST100

Study-Site Metrics

Flags

Recruitment Flag

Recruitment Flag for the Study-Region.

M-SST101

Study-Site Metrics

Flags

Recruitment High Level Reason

High level reason for the Study-Site Recruitment Flag

M-SST99

Study-Site Metrics

Flags

Retention Detail Reason

Detail reason for the Study-Site Retention Flag

M-SMD01

Study-Site Missed Dose

-

[Date Dose Missed]

Date of Missed dose at Site due to lack of drug supply

M-SMD02

Study-Site Missed Dose

-

[Entry Date]

Date missed dose was entered into the system

M-SMD03

Study-Site Missed Dose

-

[Reason]

Reason for missed dosing

M-SSR12

Study-Site RACT Metrics

-

Category Score

The risk score for the RACT Category. The score indicates the level of risk for the RACT Category.

M-SSR01

Study-Site RACT Metrics

-

[Considerations]

Additional considerations for the question to aid in the discussion.

M-SSR02

Study-Site RACT Metrics

-

[Detectability]

How easy is it to detect the risk? A higher detectability means a lower risk.

M-SSR03

Study-Site RACT Metrics

-

[Functional Plan(s) Impacted]

The Functional Plan(s) that may be impacted if the RACT Question has a high risk score.

M-SSR04

Study-Site RACT Metrics

-

Impact

What is the impact if a risk is realized? A lower impact means a lower risk.

M-SSR05

Study-Site RACT Metrics

-

Mitigation / Comments

Any mitigations for the risk or any comments about the question.

M-SSR06

Study-Site RACT Metrics

-

Number

The number of the question.

M-SSR07

Study-Site RACT Metrics

-

[Probability]

The likelihood of a risk being realized. A lower probability means a lower risk.

M-SSR08

Study-Site RACT Metrics

-

Question

Question for discussion that is being scored. Sometime called Attribute Name.

M-SSR09

Study-Site RACT Metrics

-

[Rationale]

The rationale for the risk score.

M-SSR10

Study-Site RACT Metrics

-

Risk Score

The risk score for this question, as calculated in the source system.

M-SSR11

Study-Site RACT Metrics

-

Weight

The weight a score is given when calculating the total score for the Category.

M-SST97

Study-Site Metrics

Flags

Retention Flag

Retention Flag for the Study-Site.

M-SST98

Study-Site Metrics

Flags

Retention High Level Reason

High level reason for the Study-Site Retention Flag

M-SST52

Study-Site Metrics

Intervals

# Days Since Last Enrollment for Study-Site

Number of days between today's date and the most recent enrollment date at the study-site

M-SST63

Study-Site Metrics

Intervals

# Days Since Latest Site Visit

The number of dates since the most recent completed site visit.

M-SST76

Study-Site Metrics

Medians

Median # Days Between Site Visits

The median of the following cycle time across all site visits for a Study-Site: number of days between consecutive Site Visit Start Dates for completed site visits.

M-SST77

Study-Site Metrics

Medians

Median # Follow Up Items per Site Visit

The median of the number of follow up items per site visit for all completed site visits that occurred for a Study-Site.

M-SST86

Study-Site Metrics

Rates

# Subjects Enrolled per Site per Month Site Active

For a Study-Site that does not have a terminated date, the number of subjects enrolled since the Study-Site was initiated. For a Study-Site that has a terminated date, the number of subjects enrolled per month for the period between Study-Site initiation and latest subject enrolled at Study-Site

M-SST15.1

Study-Site Metrics

Ratios

% Enrolled to Total Planned at Study-Site

Ratio of number of enrolled subjects to total planned number of subjects for the study site.

M-SST54

Study-Site Metrics

Ratios

% of Total Enrolled in Study

The number of subjects enrolled at study-site divided by the number of subjects enrolled in the study

M-SST55

Study-Site Metrics

Ratios

% of Total Randomized in Study

The number of subjects randomized at study-site divided by the number of subjects randomized in study

M-SST56

Study-Site Metrics

Ratios

% of Total Screened in Study

The number of subjects screened at study-site divided by the number of subjects screened in study

M-SST94

Study-Site Metrics

Ratios

% Over/Under Enrolled

The percentage of planned subjects over (+) or under (-) enrolled for the Study-Site.

M-SST72

Study-Site Metrics

Ratios

% Randomized vs. Planned for Study-Site

The % of planned subjects randomized.

M-SST58

Study-Site Metrics

Ratios

% Subjects Early Terminated for Study

The number of subjects early terminated in study divided by the number of subjects enrolled in study

M-SST57

Study-Site Metrics

Ratios

% Subjects Early Terminated for Study-Site

The number of subjects early terminated at study-site divided by the number of subjects enrolled at study-site

M-SST19

Study-Site Metrics

Ratios

Closed Discrepancies per CRF

Number of Closed Discrepancies per CRF currently Present

M-SST23

Study-Site Metrics

Ratios

Closed Discrepancies per Enrolled Subject

Number of closed discrepancies per currently enrolled Subject

M-SST17

Study-Site Metrics

Ratios

Open Discrepancies per CRF

Number of Open Discrepancies per CRF currently Present

M-SST20

Study-Site Metrics

Ratios

Open Discrepancies per Enrolled Subject

Number of Open Discrepancies per currently enrolled Subject

M-SST87

Study-Site Metrics

Ratios

Screen Failure Rate

The number of subjects who failed screening divided by the number of subjects screened for the Study-Site.

M-SST18

Study-Site Metrics

Ratios

Total Discrepancies per CRF

Number of all Discrepancies (Open or Closed) per CRF currently Present

M-SST21

Study-Site Metrics

Ratios

Total Discrepancies per Enrolled Subject

Number of all Discrepancies (Open or Closed) per currently enrolled Subject

M-SST73

Study-Site Metrics

Statistics

1st Site Visit Date since Site Initiated

The Site Visit Start Date of the first site visit that occurred after the Site Initiated Date.

M-SST41

Study-Site Metrics

Statistics

1st Subject Completed Date

Earliest date on which a subject completed the study

M-SST40

Study-Site Metrics

Statistics

1st Subject Withdrawn Date

Earliest date on which a subject withdrew (Status is Early Terminated) from the study

M-SST59

Study-Site Metrics

Statistics

Avg # Days Document Outstanding

Average number of days between Document Sent date and today's date,

M-SST60

Study-Site Metrics

Statistics

Avg # Days from Document Sent to Document Received

Average number of days between Document Sent date and Document Received Date

M-SST24.1

Study-Site Metrics

Statistics

Avg Duration of All Discrepancies

For all discrepancies ever open at a study-site, the average number of days they were open.

M-SST29

Study-Site Metrics

Statistics

Avg Duration of Closed Discrepancies

For those discrepancies that are closed, the average number of days from creation to Closed.

M-SST24

Study-Site Metrics

Statistics

Avg Duration of Currently Open Discrepancies

For all open discrepancies at a study-site, the average number of days open

TA-SUBJ02

Study-Site Metrics

Statistics

Initial Informed Consent Date

Earliest Informed Consent date for a subject

M-SST74

Study-Site Metrics

Statistics

Latest Site Visit Completed Date

Most recent of all Site Visit Completed Dates for a Site

M-SST75

Study-Site Metrics

Statistics

Latest Site Visit Start Date

Most recent of all Site Visit Completed Dates for a Site

M-SST101

Study-Site Metrics

Statistics

Latest Site Visit Type

Visit type of the most recent of all Site Visit Completed Dates for a Site

M-SST45

Study-Site Metrics

Statistics

Latest Subject Completed Date

Most recent date on which a subject completed the study

M-SST24.3

Study-Site Metrics

Statistics

Max Duration of All Discrepancies

For all discrepancies ever open at a study-site, the maximum number of days they were open.

M-SST31

Study-Site Metrics

Statistics

Max Duration of Closed Discrepancies

For all closed discrepancies at a study-site, the maximum number of days it took to close them.

M-SST28

Study-Site Metrics

Statistics

Max Duration of Currently Open Discrepancies

For all discrepancies currently open, the maximum number of days any of them has been open.

M-SST24.2

Study-Site Metrics

Statistics

Min Duration of All Discrepancies

For all discrepancies ever open at a study-site, the minimum number of days they were open.

M-SST30

Study-Site Metrics

Statistics

Min Duration of Closed Discrepancies

For all closed discrepancies at a study-site, the minimum number of days it took to close them.

M-SST27

Study-Site Metrics

Statistics

Min Duration of Currently Open Discrepancies

For all open discrepancies at a study-site, the minimum number of days open

M-SST78

Study-Site Metrics

Statistics

Next Site Visit Date

Earliest Site Visit with Start Visit after today.

M-SST100

Study-Site Metrics

Statistics

Next Site Visit Type

Visit type of the Earliest Site Visit with Start Visit after today.

TA-SUBJ04

Subject Metrics

Actual Milestones

1st Visit Date

The date of the first post-enrollment visit for the subject.

TA-SUBJ09

Subject Metrics

Actual Milestones

[Last Visit Date]

The Last Visit Date for the Subject.

TA-SUBJ05

Subject Metrics

Actual Milestones

Latest Visit Date

The Latest Visit Date for the Subject.

TA-SUBJ06

Subject Metrics

Subject Visits

# Subject Visits Completed

The number of subject visits that have been completed.

TA-SUBJ07

Subject Metrics

Subject Visits

# Subject Visits Overdue

The number of subject visits that have been planned up to today's date but have not been completed.

TA-SUBJ08

Subject Metrics

Subject Visits

# Subject Visits Planned

The number of subject visits planned after today's date.

TA-SUBJ03

Subject Metrics

Transactional Data

Current Status Comment

Subject Status Comments

TA-SUBJ01

Subject Metrics

Transactional Data

Current Subject Status

Subject Status

TA-SUBJ10

Subject Metrics

Transactional Data

SDV Required

Indicates whether or not Source Data Verification (SDV) is required for the subject.

M-SBVT03

Subject Visit

Subject Visits

Subject Visit Completed Date

The Subject Visit Completed Date.

M-SBVT04

Subject Visit

Subject Visits

Subject Visit Completed Flag

Indicates whether the Subject Visit was completed.

M-SBVT05

Subject Visit

Subject Visits

Subject Visit Description

The Subject Visit Description.

M-SBVT06

Subject Visit

Subject Visits

Subject Visit Due Date

The Subject Visit Due Date.

M-SBVT07

Subject Visit

Subject Visits

Subject Visit Max Due Date

The maximum date on which the subject visit would be due.

M-SBVT08

Subject Visit

Subject Visits

Subject Visit Min Due Date

The minimum date on which the subject visit would be due.

M-SBVT09

Subject Visit

Subject Visits

Subject Visit Planned Date

The Subject Visit Planned Date

M-SBVT10

Subject Visit

Subject Visits

Subject Visit Protocol Deviation

Indicates whether there is a protocol deviation on the subject visit.

M-SBVT11

Subject Visit

Subject Visits

Subject Visit Protocol Violation

Indicates whether there is a protocol violation on the subject visit.

M-SBVT12

Subject Visit

Subject Visits

Subject Visit Sequence

The Subject Visit Sequence.

M-SBVT13

Subject Visit

Subject Visits

Subject Visit Template Version

The Subject Visit Template Version.

M-SBVT14

Subject Visit

Subject Visits

Subject Visit Type

The Subject Visit Type.

M-TA10

Therapeutic Area Metrics

Counts

# Studies

The number of study records.

M-TA27

Therapeutic Area Metrics

Medians

Median # Days Between Site Visits

The median of the following cycle time across all site visits for a Therapeutic Area: number of days between consecutive Site Visit Start Dates for completed site visits.

M-TA16

Therapeutic Area Metrics

Medians

[Median # Protocol Amendments per Study]

The median of the number of protocol amendments that occurred for all studies in a Therapeutic Area.

M-TA25

Therapeutic Area Metrics

Medians

[Median 1st Site Initiated to Last Site Initiated (# Days)]

The median of the following cycle time across all studies in a Therapeutic Area: 1st Site Initiated for Date Study to Last Site Initiated Date for Study.

M-TA03

Therapeutic Area Metrics

Medians

Median 1st Site Initiated to Latest Site Initiated (# Days)

The median of the following cycle time across all studies in a Therapeutic Area: 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study.

M-TA22

Therapeutic Area Metrics

Medians

[Median Critical Document Package Complete to Site Initiated (# Days)]

The median of the following cycle time across all Study-Sites in a Therapeutic Area: Critical Document Package Completed Date to Site Initiated Date.

M-TA05

Therapeutic Area Metrics

Medians

Median Initial IRB/EC Approval to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Therapeutic Area: Initial IRB/EC Approval Date to 1st Subject Visit Date.

M-TA06

Therapeutic Area Metrics

Medians

Median Initial IRB/EC Approval to Site Initiated (# Days)

The median of the following cycle time across all Study-Sites in a Therapeutic Area: Initial IRB/EC Approval Date to Site Initiated Date.

M-TA26

Therapeutic Area Metrics

Medians

[Median Last Subject Last Visit to Database Lock (# Days)]

The median of the following cycle time across all studies in a Therapeutic Area: Last Subject Last Visit Date for Study to Database Lock Date.

M-TA07

Therapeutic Area Metrics

Medians

[Median Protocol Approved to 1st Site Initiated (# Days)]

The median of the following cycle time across all studies for Therapeutic Area: Protocol Approved Date to 1st Site Initiated Date for Study.

M-TA08

Therapeutic Area Metrics

Medians

[Median Protocol Approved to 1st Subject Enrolled (# Days)]

The median of the following cycle time across all studies in a Therapeutic Area: Protocol Approved Date to 1st Subject Enrolled Date for Study.

M-TA24

Therapeutic Area Metrics

Medians

[Median Protocol Approved to 1st Subject Randomized (# Days)]

The median of the following cycle time across all studies in a Therapeutic Area: Protocol Approved Date to 1st Subject Randomized Date for Study.

M-TA23

Therapeutic Area Metrics

Medians

[Median Protocol Approved to 1st Subject Screened (# Days)]

The median of the following cycle time across all studies in a Therapeutic Area: Protocol Approved Date to 1st Subject Screened Date for Study.

M-TA09

Therapeutic Area Metrics

Medians

Median Site Initiated to 1st Subject Visit (# Days)

The median of the following cycle time across all Study-Sites in a Therapeutic Area: Site Initiated for Study-Site to 1st Subject Visit Date for Study-Site.

M-TA11

Therapeutic Area Metrics

Medians

Median Site Visit Completed to Follow Up Item Completed (# Days)

The median of the following cycle time across all completed site visits in a Therapeutic Area: Site Visit Completed Date to Follow Up Item Completed Date.

M-TA12

Therapeutic Area Metrics

Medians

Median Site Visit Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits for a Therapeutic Area: Site Visit Completed Date to Visit Report Approved Date.

M-TA13

Therapeutic Area Metrics

Medians

Median Site Visit Completed to Visit Report Completed (# Days)

The median of the following cycle time across all completed site visits for a Therapeutic Area: Site Visit Completed Date to Visit Report Completed Date.

M-TA14

Therapeutic Area Metrics

Medians

Median Site Visit Start to Site Visit Completed (# Days)

The median of the following cycle time across all completed site visits for a Therapeutic Area: Site Visit Start Date to Site Visit Completed Date.

M-TA15

Therapeutic Area Metrics

Medians

Median Visit Report Completed to Visit Report Approved (# Days)

The median of the following cycle time across all completed site visits in a Therapeutic Area: Visit Report Completed Date to Visit Report Approved Date.

M-TA20

Therapeutic Area Metrics

Ratios

% Sites Recruiting 0 Subjects

The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Therapeutic Area.

M-TA21

Therapeutic Area Metrics

Ratios

% Sites Recruiting 1 or More Subjects

the number of sites recruiting one or more Subjects divided by the number of Sites Initiated.

M-TA01

Therapeutic Area Metrics

Ratios

% Sites Recruiting at Least 90% of Planned Subjects

the number of sites recruiting at least 90% of planned subjects divided by the number of Sites Initiated.

TA-SUBJ11

Subject Metrics

Transactional Data

SDV Last Updated Source

Indicates the source that last populated SDV Required field.

M-STD115

Study Metrics

Counts

# Initial Subjects SDV

The initial number of subjects for the Study-Site that will be selected for Source Data Verification (SDV). This is the default for all Study-Sites in the Study.

M-STD116

Study Metrics

Ratios

% Subjects Auto SDV

The percentage of subjects that will be selected for Source Data Verification (SDV). This is the default for all Study-Sites in the Study.

M-SRG36

Study-Region Metrics

Counts

# Initial Subjects SDV

The initial number of subjects for the Study-Site that will be selected for Source Data Verification (SDV). This is the default for all Study-Sites in the Study-Region.

M-SRG37

Study-Region Metrics

Ratios

% Subjects Auto SDV

The percentage of subjects that will be selected for Source Data Verification (SDV). This is the default for all Study-Sites in the Study-Region.

M-SST110

Study-Site Metrics

-

SDV Policy

The Source Data Verification (SDV) policy for the study-site, whether complete (all subjects SDV) partial (use formula to flag subjects for SDV) or external (SDV is determined by a system that integrates with CTMS).

M-PDSS01

Protocol Deviation (Study-Site)

-

[Action Required]

This describes any action required on the Protocol Deviation.

M-PDSS02

Protocol Deviation (Study-Site)

-

[Closure Date]

The date when the Protocol Deviation was closed

M-PDSS03

Protocol Deviation (Study-Site)

-

[Category]

Internal identifying category for the protocol deviation

M-PDSS04

Protocol Deviation (Study-Site)

-

[Description]

Free-form text description of the deviaIQtion.

M-PDSS05

Protocol Deviation (Study-Site)

-

[ID]

Unique identifier for each protocol deviation that occurred on that particular study. This value must be unique by the Protocol Deviation Source.

M-PDSS06

Protocol Deviation (Study-Site)

-

[Identified Date]

The date when the Protocol Deviation was identified.

M-PDSS07

Protocol Deviation (Study-Site)

-

[Issue Escalation Flag]

Indicates if an escalation has been raised against the protocol deviation.

M-PDSS08

Protocol Deviation (Study-Site)

-

[Level]

The level at which the Protocol Deviation.

M-PDSS09

Protocol Deviation (Study-Site)

-

[Occurence Date]

The date when the Protocol Deviation occurred

M-PDSS10

Protocol Deviation (Study-Site)

-

[Reported By]

The details of who reported the Protocol Deviation

M-PDSS11

Protocol Deviation (Study-Site)

-

[Reported to IRB/IEC Flag]

A flag indicating whether a deviation is reported to IRB Ethics committee

M-PDSS12

Protocol Deviation (Study-Site)

-

[Resolution]

The resolution details of the protocol deviation.

M-PDSS13

Protocol Deviation (Study-Site)

-

[Resolution Date]

The resolution date of the protocol deviation

M-PDSS14

Protocol Deviation (Study-Site)

-

[Severity]

The severity of the Protocol Deviation.

M-PDSS15

Protocol Deviation (Study-Site)

-

[Subcategory]

The sub-category for the Protocol Deviation

M-PDSS16

Protocol Deviation (Study-Site)

-

[Source]

The originating source of the Protocol Deviation.

M-PDSS17

Protocol Deviation (Study-Site)

-

[Study Deviation Class]

The deviation class that a deviation raised belongs to

M-PDSS18

Protocol Deviation (Study-Site)

-

[Subject Auth to Continue Flag]

Flag denoting the authorization for Subject(s) to continue based on Protocol Deviations that have occurred

M-PDSU01

Protocol Deviation (Subject)

-

[Action Required]

This describes any action required on the Protocol Deviation.

M-PDSU02

Protocol Deviation (Subject)

-

[Clinical Review Date]

The date the Protocol Deviation was reviewed by the clinician

M-PDSU03

Protocol Deviation (Subject)

-

[Clinical Review Potential PDAL Flag]

Based on Protocol Deviation review, Yes/No flag depicted depending on whether PD is considered to be a Potential PDAL case

M-PDSU04

Protocol Deviation (Subject)

-

[Clinical Review Status]

Clinical PD Review Status (complete, pending)

M-PDSU05

Protocol Deviation (Subject)

-

[Clinical Reviewer]

Name of the clinician performing the review

M-PDSU06

Protocol Deviation (Subject)

-

[Clinical Team Meeting Date]

Date of clinical team meeting where the discussion and decision for the means of Investigator Notification for protocol deviation cases that could lead to unsafe use of study drug.

M-PDSU07

Protocol Deviation (Subject)

-

[Code]

Internal identifying code for the protocol deviation in the code file.

M-PDSU08

Protocol Deviation (Subject)

-

[Status]

Status of the Protocol Deviation.

M-PDSU09

Protocol Deviation (Subject)

-

[Description]

Free-form text description of the deviation.

M-PDSU10

Protocol Deviation (Subject)

-

[ID]

Unique identifier for each protocol deviation that occurred on that particular study. This value must be unique by the Protocol Deviation Source.

M-PDSU11

Protocol Deviation (Subject)

-

[Identified Date]

The date when the Protocol Deviation was identified.

M-PDSU12

Protocol Deviation (Subject)

-

[Issue Escalation Flag]

Indicates if an escalation has been raised against the protocol deviation.

M-PDSU13

Protocol Deviation (Subject)

-

[Level]

The level at which the Protocol Deviation.

M-PDSU14

Protocol Deviation (Subject)

-

[Occurrence Date]

The date when the Protocol Deviation occurred

M-PDSU15

Protocol Deviation (Subject)

-

[Reported By]

The details of who reported the Protocol Deviation

M-PDSU16

Protocol Deviation (Subject)

-

[Reported to IRB/IEC Flag]

A flag indicating whether a deviation is reported to IRB Ethics committee

M-PDSU17

Protocol Deviation (Subject)

-

[Resolution]

The resolution details of the Protocol Deviation.

M-PDSU18

Protocol Deviation (Subject)

-

[Severity]

The severity of the Protocol Deviation.

M-PDSU19

Protocol Deviation (Subject)

-

[Source]

The originating source of the Protocol Deviation.

M-PDSU20

Protocol Deviation (Subject)

-

[Subcategory]

The sub-category for the Protocol Deviation

M-PDSU21

Protocol Deviation (Subject)

-

[Subject Auth to Continue Flag]

Flag denoting the authorization for Subject(s) to continue based on Protocol Deviations that have occurred

M-PDSU22

Protocol Deviation (Subject)

-

[Clinical Review PD Comments]

Protocol Deviation Review Clinician Review Comments

M-PDSU23

Protocol Deviation (Subject)

-

[Category]

The category for the Protocol Deviation

M-SST109

Study-Site Metrics

Counts

[# Protocol Deviations (Subject)]

The total number of Subject related Protocol Deviations.

TA-SUBJ12

Subject Metrics

Counts

[# Protocol Deviations (Study-Site)]

The total number of Study-Site related Protocol Deviations.

Oracle Clinical Sources for OHSCDA Presentation Catalog

There are two tables in this section:

- Table B-3,Presentation Catalog - Oracle Clinical Sourceslists Oracle Clinical sources for presentation catalog.

- Table B-4, Aliases for Table Names lists the aliases used for table names in Table B-3.

Oracle Clinical Sources

Table B-3 describes how OHSCDA populates each column from an Oracle Clinical database. Each Measure has an ID number, which is provided for cross-reference to other tables in this Appendix. To display the information compactly, Table B-3 uses aliases for table names. Refer to Table B-4 for the correspondence between aliases and table names.

Table B-3 Presentation Catalog - Oracle Clinical Sources

Attribute ID

Source Table/Column

Comments/Details

AD02-02

-

Not sourced from OC

AD02-03

-

Not sourced from OC

AD02-04

-

Not sourced from OC

AD02-05

-

Not sourced from OC

AD02-06

-

Not sourced from OC

AD02-07

-

Not sourced from OC

AD02-08

-

Not sourced from OC

AD02-09

-

Not sourced from OC

AD02-10

-

Not sourced from OC

AD02-11

-

Not sourced from OC

AD02-12

-

Not sourced from OC

AD02-13

-

Not sourced from OC

AD02-14

-

Not sourced from OC

AD02-15

-

Not sourced from OC

AD02-16

-

Not sourced from OC

AD02-17

-

Not sourced from OC

AD02-18

-

Not sourced from OC

AD02-19

-

Not sourced from OC

AD02-20

-

Not sourced from OC

AD02-21

-

Not sourced from OC

AD02-22

-

Not sourced from OC

AD02-23

-

Not sourced from OC

AD02-24

-

Not sourced from OC

AD02-25

-

Not sourced from OC

AD02-26

-

Not sourced from OC

AD02-27

-

Not sourced from OC

AD02-28

-

Not sourced from OC

AD02-29

-

Not sourced from OC

AD02-30

-

Not sourced from OC

AD02-31

-

Not sourced from OC

AD02-32

-

Not sourced from OC

AD02-33

-

Not sourced from OC

AD02-34

-

Not sourced from OC

AD02-35

-

Not sourced from OC

AD02-36

-

Not sourced from OC

AD02-37

-

Not sourced from OC

AD02-38

-

Not sourced from OC

AD02-39

-

Not sourced from OC

AD02-40

-

Not sourced from OC

AD02-41

-

Not sourced from OC

AD02-42

-

Not sourced from OC

AD02-43

-

Not sourced from OC

AD02-44

-

Not sourced from OC

AD02-45

-

Not sourced from OC

AD02-46

-

Not sourced from OC

AD02-47

-

Not sourced from OC

AD02-48

-

Not sourced from OC

AD02-49

-

Not sourced from OC

AD02-50

-

Not sourced from OC

AD02-51

-

Not sourced from OC

AD02-52

-

Not sourced from OC

AD02-53

-

Not sourced from OC

AD02-54

-

Not sourced from OC

AD02-55

-

Not sourced from OC

AD02-56

-

Not sourced from OC

AD02-57

-

Not sourced from OC

AD02-58

-

Not sourced from OC

AD02-59

-

Not sourced from OC

AD02-60

-

Not sourced from OC

AD02-61

-

Not sourced from OC

AD02-62

-

Not sourced from OC

AD02-63

-

Not sourced from OC

AD02-64

-

Not sourced from OC

AD02-65

-

Not sourced from OC

AD02-66

-

Not sourced from OC

AD02-67

-

Not sourced from OC

AD02-68

-

Not sourced from OC

AD02-69

-

Not sourced from OC

AD02-70

-

Not sourced from OC

AD02-71

-

Not sourced from OC

AD02-72

-

Not sourced from OC

AD02-73

-

Not sourced from OC

AD02-74

-

Not sourced from OC

AD02-75

-

Not sourced from OC

AD02-76

-

Not sourced from OC

AD02-77

-

Not sourced from OC

AD02-78

-

Not sourced from OC

AD02-79

-

Not sourced from OC

AD02-80

-

Not sourced from OC

AD02-81

-

Not sourced from OC

AD02-82

-

Not sourced from OC

AD02-83

-

Not sourced from OC

AD02-84

-

Not sourced from OC

AD02-85

-

Not sourced from OC

AD02-86

-

Not sourced from OC

AD02-87

-

Not sourced from OC

AD02-88

-

Not sourced from OC

AD02-89

-

Not sourced from OC

AD02-90

-

Not sourced from OC

AD02-91

-

Not sourced from OC

AD02-92

-

Not sourced from OC

AD02-93

-

Not sourced from OC

AD02-94

-

Not sourced from OC

AD02-95

-

Not sourced from OC

AD02-96

-

Not sourced from OC

AD02-97

-

Not sourced from OC

AD02-98

-

Not sourced from OC

AD02-99

-

Not sourced from OC

AD02-100

-

Not sourced from OC

AD02-101

-

Not sourced from OC

AD02-102

-

Not sourced from OC

AD02-103

-

Not sourced from OC

AD02-104

-

Not sourced from OC

AD02-105

-

Not sourced from OC

AD02-106

-

Not sourced from OC

AD02-107

-

Not sourced from OC

AD02-108

-

Not sourced from OC

AD02-109

-

Not sourced from OC

AD02-110

-

Not sourced from OC

AD02-111

-

Not sourced from OC

AD02-112

-

Not sourced from OC

AD02-113

-

Not sourced from OC

AD02-114

-

Not sourced from OC

AD02-115

-

Not sourced from OC

AD02-116

-

Not sourced from OC

AD02-117

-

Not sourced from OC

AD02-118

-

Not sourced from OC

AD02-119

-

Not sourced from OC

AD02-120

-

Not sourced from OC

AD02-121

-

Not sourced from OC

AD02-122

-

Not sourced from OC

AD02-123

-

Not sourced from OC

AD02-124

-

Not sourced from OC

AD02-125

-

Not sourced from OC

AD02-126

-

Not sourced from OC

AD02-127

-

Not sourced from OC

AD02-128

-

Not sourced from OC

AD02-129

-

Not sourced from OC

AD02-130

-

Not sourced from OC

AD02-131

-

Not sourced from OC

AD02-132

-

Not sourced from OC

AD02-133

-

Not sourced from OC

AD02-134

-

Not sourced from OC

AD02-135

-

Not sourced from OC

AD02-136

-

Not sourced from OC

AD02-137

-

Not sourced from OC

AD02-138

-

Not sourced from OC

AD02-139

-

Not sourced from OC

AD02-140

-

Not sourced from OC

AD02-141

-

Not sourced from OC

AD02-142

-

Not sourced from OC

AD02-143

-

Not sourced from OC

AD02-144

-

Not sourced from OC

AD02-145

-

Not sourced from OC

AD02-146

-

Not sourced from OC

AD02-147

-

Not sourced from OC

AD02-148

-

Not sourced from OC

AD02-149

-

Not sourced from OC

AD02-150

-

Not sourced from OC

AD02-151

-

Not sourced from OC

AD02-152

-

Not sourced from OC

AD02-153

-

Not sourced from OC

AD02-154

-

Not sourced from OC

AD02-155

-

Not sourced from OC

AD02-156

-

Not sourced from OC

AD02-157

-

Not sourced from OC

AD04-01

ocl_regions.continent

where the continent is composed of country, and the country has only one continent. Else null.

AD04-03

os.country and inv.country

-

AD04-04

os.state and inv.country

-

AD04-05

-

Not sourced from OC

AD04-06

os.city and inv.city

-

AD04-07

os.postal_code and inv.postal_code

-

AD05-01

inv.last_name

-

AD05-02

inv.first_name

-

AD05-03

inv.first_name ||' '|| inv.last_name

-

AD05-04

inv.address _line%

catenation of 3 lines

AD05-05

inv.city

-

AD05-06

inv.postal_code

-

AD05-07

inv.state

-

AD05-08

inv.country

-

AD05-09

inv.continent

-

AD05-10

-

Not sourced from OC

AD05-11

-

Not sourced from OC

AD05-12

-

Not sourced from OC

AD05-13

-

Not sourced from OC

AD05-14

-

Not sourced from OC

AD05-15

-

Not sourced from OC

AD05-16

-

Not sourced from OC

AD05-17

-

Not sourced from OC

AD05-18

-

Not sourced from OC

AD05-19

-

Not sourced from OC

AD07-01

pm.product_name

-

AD07-02

-

Not sourced from OC

AD07-03

pm.pm_type_code

-

AD07-04

-

Not sourced from OC

AD07-07

-

Not sourced from OC

AD07-08

-

Not sourced from OC

AD07-09

-

Not sourced from OC

AD08-01

site.name

-

AD08-02

site.state

-

AD08-03

site.country

-

AD08-04

region_components.part_of_region_code

Continent, given country

AD08-05

-

Not sourced from OC

AD08-06

-

Not sourced from OC

AD08-07

site.address_line_1

-

AD08-08

site.address_line_2

-

AD08-09

site.address_line_3

-

AD08-10

site.postal_code

-

AD08-11

-

Not sourced from OC

AD08-12

site.city

-

AD09-01

os.study

-

AD09-02

cs.short_title

-

AD09-03

os.program_code

-

AD09-04

os.project_code

-

AD09-05

-

Not sourced from OC

AD09-06

os.project_code

If all received CRFs have a single Data Capture mode, that is the mode of the study. If mixed, the 'Paper and EDC'; If no data collected, mode is 'Unknown'.

AD09-07

-

Not sourced from OC

AD09-08

-

Not sourced from OC

AD09-09

-

Not sourced from OC

AD09-10

-

Not sourced from OC

AD09-11

-

Not sourced from OC

AD09-12

-

Not sourced from OC

AD09-13

-

Not sourced from OC

AD09-14

-

Not sourced from OC

AD09-15

-

Not sourced from OC

AD09-16

-

Not sourced from OC

AD09-17

-

Not sourced from OC

AD09-18

-

Not sourced from OC

AD09-19

-

Not sourced from OC

AD09-20

-

Not sourced from OC

AD09-22

-

Not sourced from OC

AD09-23

-

Not sourced from OC

AD09-24

-

Not sourced from OC

AD09-25

-

Not sourced from OC

AD09-26

-

Not sourced from OC

AD09-27

-

Not sourced from OC

AD09-28

-

Not sourced from OC

AD09-29

-

Not sourced from OC

AD09-30

-

Not sourced from OC

AD09-31

-

Not sourced from OC

AD09-32

-

Not sourced from OC

AD09-33

-

Not sourced from OC

AD09-34

-

Not sourced from OC

AD09-35

-

Not sourced from OC

AD09-36

-

Not sourced from OC

AD09-38

-

Not sourced from OC

AD09-39

-

Not sourced from OC

AD09-40

-

Not sourced from OC

AD09-41

-

Not sourced from OC

AD09-42

-

Not sourced from OC

AD09-43

-

Not sourced from OC

AD09-44

-

Not sourced from OC

AD09-45

-

Not sourced from OC

AD09-46

-

Not sourced from OC

AD09-47

-

Not sourced from OC

AD09-48

-

Not sourced from OC

AD09-49

-

Not sourced from OC

AD09-50

-

Not sourced from OC

AD09-51

-

Not sourced from OC

AD09-52

-

Not sourced from OC

AD09-53

-

Not sourced from OC

AD09-54

-

Not sourced from OC

AD09-55

-

Not sourced from OC

AD09-56

-

Not sourced from OC

AD09-57

-

Not sourced from OC

AD09-58

-

Not sourced from OC

AD09-59

-

Not sourced from OC

AD09-60

-

Not sourced from OC

AD09-61

-

Not sourced from OC

AD09-62

-

Not sourced from OC

AD09-63

-

Not sourced from OC

AD09-64

-

Not sourced from OC

AD09-65

-

Not sourced from OC

AD09-66

-

Not sourced from OC

AD09-67

-

Not sourced from OC

AD09-68

-

Not sourced from OC

AD09-69

-

Not sourced from OC

AD09-70

-

Not sourced from OC

AD09-71

-

Not sourced from OC

AD09-72

-

Not sourced from OC

AD09-73

-

Not sourced from OC

AD09-74

-

Not sourced from OC

AD10-01

site.name

-

AD10-02

ss.study_site

-

AD10-03

-

Not sourced from OC

AD10-04

cs.study

-

AD10-05

os.program_code

-

AD10-06

os.project_code

-

AD10-07

ep.planned_start_date

-

AD10-08

ep.planned_target_date

-

AD10-10

min(pp.patient_enrollment_date)

-

AD10-22

inv.first_name ||' '|| inv.last_name

-

AD10-24

-

Not sourced from OC

AD10-25

-

If all received CRFs have a single Data Capture mode, that is the mode of the study. If mixed, the 'Paper and EDC'; If no data collected, mode is 'Unknown'.

AD10-26

-

Not sourced from OC

AD10-29

sites.active_flag

Not sourced from OC

AD10-31

-

Not sourced from OC

AD10-32

sites.city

Not sourced from OC

AD10-33

sites.postal_code

Not sourced from OC

AD10-34

sites.address_line_1

Not sourced from OC

AD10-35

sites.address_line_2

Not sourced from OC

AD10-36

sites.address_line_3

Not sourced from OC

AD10-37

-

In Business Model only - concatenation of Study #, Site #, P Investigator Last Name

AD10-38

-

Not sourced from OC

AD10-39

-

Not sourced from OC

AD10-40

cs.study_status_type_code

-

AD10-41

-

Not sourced from OC

AD10-42

-

Not sourced from OC

AD10-43

-

Not sourced from OC

AD10-44

-

Not sourced from OC

AD10-45

-

Not sourced from OC

AD10-46

-

Not sourced from OC

AD10-47

-

Not sourced from OC

AD10-48

-

Not sourced from OC

AD10-49

-

Not sourced from OC

AD10-50

-

Not sourced from OC

AD10-51

-

Not sourced from OC

AD10-52

-

Not sourced from OC

AD10-53

-

Not sourced from OC

AD10-54

-

Not sourced from OC

AD10-55

-

Not sourced from OC

AD10-56

-

Not sourced from OC

AD10-57

-

Not sourced from OC

AD10-58

-

Not sourced from OC

AD10-59

-

Not sourced from OC

AD10-60

-

Not sourced from OC

AD10-61

-

Not sourced from OC

AD10-62

-

Not sourced from OC

AD10-63

-

Not sourced from OC

AD10-64

-

Not sourced from OC

AD10-65

-

Not sourced from OC

AD10-66

-

Not sourced from OC

AD10-67

-

Not sourced from OC

AD10-68

-

Not sourced from OC

AD10-69

-

Not sourced from OC

AD10-70

-

Not sourced from OC

AD10-71

-

Not sourced from OC

AD10-72

-

Not sourced from OC

AD10-73

-

Not sourced from OC

AD10-74

-

Not sourced from OC

AD10-75

-

Not sourced from OC

AD10-76

-

Not sourced from OC

AD10-77

-

Not sourced from OC

AD11-01

cs.study

exclude GLIB

AD11-02

dci.name

-

AD11-03

dci.help_text

-

AD11-04

dci.short_name

-

AD11-05

dcis.dci_id

-

AD12-01

book.name

-

AD12-02

cs.study

exclude GLIB

AD13-01

cs.study

exclude GLIB

AD13-02

proc.name

-

AD13-03

proc.description

-

AD13-04

proc.procedure_type_code

-

AD14-01

-

Not sourced from OC

AD14-02

-

Not sourced from OC

AD14-03

-

Not sourced from OC

AD14-04

-

Not sourced from OC

AD14-05

-

Not sourced from OC

AD14-06

-

Not sourced from OC

AD14-07

-

Not sourced from OC

AD14-08

-

Not sourced from OC

AD14-09

-

Not sourced from OC

AD14-10

-

Not sourced from OC

AD15-01

-

Not sourced from OC

AD15-02

-

Not sourced from OC

AD15-03

-

Not sourced from OC

AD15-04

-

Not sourced from OC

AD15-05

-

Not sourced from OC

AD15-06

-

Not sourced from OC

AD15-07

-

Not sourced from OC

AD15-08

-

Not sourced from OC

AD15-09

-

Not sourced from OC

AD15-10

-

Not sourced from OC

AD15-11

-

Not sourced from OC

AD15-12

-

Not sourced from OC

AD15-13

-

Not sourced from OC

AD15-15

-

Not sourced from OC

AD15-16

-

Not sourced from OC

AD15-17

-

Not sourced from OC

AD15-18

-

Not sourced from OC

AD15-19

-

Not sourced from OC

AD16-01

-

Not sourced from OC

AD16-02

-

Not sourced from OC

AD16-03

-

Not sourced from OC

AD16-04

-

Not sourced from OC

AD16-05

-

Not sourced from OC

AD16-06

-

Not sourced from OC

AD16-07

-

Not sourced from OC

AD16-08

-

Not sourced from OC

AD16-09

-

Not sourced from OC

AD16-10

-

Not sourced from OC

AD16-11

-

Not sourced from OC

AD16-12

-

Not sourced from OC

AD16-13

-

Not sourced from OC

AD16-14

-

Not sourced from OC

AD16-15

-

Not sourced from OC

AD16-16

-

Not sourced from OC

AD17-01

-

Not sourced from OC

AD17-02

-

Not sourced from OC

AD17-03

-

Not sourced from OC

AD17-04

-

Not sourced from OC

AD17-05

-

Not sourced from OC

AD17-06

-

Not sourced from OC

AD17-07

-

Not sourced from OC

AD17-08

-

Not sourced from OC

AD17-09

-

Not sourced from OC

AD17-10

-

Not sourced from OC

AD17-11

-

Not sourced from OC

AD17-12

-

Not sourced from OC

AD17-13

-

Not sourced from OC

AD17-14

-

Not sourced from OC

AD17-15

-

Not sourced from OC

AD17-16

-

Not sourced from OC

AD17-17

-

Not sourced from OC

AD17-18

-

Not sourced from OC

AD17-19

-

Not sourced from OC

AD17-20

-

Not sourced from OC

AD17-21

-

Not sourced from OC

AD17-22

-

Not sourced from OC

AD17-23

-

Not sourced from OC

AD17-24

-

Not sourced from OC

AD17-25

-

Not sourced from OC

AD17-26

-

Not sourced from OC

AD17-27

-

Not sourced from OC

AD17-28

-

Not sourced from OC

AD17-29

-

Not sourced from OC

AD17-30

-

Not sourced from OC

AD17-31

-

Not sourced from OC

AD17-32

-

Not sourced from OC

AD17-33

-

Not sourced from OC

AD17-34

-

Not sourced from OC

AD17-35

-

Not sourced from OC

AD17-36

-

Not sourced from OC

AD17-37

-

Not sourced from OC

AD17-38

-

Not sourced from OC

AD17-39

-

Not sourced from OC

AD17-40

-

Not sourced from OC

AD17-41

-

Not sourced from OC

AD17-42

-

Not sourced from OC

AD17-43

-

Not sourced from OC

AD17-44

-

Not sourced from OC

AD17-45

-

Not sourced from OC

AD17-46

-

Not sourced from OC

AD17-47

-

Not sourced from OC

AD18-01

-

Not sourced from OC

AD18-02

-

Not sourced from OC

AD18-03

-

Not sourced from OC

AD18-04

-

Not sourced from OC

AD18-05

-

Not sourced from OC

AD18-06

-

Not sourced from OC

AD18-07

-

Not sourced from OC

AD18-08

-

Not sourced from OC

AD18-09

-

Not sourced from OC

AD18-10

-

Not sourced from OC

AD18-11

-

Not sourced from OC

AD18-12

-

Not sourced from OC

AD19-01

-

Not sourced from OC

AD19-02

-

Not sourced from OC

AD19-03

-

Not sourced from OC

AD19-04

-

Not sourced from OC

AD19-05

-

Not sourced from OC

AD19-06

-

Not sourced from OC

AD19-07

-

Not sourced from OC

AD19-08

-

Not sourced from OC

AD19-09

-

Not sourced from OC

AD20-01

-

Not sourced from OC

AD20-02

-

Not sourced from OC

AD20-03

-

Not sourced from OC

AD20-04

-

Not sourced from OC

AD20-05

-

Not sourced from OC

AD20-06

-

Not sourced from OC

AD20-07

-

Not sourced from OC

AD20-08

-

Not sourced from OC

AD21-01

-

Not sourced from OC

AD21-02

-

Not sourced from OC

AD21-03

-

Not sourced from OC

AD21-04

-

Not sourced from OC

AD21-05

-

Not sourced from OC

AD21-06

-

Not sourced from OC

AD21-07

-

Not sourced from OC

AD21-08

-

Not sourced from OC

AD21-09

-

Not sourced from OC

AD22-01

-

Not sourced from OC

AD22-02

-

Not sourced from OC

AD22-03

-

Not sourced from OC

AD22-04

-

Not sourced from OC

AD22-05

-

Not sourced from OC

AD22-06

-

Not sourced from OC

AD22-07

-

Not sourced from OC

AD22-08

-

Not sourced from OC

AD22-09

-

Not sourced from OC

AD22-10

-

Not sourced from OC

AD22-11

-

Not sourced from OC

AD22-12

-

Not sourced from OC

AD22-13

-

Not sourced from OC

M-ALL01

-

Not sourced from OC

M-ALL02

-

Not sourced from OC

M-ALL03

-

Not sourced from OC

M-ALL04

-

Not sourced from OC

M-ALL05

-

Not sourced from OC

M-ALL06

-

Not sourced from OC

M-ALL07

-

Not sourced from OC

M-ALL08

-

Not sourced from OC

M-ALL09

-

Not sourced from OC

M-ALL10

-

Not sourced from OC

M-ALL11

-

Not sourced from OC

M-ALL12

-

Not sourced from OC

M-ALL13

-

Not sourced from OC

M-ALL14

-

Not sourced from OC

M-ALL15

-

Not sourced from OC

M-ALL16

-

Not sourced from OC

M-ALL17

-

Not sourced from OC

M-ALL18

-

Not sourced from OC

M-ALL19

-

Not sourced from OC

M-ALL20

-

Not sourced from OC

M-ALL21

-

Not sourced from OC

M-DOC01

-

Not sourced from OC

M-DOC02

-

Not sourced from OC

M-DOC03

-

Not sourced from OC

M-DOC04

-

Not sourced from OC

M-DRS01

derh.discrepancy_rev_status_code

-

M-DRS02

sum(derh.next_status_ts - derh.creation_ts)

For each particular review status (the summation is needed in case the discrepancy enters the review status more than once)

M-DRS03

M-DRS02/(number of discrepancies that occupied a given review status)

-

M-DRS04

(M-DRS02/(number of discrepancies that occupied a given review status)) given currently open discrepancies only

-

M-DSC01

disc

count

M-DSC02

disc

count where not OBSOLETE and not irresolvable

M-DSC03

disc

count where discrepancy_status_code = OBSOLETE or irresolvable

M-DSC04

disc

count where disc.dcf_id is not null

M-DSC09

disc

count where irresolvable

M-DSC11

disc

close date - creation date given State = CLOSED; last ETL date - creation date given State = OPEN

M-DSC12

disc

last ETL date - creation date given State = OPEN

M-DSC15

close date - creation date

where State = CLOSED

M-FUI01

-

Not sourced from OC

M-FUI02

-

Not sourced from OC

M-FUI03

-

Not sourced from OC

M-PRG01

-

Not sourced from OC

M-PRG03

-

Not sourced from OC

M-PRG04

-

Not sourced from OC

M-PRG06

-

Not sourced from OC

M-PRG07

-

Not sourced from OC

M-PRG08

-

Not sourced from OC

M-PRG09

-

Not sourced from OC

M-PRG10

-

Not sourced from OC

M-PRG11

-

Not sourced from OC

M-PRG12

-

Not sourced from OC

M-PRG13

-

Not sourced from OC

M-PRG14

-

Not sourced from OC

M-PRG15

-

Not sourced from OC

M-PRG16

-

Not sourced from OC

M-PRG17

-

Not sourced from OC

M-PRG18

-

Not sourced from OC

M-PRG19

-

Not sourced from OC

M-PRG20

-

Not sourced from OC

M-PRG21

-

Not sourced from OC

M-PRG22

-

Not sourced from OC

M-PRG23

-

Not sourced from OC

M-PRG24

-

Not sourced from OC

M-RCF01

rdci.received_dcis

count where required entry passes are complete. For eCRF, this is Pass 1. For pCRF, it is Pass 1 unless second pass is required for the study.

M-RCF05

rdci

where received_dci_status_code = 'RECEIVED'

M-RCF06

rdci

where received_dci_status_code = 'PASS 1 STARTED

M-RCF07

rdci

count where PASS 1 COMPLETE

M-RCF08

rdci

where RECEIVED or PASS 1 STARTED

M-RCF09

rdci

where BLANK_FLAG = 'Y'

M-RCF10

rdci

count

M-RCF11

rdci

last ETL - log_in_ts, where RECEIVED

M-RCF13

rdci

count where rdci.received_dci_status_code in ('PASS 2 STARTED', 'PASS 2 PENDING')

M-RCF14

rdci

count where rdci.received_dci_status_code = 'PASS 2 COMPLETE'

M-RCF15

rdci

count where rdci.received_dci_status_code = 'PASS 2 PENDING'

M-RCF16

rdci

count where rdci.received_dci_status_code in ('PASS 1 COMPLETE', 'PASS 2 STARTED', 'PASS 2 PENDING')

M-RCF17

rdci

count where: rdci is paper (i.e. substr(rdci.document_number, 1,1) != 'R') and either received_dci_status_code = 'PASS 1 STARTED', if PASS 2 not required, or received_dci_status_code in ( 'PASS 1 COMPLETE', 'PASS 2 STARTED', 'PASS 2 PENDING')

M-RCF18

rdci

count where: (rdci is paper (i.e. substr(rdci.document_number, 1,1) != 'R') and either received_dci_status_code = 'PASS 1 STARTED', if PASS 2 not required, or received_dci_status_code in ( 'PASS 1 COMPLETE', 'PASS 2 STARTED', 'PASS 2 PENDING')) or /* eCRF */ received_dci_status_code = 'PASS 1 STARTED')

M-RCF19

rdci

count where received_dci_status_code = 'BATCH'

M-RCF20

rh

count where trans_type = 'SYS VER YES'

M-RCF21

rh

count where trans_type in ('SYS VER NO', 'SYS VER UNDONE', 'SYS VER DATACHG)

M-RCF21.1

rh

count where trans_type in ('SYS APP NO', 'SYS APP UNDONE', 'SYS APP DATACHG')

M-RCF22

rh

count where trans_type = 'SYS VER DATACHG'

M-RCF23

rh

count where trans_type = 'SYS VER NO', ' SYS VER UNDONE'

M-RCF24

rh

count where trans_type = 'SYS APP YES'

M-RCF25

rh

count where trans_type = ('SYS APP NO', 'SYS APP UNDONE')

M-RCF26

rh

count where trans_type = 'SYS APP DATACHG'

M-RCF29

rdci

count all received DCIs that are locked (data_lock_flag = 'Y') but not yet frozen (freeze_flag = 'N')

M-RCF29.1

rdci

count where TA-RCRF28 is 'Y'

M-RCF30

rh

interval from first verification to latest approval, using trans_type

M-RCF31

rdci

-

M-RCF31.1

rdci

ENTRY_COMPLETE_DT - ACTL_SUBJ_VIST_DT

M-RCF32

rdci

pass2_compltn_dt - pass1_compltn_dt

M-RCF33

rdci

for pCRFs in studies requiring pass 2 entry only. If pass 2 complete, then pass2_compltn_dt - pass1_compltn_dt; else LAST_ETL_DT - pass1_compltn_dt.

M-RCF34

rdci

ENTRY_COMPLETE_DT - ACTL_SUBJ_VIST_DT

M-RCF35

rh

for eCRFs only: Date of first verification that is not undone - PASS1_COMPLTN_DT

M-RCF36

rh

for eCRFs only: Date of first approval that is not undone - PASS1_COMPLTN_DT

M-RCF37

rdci

data_lock_ts - ENTRY_COMPLETE_DT

M-RCF38

rh

for eCRFs only: data_lock_ts - Date of latest approval

M-RCF39

rdci

for eCRFs only: pass1_compltn_dt - ACTL_SUBJ_VIST_DT

M-RCF40

rh

for eCRFs only: data_lock_dt - actl_subj_vist_dt

M-RCF41

rdci

avg(M-RCF39)

M-RCF42

rdci

avg(M-RCF31)

M-RCF43

rdci

avg(M-RCF32)

M-RCF44

rdci

avg(M-RCF33)

M-RCF45

rdci

avg(M-RCF34) for eCRFs

M-RCF45.1

rdci

avg(M-RCF34) for pCRFs

M-RCF46

rdci

avg(M-RCF35)

M-RCF47

rdci

avg(M-RCF36)

M-RCF48

rdci

M-RCF30/M-RCF71

M-RCF49

rdci

avg(M-RCF40)

M-RCF49.1

rdci

avg(M-RCF76)

M-RCF49.2

rdci

avg(M-RCF37)

M-RCF50

rdci

avg(M-RCF38)

M-RCF52

rdci

100 * M-RCF20/M-RCF75

M-RCF52.1

rdci

100 * M-RCF24/M-RCF75

M-RCF55.1

rdci

100 * M-RCF24/M-RCF01

M-RCF55.2

rdci

100 * M-RCF20/M-RCF01

M-RCF58

rdci

100 * M-RCF72 /M-RCF75

M-RCF62

rdci

100 * M-RCF29/M-RCF1

M-RCF62.1

rdci

100 * M-RCF72/M-RCF64.3

M-RCF62.2

rdci

100 * M-RCF74/M-RCF78

M-RCF63

rdci

100 * M-RCF22/M-RCF20

M-RCF64

rdci

100 * M-RCF26l/M-RCF24

M-RCF64.1

rdci

100 * M-RCF29/M-RCF75

M-RCF64.2

rdci

100 * (M-RCF74 + M-RCRF74.1)/M-RCF64.3

M-RCF64.3

rdci

100 * M-RCF71.1/M-RCF64.3

M-RCF64.4

rdci

100 * M-RCF74.1/M-RCF78

M-RCF65

rdci

100 * M-RCF1/M-RCF10

M-RCF68

rdci

count where eCRF and received_dci_status_code = 'PASS 1 COMPLETE'

M-RCF69

rdci

count where at least one non-undone verification has occurred.

M-RCF70

rdci

count where at least one non-undone approval has occurred.

M-RCF71.1

-

-

M-RCF72

rdci

count all DCIs received via RDC that are locked (data_lock_flag = 'Y') but not yet frozen (freeze_flag = 'N')

M-RCF73

rdci

pCRFs requiring pass 2 entry only: count where received_dci_status_code = 'PASS 1 COMPLETE'

M-RCF74

rdci

count all received paper DCIs that are locked (data_lock_flag = 'Y') but not yet frozen (freeze_flag = 'N')

M-RCF74.1

rdci

pCRFs only: count where TA-RCRF28 is 'Y'

M-RCF75

rdci

eCRFs only: count *

M-RCF76

rdci

For pCRFs:data_lock_ts - ENTRY_COMPLETE_DT

M-RCF77

rdci

Avg(Pass 1 complete dt - ACTL_SUBJ_VIST_DT)

M-RCF78

rdci

for pCRFs: count where ENTRY-COMPLETE

M-RCF81

rdci

eCRFs only: count where blank_flag = 'Y'

M-RCF82

rdci

pCRFs only: count where blank_flag = 'Y'

M-RCF83

rdci

-

M-RCF84

rdci

eCRFs only: count where subevent_number > 0

M-RCF85

rdci

pCRFs only: count where subevent_number > 0

M-RCF86

rdci

eCRFs only: count where received_dci_status_code = 'PASS 1 STARTED'

M-REG05

-

Not sourced from OC

M-REG07

-

Not sourced from OC

M-REG09

-

Not sourced from OC

M-REG10

-

Not sourced from OC

M-REG11

-

Not sourced from OC

M-REG12

-

Not sourced from OC

M-REG14

-

Not sourced from OC

M-REG15

-

Not sourced from OC

M-REG16

-

Not sourced from OC

M-REG17

-

Not sourced from OC

M-REG18

-

Not sourced from OC

M-REG19

-

Not sourced from OC

M-REG20

-

Not sourced from OC

M-SBVT03

-

Not sourced from OC

M-SBVT04

-

Not sourced from OC

M-SBVT05

-

Not sourced from OC

M-SBVT06

-

Not sourced from OC

M-SBVT07

-

Not sourced from OC

M-SBVT08

-

Not sourced from OC

M-SBVT09

-

Not sourced from OC

M-SBVT10

-

Not sourced from OC

M-SBVT11

-

Not sourced from OC

M-SBVT12

-

Not sourced from OC

M-SBVT13

-

Not sourced from OC

M-SBVT14

-

Not sourced from OC

M-SIV01

-

Not sourced from OC

M-SIV02

-

Not sourced from OC

M-SIV03

-

Not sourced from OC

M-SIV04

-

Not sourced from OC

M-SIV05

-

Not sourced from OC

M-SIV06

-

Not sourced from OC

M-SIV07

-

Not sourced from OC

M-SIV08

-

Not sourced from OC

M-SIV10

-

Not sourced from OC

M-SRG01

-

Not sourced from OC

M-SRG02

-

Not sourced from OC

M-SRG03

-

Not sourced from OC

M-SRG04

-

Not sourced from OC

M-SRG05

-

Not sourced from OC

M-SRG06

-

Not sourced from OC

M-SRG07

-

Not sourced from OC

M-SRG08

-

Not sourced from OC

M-SRG09

-

Not sourced from OC

M-SRG10

-

Not sourced from OC

M-SRG11

-

Not sourced from OC

M-SRG12

-

Not sourced from OC

M-SRG13

-

Not sourced from OC

M-SRG14

-

Not sourced from OC

M-SRG16

-

Not sourced from OC

M-SRG23

-

Not sourced from OC

M-SRG24

-

Not sourced from OC

M-SRG25

-

Not sourced from OC

M-SRG26

-

Not sourced from OC

M-SRG27

-

Not sourced from OC

M-SRG28

-

Not sourced from OC

M-SRG29

-

Not sourced from OC

M-SRG30

-

Not sourced from OC

M-SRG31

-

Not sourced from OC

M-SRG32

-

Not sourced from OC

M-SRG33

-

Not sourced from OC

M-SRG34

-

Not sourced from OC

M-SST01

ep.planned_patient_enrollment

-

M-SST02

pp

count(*) where .patient_enrollment_date is not null and screening_position_flag = 'N'

M-SST02C

-

-

M-SST03

pp

Calculate as # Subjects Enrolled - (# Early Terminations + # Subjects Lost to Follow up)

M-SST04

pp

Calculate as # Subjects Enrolled - (# Early Terminations + # Subjects Lost to Follow up + # Subjects Completed)

M-SST05

pp

A subject who has completed the study is one with an entry in patient_statuses with status of "COMPLETE"

M-SST05C

-

-

M-SST06

pp

An early terminator is one with an entry in patient_statuses with status of "EARLY TERM"

M-SST06C

-

-

M-SST08

ae

count actual events where sub-event number is 0.

M-SST09

ae

count actual events where sub-event number > 0.

M-SST15.1

-

100* (M-SST2/M-SST1)

M-SST17

-

M-DSC2/M-RCF10

M-SST18

-

M-DSC1/M-RCF10

M-SST19

-

M-DSC3/M-RCF10

M-SST20

-

M-DSC2/M-SST2

M-SST21

-

M-DSC1/M-SST2

M-SST23

-

M-DSC3/M-RCF10

M-SST24

-

M-DSC11/M-DSC2

M-SST24.1

-

(M-DSC11+M-DSC15)/(M-DSC2+M-DSC3)

M-SST24.2

-

min(min(M-DSC11), min(M-DSC15))

M-SST24.3

-

max(max(M-DSC11), max(M-DSC15))

M-SST27

-

min(M-DSC11)

M-SST28

-

max(M-DSC11)

M-SST29

-

M-DSC15/M-DSC3

M-SST30

-

min(M-DSC15)

M-SST31

-

max(M-DSC15)

M-SST32

-

Not sourced from OC

M-SST32C

-

Not sourced from OC

M-SST33

-

Not sourced from OC

M-SST33C

-

Not sourced from OC

M-SST34

-

Not sourced from OC

M-SST34C

-

Not sourced from OC

M-SST35

-

Not sourced from OC

M-SST35C

-

Not sourced from OC

M-SST36

-

Not sourced from OC

M-SST37

-

Not sourced from OC

M-SST38

-

Not sourced from OC

M-SST39

-

Not sourced from OC

M-SST40

-

Not sourced from OC

M-SST41

-

Not sourced from OC

M-SST42

-

Not sourced from OC

M-SST43

-

Not sourced from OC

M-SST44

-

Not sourced from OC

M-SST45

-

Not sourced from OC

M-SST46

-

Not sourced from OC

M-SST47

-

Not sourced from OC

M-SST48

-

Not sourced from OC

M-SST49

-

Not sourced from OC

M-SST50

-

Not sourced from OC

M-SST51

-

Not sourced from OC

M-SST52

-

Not sourced from OC

M-SST54

-

Not sourced from OC

M-SST55

-

Not sourced from OC

M-SST56

-

Not sourced from OC

M-SST57

-

Not sourced from OC

M-SST58

-

Not sourced from OC

M-SST59

-

Not sourced from OC

M-SST60

-

Not sourced from OC

M-SST61

-

Not sourced from OC

M-SST62

-

Not sourced from OC

M-SST63

-

Not sourced from OC

M-SST65

-

Not sourced from OC

M-SST66

-

Not sourced from OC

M-SST67

-

Not sourced from OC

M-SST68

-

Not sourced from OC

M-SST69

-

Not sourced from OC

M-SST70

-

Not sourced from OC

M-SST71

-

Not sourced from OC

M-SST72

-

Not sourced from OC

M-SST73

-

Not sourced from OC

M-SST74

-

Not sourced from OC

M-SST75

-

Not sourced from OC

M-SST76

-

Not sourced from OC

M-SST77

-

Not sourced from OC

M-SST78

-

Not sourced from OC

M-SST79

-

Not sourced from OC

M-SST80

-

Not sourced from OC

M-SST81

-

Not sourced from OC

M-SST82

-

Not sourced from OC

M-SST83

-

Not sourced from OC

M-SST84

-

Not sourced from OC

M-SST85

-

Not sourced from OC

M-SST86

-

Not sourced from OC

M-SST87

-

Not sourced from OC

M-SST88

-

Not sourced from OC

M-SST89

-

Not sourced from OC

M-SST90

-

Not sourced from OC

M-SST91

-

Not sourced from OC

M-SST92

-

Not sourced from OC

M-SST93

-

Not sourced from OC

M-SST94

-

Not sourced from OC

M-SST95

-

Not sourced from OC

M-SST96

-

Not sourced from OC

M-SST97

-

Not sourced from OC

M-SST98

-

Not sourced from OC

M-SST99

-

Not sourced from OC

M-SST100

-

Not sourced from OC

M-SST101

-

Not sourced from OC

M-SST102

-

Not sourced from OC

M-SST103

-

Not sourced from OC

M-SST104

-

Not sourced from OC

M-SST105

-

Not sourced from OC

M-SST106

-

Not sourced from OC

M-SST107

-

Not sourced from OC

M-STD01

ep

count (*) where plan_sub_type_code = 'SITE'

M-STD02

csv, ep

For a given study, first look at the number of patients to enroll in the live study version to determine planned enrollment for that study. If that is null, use study enrollment plan

M-STD06

-

100 * # Enrolled/# Enrollments Planned

M-STD07

-

Not sourced from OC

M-STD08

-

Not sourced from OC

M-STD09

-

Not sourced from OC

M-STD10

-

Not sourced from OC

M-STD11

-

Not sourced from OC

M-STD12

-

Not sourced from OC

M-STD13

-

Not sourced from OC

M-STD14

-

Not sourced from OC

M-STD15

-

Not sourced from OC

M-STD16

-

Not sourced from OC

M-STD17

-

Not sourced from OC

M-STD18

-

Not sourced from OC

M-STD20

-

Not sourced from OC

M-STD21

-

Not sourced from OC

M-STD22

-

Not sourced from OC

M-STD23

-

Not sourced from OC

M-STD24

-

Not sourced from OC

M-STD25

-

Not sourced from OC

M-STD26

-

Not sourced from OC

M-STD27

-

Not sourced from OC

M-STD28

-

Not sourced from OC

M-STD29

-

Not sourced from OC

M-STD30

-

Not sourced from OC

M-STD31

-

Not sourced from OC

M-STD32

-

Not sourced from OC

M-STD40

-

Not sourced from OC

M-STD42

-

Not sourced from OC

M-STD43

-

Not sourced from OC

M-STD44

-

Not sourced from OC

M-STD45

-

Not sourced from OC

M-STD46

-

Not sourced from OC

M-STD47

-

Not sourced from OC

M-STD48

-

Not sourced from OC

M-STD49

-

Not sourced from OC

M-STD50

-

Not sourced from OC

M-STD51

-

Not sourced from OC

M-STD52

-

Not sourced from OC

M-STD53

-

Not sourced from OC

M-STD54

-

Not sourced from OC

M-STD55

-

Not sourced from OC

M-STD56

-

Not sourced from OC

M-STD57

-

Not sourced from OC

M-STD58

-

Not sourced from OC

M-STD59

-

Not sourced from OC

M-STD60

-

Not sourced from OC

M-STD61

-

Not sourced from OC

M-STD62

-

Not sourced from OC

M-STD63

-

Not sourced from OC

M-STD64

-

Not sourced from OC

M-STD65

-

Not sourced from OC

M-STD66

-

Not sourced from OC

M-STD67

-

Not sourced from OC

M-STD68

-

Not sourced from OC

M-STD69

-

Not sourced from OC

M-STD70

-

Not sourced from OC

M-STD71

-

Not sourced from OC

M-STD72

-

Not sourced from OC

M-STD73

-

Not sourced from OC

M-STD74

-

Not sourced from OC

M-STD75

-

Not sourced from OC

M-STD76

-

Not sourced from OC

M-STD77

-

Not sourced from OC

M-STD78

-

Not sourced from OC

M-STD79

-

Not sourced from OC

M-STD80

-

Not sourced from OC

M-STD81

-

Not sourced from OC

M-STD82

-

Not sourced from OC

M-STD83

-

Not sourced from OC

M-STD84

-

Not sourced from OC

M-STD85

-

Not sourced from OC

M-STD86

-

Not sourced from OC

M-STD87

-

Not sourced from OC

M-STD88

-

Not sourced from OC

M-STD89

-

Not sourced from OC

M-STD90

-

Not sourced from OC

M-STD91

-

Not sourced from OC

M-STR01

-

Not sourced from OC

M-STR02

-

Not sourced from OC

M-STR03

-

Not sourced from OC

M-STR04

-

Not sourced from OC

M-STR05

-

Not sourced from OC

M-STR06

-

Not sourced from OC

M-STR07

-

Not sourced from OC

M-STR08

-

Not sourced from OC

M-STR09

-

Not sourced from OC

M-STR10

-

Not sourced from OC

M-STR11

-

Not sourced from OC

M-STR12

-

Not sourced from OC

M-STR13

-

Not sourced from OC

M-STR14

-

Not sourced from OC

M-STR15

-

Not sourced from OC

M-STR16

-

Not sourced from OC

M-STR17

-

Not sourced from OC

M-STR18

-

Not sourced from OC

M-STR19

-

Not sourced from OC

M-STR20

-

Not sourced from OC

M-STR21

-

Not sourced from OC

M-STR22

-

Not sourced from OC

M-STR23

-

Not sourced from OC

M-STR24

-

Not sourced from OC

M-STR25

-

Not sourced from OC

M-STR26

-

Not sourced from OC

M-STR27

-

Not sourced from OC

M-STR28

-

Not sourced from OC

M-STR29

-

Not sourced from OC

M-STR30

-

Not sourced from OC

M-STR31

-

Not sourced from OC

M-STR32

-

Not sourced from OC

M-STR33

-

Not sourced from OC

M-STR34

-

Not sourced from OC

M-STR35

-

Not sourced from OC

M-STR36

-

Not sourced from OC

M-STR37

-

Not sourced from OC

M-STR38

-

Not sourced from OC

M-TA01

-

Not sourced from OC

M-TA03

-

Not sourced from OC

M-TA05

-

Not sourced from OC

M-TA06

-

Not sourced from OC

M-TA07

-

Not sourced from OC

M-TA08

-

Not sourced from OC

M-TA09

-

Not sourced from OC

M-TA10

-

Not sourced from OC

M-TA11

-

Not sourced from OC

M-TA12

-

Not sourced from OC

M-TA13

-

Not sourced from OC

M-TA14

-

Not sourced from OC

M-TA15

-

Not sourced from OC

M-TA16

-

Not sourced from OC

M-TA20

-

Not sourced from OC

M-TA21

-

Not sourced from OC

M-TA22

-

Not sourced from OC

M-TA23

-

Not sourced from OC

M-TA24

-

Not sourced from OC

M-TA25

-

Not sourced from OC

M-TA26

-

Not sourced from OC

M-TA27

-

Not sourced from OC

TA-DISC01

disc.discrepancy_entry_id

-

TA-DISC02

cs.study

where cs.clinical_study_id = disc.clinical_study_id

TA-DISC03

os.name

where os.site_id = disc.site_id

TA-DISC04

inv

inv.last_name, inv.first_name where inv.investigator_id = disc.investigator_id

TA-DISC05

pp.patient

-

TA-DISC06

cpe.name

-

TA-DISC07

cpe.visit_number

-

TA-DISC08

disc.subevent_number

-

TA-DISC09

cpe.visit_number || '.' || disc.subevent_number where cpe.clin_plan_eve_id = disc.clin_plan_eve_id

-

TA-DISC10

rcdi.dci_date

-

TA-DISC11

rcdi.log_in_ts

-

TA-DISC12

dci.dci_id

-

TA-DISC13

disc.CRF_PAGE_NUMBER

-

TA-DISC14

dcm.name

-

TA-DISC15

dqg.name

-

TA-DISC16

dq.question_name

-

TA-DISC17

dq.occurrence_sn

-

TA-DISC19

disc.discrepancy_rev_status_code

where DISC_IRRESOLVABLE

TA-DISC20

proc.name

-

TA-DISC21

disc.DISCREPANCY_REV_STATUS_CODE

-

TA-DISC22

disc.discrepancy_rev_status_code

-

TA-DISC22.1

disc.discrepancy_rev_status_code

where STATE = 'CLOSED'

TA-DISC23

disc.DE_SUB_TYPE_CODE

-

TA-DISC24

discrepancy_entries.discrepancy_resolu_type_code

-

TA-DISC25

disc.creation_ts

-

TA-DISC26

disc

Date discrepancy STATE became CLOSED.

TA-DISC26.1

disc.DE_SUB_TYPE_CODE

Not sourced from OC

TA-DISC30

disc.comment_text

-

TA-DISC31

disc

Y' if disc.discrepancy_entry_id in (select discrepancy_id from dcf_discrepancies)

TA-DISC32

-

case disc.de_sub_type_code in ('MANUAL','MANUAL HEADER') then 'Non-System' else 'System' end origin

TA-DISC33

ss.study_site

where ss.SITE_ID = disc.site_id and ss.CLINICAL_STUDY_ID = disc.CLINICAL_STUDY_ID

TA-DOC01

-

Not sourced from OC

TA-DOC02

-

Not sourced from OC

TA-DOC03

-

Not sourced from OC

TA-DOC04

-

Not sourced from OC

TA-DOC05

-

Not sourced from OC

TA-DOC06

-

Not sourced from OC

TA-DOC07

-

Not sourced from OC

TA-DOC08

-

Not sourced from OC

TA-DOC09

-

Not sourced from OC

TA-FUI01

-

Not sourced from OC

TA-FUI02

-

Not sourced from OC

TA-FUI03

-

Not sourced from OC

TA-FUI04

-

Not sourced from OC

TA-FUI05

-

Not sourced from OC

TA-FUI06

-

Not sourced from OC

TA-FUI07

-

Not sourced from OC

TA-FUI08

-

Not sourced from OC

TA-RCRF01

rdci.document_id

-

TA-RCRF02

cs.study

where cs.clinical_study_id = rdci.clinical_study_id

TA-RCRF03

os.name

where os.site_id = rdci.site_id

TA-RCRF04

inv

first_name || ' ' || last_name

TA-RCRF05

pp.patient

-

TA-RCRF06

rdci.clin_plan_eve_name

-

TA-RCRF07

cpe.visit_number

-

TA-RCRF08

rdci.subevent_number

-

TA-RCRF09

rdci.visit_number, subevent_number

-

TA-RCRF10

rdci.dci_date

-

TA-RCRF11

rdci.dci_id

-

TA-RCRF12

book.name

-

TA-RCRF13

page.start_page_number

-

TA-RCRF14

rdci.received_dci_login_ts

-

TA-RCRF15

rdci.received_dci_status_code

-

TA-RCRF16

rdci.received_dci_id

case when rdcih.trans_type in 'SYS VER NO', 'SYS VER UNDONE') then 'Y' else 'N'

TA-RCRF17

rdci.received_dci_id

case when rdcih.trans_type ='SYS VER DATACHG' then 'Y' else 'N'

TA-RCRF19

rdci.received_dci_id

case when rdcih.trans_type in 'SYS APP NO', 'SYS APP UNDONE') then 'Y' else 'N'

TA-RCRF20

select rdci.received_dci_id,

case when rdcih.trans_type ='SYS APP DATACHG' then 'Y' else 'N'

TA-RCRF22

rdci.blank_flag

-

TA-RCRF23

rdci.data_lock_flag

-

TA-RCRF24

rdci

when rdci.received_dci_status_code in 'RECEIVED', 'PASS 1 STARTED') then 'Y' else 'N' end

TA-RCRF25

rdci

case when rdci.received_dci_status_code in 'PASS 1 COMPLETE', 'PASS 2 STARTED', 'PASS 2 PENDING') then 'Y' else 'N' end

TA-RCRF26

-

ENTRY_COMPLETE

TA-RCRF28

book.name

A received DCI is hard locked if the patient position for which that received DCI is collected has been frozen. Freezing the patient position means all of that patient position's received dcis are hard-locked. So we use pp.freeze_flag as hard-lock flag

TA-RCRF29

rdci.data_lock_ts

-

TA-RCRF30

rdci

Date of first non-undone verification, using rh.

TA-RCRF31

rdci.received_dci_status_code

Date of most recent non-undone verification, using rh.

TA-RCRF32

rdci

Date of first non-undone approval using rh.

TA-RCRF33

rdci

Date of most recent non-undone approval using rh.

TA-RCRF34

-

-

TA-RCRF35

-

see eCRF, pCRF

TA-SITE01

-

Not sourced from OC

TA-SIV01

-

Not sourced from OC

TA-SIV02

-

Not sourced from OC

TA-SIV03

-

Not sourced from OC

TA-SIV04

-

Not sourced from OC

TA-SIV05

-

Not sourced from OC

TA-SIV06

-

Not sourced from OC

TA-SIV07

-

Not sourced from OC

TA-SIV08

-

Not sourced from OC

TA-SIV09

-

Not sourced from OC

TA-SIV10

-

Not sourced from OC

TA-SIV11

-

Not sourced from OC

TA-SUBJ01

-

Not sourced from OC

TA-SUBJ02

-

Not sourced from OC

TA-SUBJ03

-

Not sourced from OC

TA-SUBJ04

-

Not sourced from OC

TA-SUBJ05

-

Not sourced from OC

TA-SUBJ06

-

Not sourced from OC

TA-SUBJ07

-

Not sourced from OC

TA-SUBJ08

-

Not sourced from OC

TA-SUBJ09

-

Not sourced from OC

TD01-01

pp.clinical_study_id

-

TD01-02

pp.patient

-

TD01-03

pp.dci_book_id

-

TD01-04

pp.freeze_flag

-

TD01-05

pp.early_termination_flag

-

TD01-06

ps, pp

icase when ps.patient_status_code ='ENROLLED' then ps.status_date when pp.patient_enrollment_date is not null then pp.patient_enrollment_date else null end

TD01-07

pp

Case when <TD01-06> is not null then 'Y' else 'N' end

TD01-08

pp.reported_initials

-

TD01-09

pp.reported_birth_date

-

TD01-10

pp.reported_death_date

-

TD01-11

ps

Use the latest status code for the subject

TD01-12

ps,pp

case when ps.patient_status_code ='COMPLETE' then ps.status_date when pp.termination_date is not null and pp.early_termination_flag != 'Y' then pp.termination_date else null end

TD01-16

pp.reported_sex

-

TD01-17

-

Not sourced from OC

TD01-18

-

Not sourced from OC

TD01-19

-

Not sourced from OC

TD01-20

-

Not sourced from OC

TD01-21

-

Not sourced from OC

TD01-22

-

Not sourced from OC

TD01-23

-

Not sourced from OC

TD01-24

-

Not sourced from OC

TD01-25

-

Not sourced from OC

TD01-26

-

Not sourced from OC

TD01-27

-

Not sourced from OC

TD01-28

-

Not sourced from OC

TD01-29

-

Not sourced from OC

TD01-30

-

Not sourced from OC

AD09-75

S_CL_PTCL_LS.OBJECTIVE_DESC

Not sourced from OC

AD09-76

S_ASSESS. ASSESS_TMPL_NAME

Not sourced from OC

AD09-77

S_ASSESS. LAST_UPD

Not sourced from OC

AD09-78

S_ASSESS. NAME

Not sourced from OC

AD09-79

S_ASSESS.DESC_TEXT

Not sourced from OC

AD09-81

-

Not sourced from OC

AD09-82

-

Not sourced from OC

AD09-83

-

Not sourced from OC

AD09-84

-

Not sourced from OC

AD09-85

-

Not sourced from OC

AD09-86

-

Not sourced from OC

AD09-87

-

Not sourced from OC

AD09-88

-

Not sourced from OC

AD10-78

S_PTCL_SITE_LS. MAX_ENROLLMENT

Not sourced from OC

AD10-79

S_ASSESS. ASSESS_TMPL_NAME

Not sourced from OC

AD10-80

S_ASSESS. LAST_UPD

Not sourced from OC

AD10-81

S_ASSESS. NAME

Not sourced from OC

AD10-82

S_PTCL_SITE_LS. SDV_TYPE_CD

Not sourced from OC

AD10-82

S_PTCL_SITE_LS. SDV_TYPE_CD

Not sourced from OC

AD16-17

S_ASSESS. ASSESS_TMPL_NAME

Not sourced from OC

AD16-18

S_ASSESS. LAST_UPD

Not sourced from OC

AD16-19

S_ASSESS. NAME

Not sourced from OC

AD16-20

S_ASSESS.DESC_TEXT

Not sourced from OC

AD16-21

S_ASSESS. SCORE

Not sourced from OC

AD17-48

S_ASSESS. ASSESS_TMPL_NAME

Not sourced from OC

AD17-49

S_ASSESS. LAST_UPD

Not sourced from OC

AD17-50

S_ASSESS. NAME

Not sourced from OC

AD17-51

S_ASSESS.DESC_TEXT

Not sourced from OC

AD18-13

-

Not sourced from OC

AD18-14

-

Not sourced from OC

AD18-15

-

Not sourced from OC

AD18-16

-

Not sourced from OC

AD18-17

-

Not sourced from OC

AD18-18

-

Not sourced from OC

AD18-19

-

Not sourced from OC

AD18-20

-

Not sourced from OC

AD18-21

-

Not sourced from OC

AD18-22

-

Not sourced from OC

AD23-01

-

Not sourced from OC

AD23-02

-

Not sourced from OC

AD23-03

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from OC

Note: This column is a concatenation of Category + : + Question. For this measure source only the substring before the first ": " If field does not have a ":" or begins with a ":", then use the category "No Category".

AD23-04

-

Not sourced from OC

AD23-05

-

Not sourced from OC

AD23-07

-

Not sourced from OC

M-PRR01

-

Not sourced from OC

M-PRR02

-

Not sourced from OC

M-PRR03

-

Not sourced from OC

M-PRR04

S_ASSESS_VAL .SCORE

Not sourced from OC

M-PRR05

S_ASSESS_VAL .COMMENTS

Not sourced from OC

M-PRR06

S_ASSESS_VAL .SEQUENCE_NUM

Not sourced from OC

M-PRR07

-

Not sourced from OC

M-PRR08

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from OC

M-PRR09

-

Not sourced from OC

M-PRR10

Impact (M-PRR04)

Not sourced from OC

M-PRR11

S_ASSESS_VAL . WEIGHT

Not sourced from OC

M-PRR12

Avg of child question scores

Not sourced from OC

M-PTL01

S_PTCL_VER_LS. AMND_VERSION

Not sourced from OC

M-PTL02

S_PTCL_VER_LS. VER_CREATED_DT

Not sourced from OC

M-PTL03

S_PTCL_VER_LS. ORIG_VER_FLG

Not sourced from OC

M-PTL04

-

Not sourced from OC

M-PTL05

-

Not sourced from OC

M-PTL06

S_PTCL_VER_LS. COMMENTS

Not sourced from OC

M-SDR01

-

Not sourced from OC

M-SDR02

-

Not sourced from OC

M-SDR03

-

Not sourced from OC

M-SDR04

S_ASSESS_VAL . SCORE

Not sourced from OC

M-SDR05

S_ASSESS_VAL .COMMENTS

Not sourced from OC

M-SDR06

S_ASSESS_VAL .SEQUENCE_NUM

Not sourced from OC

M-SDR07

-

Not sourced from OC

M-SDR08

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from OC

M-SDR09

-

Not sourced from OC

M-SDR10

Impact (M-SDR04)

Not sourced from OC

M-SDR11

S_ASSESS_VAL . WEIGHT

Not sourced from OC

M-SDR12

Avg of child question scores

Not sourced from OC

M-SRG36

S_CL_PTCL_LS.INIT_NUM_OF_SUBJ

Not sourced from OC

M-SRG37

S_CL_PTCL_LS. SEL_CL_SUBJ_PCT

Not sourced from OC

M-SRR01

-

Not sourced from OC

M-SRR02

-

Not sourced from OC

M-SRR03

-

Not sourced from OC

M-SRR04

S_ASSESS_VAL . SCORE

Not sourced from OC

M-SRR05

S_ASSESS_VAL .COMMENTS

Not sourced from OC

M-SRR06

S_ASSESS_VAL .SEQUENCE_NUM

Not sourced from OC

M-SRR07

-

Not sourced from OC

M-SRR08

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from OC

M-SRR09

-

Not sourced from OC

M-SRR10

Impact (M-SRR04)

Not sourced from OC

M-SRR11

S_ASSESS_VAL . WEIGHT

Not sourced from OC

M-SRR12

Avg of child question scores

Not sourced from OC

M-SSR01

-

Not sourced from OC

M-SSR02

-

Not sourced from OC

M-SSR03

-

Not sourced from OC

M-SSR04

S_ASSESS_VAL . SCORE

Not sourced from OC

M-SSR05

S_ASSESS_VAL .COMMENTS

Not sourced from OC

M-SSR06

S_ASSESS_VAL .SEQUENCE_NUM

Not sourced from OC

M-SSR07

-

Not sourced from OC

M-SSR08

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from OC

M-SSR09

-

Not sourced from OC

M-SSR10

Impact (M-SSR04)

Not sourced from OC

M-SSR11

S_ASSESS_VAL . WEIGHT

Not sourced from OC

M-SSR12

Avg of child question scores

Not sourced from OC

M-SST107

S_PTCL_SITE_LS.INIT_NUM_OF_SUBJ

Not sourced from OC

M-SST108

S_PTCL_SITE_LS. SEL_CL_SUBJ_PCT

Not sourced from OC

M-STD100

-

Not sourced from OC

M-STD101

-

Not sourced from OC

M-STD102

-

Not sourced from OC

M-STD103

-

Not sourced from OC

M-STD104

-

Not sourced from OC

M-STD105

-

Not sourced from OC

M-STD106

-

Not sourced from OC

M-STD107

-

Not sourced from OC

M-STD108

-

Not sourced from OC

M-STD109

-

Not sourced from OC

M-STD110

-

Not sourced from OC

M-STD111

-

Not sourced from OC

M-STD112

-

Not sourced from OC

M-STD113

-

Not sourced from OC

M-STD114

-

Not sourced from OC

Count of all versions of a protocol that are not the original version that have been flagged as avoidable.

M-STD115

S_CL_PTCL_LS.INIT_NUM_OF_SUBJ

Not sourced from OC

M-STD116

S_CL_PTCL_LS.SEL_CL_SUBJ_PCT

Not sourced from OC

M-STD93

-

Not sourced from OC

M-STD94

-

Not sourced from OC

M-STD95

-

Not sourced from OC

M-STD96

-

Not sourced from OC

M-STD97

-

Not sourced from OC

M-STD98

-

Not sourced from OC

M-STD99

-

Not sourced from OC

TA-SIV12

S_EVT_ACT_LSX. REVIEWED_TS

Not sourced from OC

TA-SIV13

S_EVT_ACT_LSX. REVIEW_COMMENTS

Not sourced from OC

TA-SIV14

Employee Last, First Name; Join on S_EVT_ACT_LSX. REVIEWER_ID

Not sourced from OC

TA-SIV15

Employee Last, First Name; Join on S_EVT_ACT_LSX. APPROVER_ID

Not sourced from OC

TA-SUBJ10

S_CL_SUBJ_LS.

Not sourced from OC

TA-SUBJ11

S_CL_SUBJ_LS .SDV_UPD_TYPE_CD

Not sourced from OC

Aliases

To display the information compactly, Table B-3 uses aliases for table names. Table B-4 lists these aliases:

Table B-4 Aliases for Table Names

Alias

Table Name

book

rxc.dci_books

cpe

rxa_des.clinical_planned_events

cs

rxa_des.clinical_studies

dci

rxc.dcis

derh

rxc.discrepancy_review_hist

disc

rxc.discrepancy_entries

dq

rxc.dcm_questions

dqg

rxc.dcm_question_groups

ep

rxa_des.enrollment_plans

inv

rxa_des.ocl_investigators

os

rxa_des.ocl_studies

page

rxc.dci_book_pages

pp

rxa_des.patient_positions

pm

rxa_des.ocl_product_masters

proc

rxc.procedures

ps

rxa_des.patient_statuses

rcv

rxc.reference_codelist_values

rdci

rxc.received_dcis

rdcm

rxc.received_dcms

site

rxa_des.ocl_sites

ss

rxa_des.ocl_study_sites

Caution:
Where source location is described in snippets of SQL code, it should be read as an indication of how the information is to be extracted. This is typically not the actual code used in the OC-specific ETL programs. Consult the ETL for actual extraction queries.

Note that:

- eCRF is distinguished from pCRF by the first character in the document ID. If this is 'R', the document is assumed to be entered through RDC, and therefore an eCRF. Otherwise, it is considered to be an eCRF.

- ACTL_SUBJ_VIST_DT is the date when the RDCI was collected. This is taken to be the first non-null of these: rdci.visit_date; min(rdcm.visit_date) for the rdci; min(rdci.visit_date) for the rdci's visit; min(rdcm.visit_date) for the rdci's visit.

- ENTRY_COMPLETE: an eCRF is entry complete if it is pass 1 complete; a pCRF is entry complete if either (a) pass 2 is required and it is pass 2 complete, or (b) it is pass 1 complete.

- ENTRY_COMPLETE_DT is the date when RDCI became ENTRY_COMPLETE.

- LAST_ETL_DT is the date when the ETL was last executed.

- All queries on received_dcis look only at records where end_ts = to_date(3000000, 'J')

- A discrepancy is DISC_IRRESOLVABLE if disc.discrepancy_rev_status_code in (select rcv.ref_codelist_value_short_val from reference_codelist_values rcv where rcv.ref_codelist_name = 'DISCREPANCY REV STATUS CODE' and rcv.long_value = 'IRRESOLVABLE');

- A discrepancy's STATE is CLOSED {DISCREPANCY_REV_STATUS_CODE is 'CLOSED', or DISCREPANCY_STATUS_CODE = 'OBSOLETE', or DISC_IRRESOLVABLE). OPEN otherwise.

Oracle's Siebel Clinical Sources for OHSCDA Presentation Catalog

Table B-5 describes how OHSCDA populates each column from an Siebel Clinical (SC) database. Each Measure has an ID number, which is provided for cross-reference to other tables in this Appendix.

Table B-5 Presentation Catalog - Siebel Clinical Sources

Attribute ID

Source Table/Column

Comments/Details

AD02-02

-

Not sourced from SC

AD02-03

-

Not sourced from SC

AD02-04

-

Not sourced from SC

AD02-05

-

Not sourced from SC

AD02-06

-

Not sourced from SC

AD02-07

-

Not sourced from SC

AD02-08

-

Not sourced from SC

AD02-09

-

Not sourced from SC

AD02-10

-

Not sourced from SC

AD02-11

-

Not sourced from SC

AD02-12

-

Not sourced from SC

AD02-13

-

Not sourced from SC

AD02-14

-

Not sourced from SC

AD02-15

-

Not sourced from SC

AD02-16

-

Not sourced from SC

AD02-17

-

Not sourced from SC

AD02-18

-

Not sourced from SC

AD02-19

-

Not sourced from SC

AD02-20

-

Not sourced from SC

AD02-21

-

Not sourced from SC

AD02-22

-

Not sourced from SC

AD02-23

-

Not sourced from SC

AD02-24

-

Not sourced from SC

AD02-25

-

Not sourced from SC

AD02-26

-

Not sourced from SC

AD02-27

-

Not sourced from SC

AD02-28

-

Not sourced from SC

AD02-29

-

Not sourced from SC

AD02-30

-

Not sourced from SC

AD02-31

-

Not sourced from SC

AD02-32

-

Not sourced from SC

AD02-33

-

Not sourced from SC

AD02-34

-

Not sourced from SC

AD02-35

-

Not sourced from SC

AD02-36

-

Not sourced from SC

AD02-37

-

Not sourced from SC

AD02-38

-

Not sourced from SC

AD02-39

-

Not sourced from SC

AD02-40

-

Not sourced from SC

AD02-41

-

Not sourced from SC

AD02-42

-

Not sourced from SC

AD02-43

-

Not sourced from SC

AD02-44

-

Not sourced from SC

AD02-45

-

Not sourced from SC

AD02-46

-

Not sourced from SC

AD02-47

-

Not sourced from SC

AD02-48

-

Not sourced from SC

AD02-49

-

Not sourced from SC

AD02-50

-

Not sourced from SC

AD02-51

-

Not sourced from SC

AD02-52

-

Not sourced from SC

AD02-53

-

Not sourced from SC

AD02-54

-

Not sourced from SC

AD02-55

-

Not sourced from SC

AD02-56

-

Not sourced from SC

AD02-57

-

Not sourced from SC

AD02-58

-

Not sourced from SC

AD02-59

-

Not sourced from SC

AD02-60

-

Not sourced from SC

AD02-61

-

Not sourced from SC

AD02-62

-

Not sourced from SC

AD02-63

-

Not sourced from SC

AD02-64

-

Not sourced from SC

AD02-65

-

Not sourced from SC

AD02-66

-

Not sourced from SC

AD02-67

-

Not sourced from SC

AD02-68

-

Not sourced from SC

AD02-69

-

Not sourced from SC

AD02-70

-

Not sourced from SC

AD02-71

-

Not sourced from SC

AD02-72

-

Not sourced from SC

AD02-73

-

Not sourced from SC

AD02-74

-

Not sourced from SC

AD02-75

-

Not sourced from SC

AD02-76

-

Not sourced from SC

AD02-77

-

Not sourced from SC

AD02-78

-

Not sourced from SC

AD02-79

-

Not sourced from SC

AD02-80

-

Not sourced from SC

AD02-81

-

Not sourced from SC

AD02-82

-

Not sourced from SC

AD02-83

-

Not sourced from SC

AD02-84

-

Not sourced from SC

AD02-85

-

Not sourced from SC

AD02-86

-

Not sourced from SC

AD02-87

-

Not sourced from SC

AD02-88

-

Not sourced from SC

AD02-89

-

Not sourced from SC

AD02-90

-

Not sourced from SC

AD02-91

-

Not sourced from SC

AD02-92

-

Not sourced from SC

AD02-93

-

Not sourced from SC

AD02-94

-

Not sourced from SC

AD02-95

-

Not sourced from SC

AD02-96

-

Not sourced from SC

AD02-97

-

Not sourced from SC

AD02-98

-

Not sourced from SC

AD02-99

-

Not sourced from SC

AD02-100

-

Not sourced from SC

AD02-101

-

Not sourced from SC

AD02-102

-

Not sourced from SC

AD02-103

-

Not sourced from SC

AD02-104

-

Not sourced from SC

AD02-105

-

Not sourced from SC

AD02-106

-

Not sourced from SC

AD02-107

-

Not sourced from SC

AD02-108

-

Not sourced from SC

AD02-109

-

Not sourced from SC

AD02-110

-

Not sourced from SC

AD02-111

-

Not sourced from SC

AD02-112

-

Not sourced from SC

AD02-113

-

Not sourced from SC

AD02-114

-

Not sourced from SC

AD02-115

-

Not sourced from SC

AD02-116

-

Not sourced from SC

AD02-117

-

Not sourced from SC

AD02-118

-

Not sourced from SC

AD02-119

-

Not sourced from SC

AD02-120

-

Not sourced from SC

AD02-121

-

Not sourced from SC

AD02-122

-

Not sourced from SC

AD02-123

-

Not sourced from SC

AD02-124

-

Not sourced from SC

AD02-125

-

Not sourced from SC

AD02-126

-

Not sourced from SC

AD02-127

-

Not sourced from SC

AD02-128

-

Not sourced from SC

AD02-129

-

Not sourced from SC

AD02-130

-

Not sourced from SC

AD02-131

-

Not sourced from SC

AD02-132

-

Not sourced from SC

AD02-133

-

Not sourced from SC

AD02-134

-

Not sourced from SC

AD02-135

-

Not sourced from SC

AD02-136

-

Not sourced from SC

AD02-137

-

Not sourced from SC

AD02-138

-

Not sourced from SC

AD02-139

-

Not sourced from SC

AD02-140

-

Not sourced from SC

AD02-141

-

Not sourced from SC

AD02-142

-

Not sourced from SC

AD02-143

-

Not sourced from SC

AD02-144

-

Not sourced from SC

AD02-145

-

Not sourced from SC

AD02-146

-

Not sourced from SC

AD02-147

-

Not sourced from SC

AD02-148

-

Not sourced from SC

AD02-149

-

Not sourced from SC

AD02-150

-

Not sourced from SC

AD02-151

-

Not sourced from SC

AD02-152

-

Not sourced from SC

AD02-153

-

Not sourced from SC

AD02-154

-

Not sourced from SC

AD02-155

-

Not sourced from SC

AD02-156

-

Not sourced from SC

AD02-157

-

Not sourced from SC

AD04-01

-

Not sourced from SC

AD04-03

-

Not sourced from SC

AD04-04

-

Not sourced from SC

AD04-05

-

Not sourced from SC

AD04-06

-

Not sourced from SC

AD04-07

-

Not sourced from SC

AD05-01

S_CONTACT.LAST_NAME

-

AD05-02

S_CONTACT.FST_NAME

-

AD05-03

S_CONTACT.LAST_NAME + S_CONTACT.FST_NAME

-

AD05-04

S_ADDR_PER.ADDR

-

AD05-05

S_ADDR_PER.CITY

-

AD05-06

S_ADDR_PER.ZIPCODE

-

AD05-07

S_ADDR_PER.STATE

-

AD05-08

S_ADDR_PER.COUNTRY

-

AD05-09

-

Not sourced from SC

AD05-10

S_CONTACT.WORK_PH_NUM

-

AD05-11

-

Not sourced from SC

AD05-12

S_CONTACT.CELL_PH_NUM

-

AD05-13

S_CONTACT.EMAIL_ADDR

-

AD05-14

S_CONTACT.FAX_PH_NUM

-

AD05-15

S_CONTACT.MID_NAME

-

AD05-16

S_CONTACT.CON_CD

-

AD05-17

S_ADDR_PER.ADDR_LINE_2

-

AD05-18

S_ADDR_PER.ADDR_LINE_3

-

AD05-19

S_CONTACT_ROW_ID

-

AD07-01

S_PROD_INT.NAME

-

AD07-02

S_PROD_INT.TYPE

-

AD07-03

-

Not sourced from SC

AD07-04

S_PROD_INT.DESC_TEXT

-

AD07-07

S_PROD_INT.PART_NUM

-

AD07-08

S_PROD_INT.STATUS_CD

-

AD07-09

S_PROD_INT.ROW_ID

-

AD08-01

S_ORG_EXT.NAME

-

AD08-02

S_ADDR_PER.STATE

S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID

AD08-03

S_ADDR_PER.COUNTRY

S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID

AD08-04

-

Not sourced from SC

AD08-05

S_BU.NAME

S_ORG_EXT.BU_ID = S_BU.PAR_ROW_ID

AD08-06

S_ORG_EXT.ID

-

AD08-07

S_ADDR_PER.ADDR

S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID

AD08-08

S_ADDR_PER.ADDR_LINE_2

S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID

AD08-09

S_ADDR_PER.ADDR_LINE_3

S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID

AD08-10

S_ADDR_PER.ZIPCODE

S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID

AD08-11

S_ADDR_PER.COUNTY

S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID

AD08-12

S_ADDR_PER.CITY

S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID

AD09-01

S_CL_PTCL_LS.PTCL_NUM

-

AD09-02

S_CL_PTCL_LS.PTCL_ABBR_TL

-

AD09-03

S_CL_PGM_LS.NAME

-

AD09-04

-

Not sourced from SC

AD09-05

-

Not sourced from SC

AD09-06

-

Not sourced from SC

AD09-07

S_CL_PTCL_LS.PTCL_COMP_AGNT

-

AD09-08

S_CL_PTCL_LS.PTCL_DIAGNOSIS

-

AD09-09

S_CL_PTCL_LS.EUDRA_NUM

-

AD09-10

S_CL_PTCL_LS.PTCL_PHASE

-

AD09-11

S_CL_PTCL_LS.PTCL_STAT_CD

-

AD09-12

S_CL_PTCL_LS.PTCL_TITLE

-

AD09-13

S_CL_PTCL_LS.PTCL_TYPE_CD

-

AD09-14

S_CL_PTCL_LS.DB_LOCK_DT

-

AD09-15

S_CL_PTCL_LS.ROW_ID

-

AD09-16

S_CONTACT.S_CONTACT.LAST_NAME & ', ' & S_CONTACT.FST_NAME

where S_PT_POS_HST_LS.ROLE_CD = "Study Manager'

AD09-17

S_PROD_INT.NAME

-

AD09-18

-

Not sourced from SC

AD09-19

-

Not sourced from SC

AD09-20

-

Not sourced from SC

AD09-22

-

Not sourced from SC

AD09-23

-

Not sourced from SC

AD09-24

-

Not sourced from SC

AD09-25

-

Not sourced from SC

AD09-26

-

Not sourced from SC

AD09-27

-

Not sourced from SC

AD09-28

-

Not sourced from SC

AD09-29

-

Not sourced from SC

AD09-30

-

Not sourced from SC

AD09-31

-

Not sourced from SC

AD09-32

-

Not sourced from SC

AD09-33

-

Not sourced from SC

AD09-34

-

Not sourced from SC

AD09-35

-

Not sourced from SC

AD09-36

-

Not sourced from SC

AD09-38

-

Not sourced from SC

AD09-39

-

Not sourced from SC

AD09-40

-

Not sourced from SC

AD09-41

-

Not sourced from SC

AD09-42

-

Not sourced from SC

AD09-43

-

Not sourced from SC

AD09-44

-

Not sourced from SC

AD09-45

-

Not sourced from SC

AD09-46

-

Not sourced from SC

AD09-47

-

Not sourced from SC

AD09-48

-

Not sourced from SC

AD09-49

-

Not sourced from SC

AD09-50

-

Not sourced from SC

AD09-51

-

Not sourced from SC

AD09-52

-

Not sourced from SC

AD09-53

-

Not sourced from SC

AD09-54

-

Not sourced from SC

AD09-55

-

Not sourced from SC

AD09-56

-

Not sourced from SC

AD09-57

-

Not sourced from SC

AD09-58

-

Not sourced from SC

AD09-59

-

Not sourced from SC

AD09-60

-

Not sourced from SC

AD09-61

-

Not sourced from SC

AD09-62

-

Not sourced from SC

AD09-63

-

Not sourced from SC

AD09-64

-

Not sourced from SC

AD09-65

-

Not sourced from SC

AD09-66

-

Not sourced from SC

AD09-67

-

Not sourced from SC

AD09-68

-

Not sourced from SC

AD09-69

-

Not sourced from SC

AD09-70

-

Not sourced from SC

AD09-71

-

Not sourced from SC

AD09-72

-

Not sourced from SC

AD09-73

-

Not sourced from SC

AD09-74

-

Not sourced from SC

AD10-01

S_ORG_EXT.NAME

-

AD10-02

S_PTCL_SITE_LS.SITE_NUM

-

AD10-03

S_CL_PTCL_LS.REGION_CD

-

AD10-04

S_CL_PTCL_LS.PTCL_NUM

-

AD10-05

S_CL_PGM_LS.NAME

-

AD10-06

-

Not sourced from SC

AD10-07

-

Not sourced from SC

AD10-08

-

Not sourced from SC

AD10-10

S_PTCL_SITE_LS.FST_SUBJ_ENRL_DT

-

AD10-22

S_CONTACT.LAST_NAME+FST_NAME

S_PTL_ST_CON_LS.AFFL_CON_ID=S_CONTACT.PAR_ROW_ID AND RELATION_TYPE_CD ='Principal Investigator'

AD10-24

S_ORG_EXT.NAME

-

AD10-25

-

Not sourced from SC

AD10-26

-

Not sourced from SC

AD10-29

S_PTCL_SITE_LS.STATUS_CD

-

AD10-31

-

Not sourced from SC

AD10-32

S_ADDR_PER.CITY

-

AD10-33

S_ADDR_PER.ZIPCODE

-

AD10-34

S_ADDR_PER.ADDR

-

AD10-35

S_ADDR_PER.ADDR_LINE_2

-

AD10-36

S_ADDR_PER.ADDR_LINE_3

-

AD10-37

-

In Business Model only - concatenation of Study #, Site #, P Investigator Last Name

AD10-38

S_CL_PTCL_LS.PTCL_STAT_CD

REGION_CD NOT NULL

AD10-39

S_PTCL_SITE_LS.ROW_ID

-

AD10-40

S_CL_PTCL_LS.PTCL_STAT_CD

-

AD10-41

S_PTCL_SITE_LS.ST_INITN_CMPL_DT

-

AD10-42

S_CONTACT.S_CONTACT.LAST_NAME & ', ' & S_CONTACT.FST_NAME

where S_ST_POS_HST_LS.ROLE_CD = "CRA"

AD10-43

S_PROD_INT.NAME

-

AD10-44

S_ADDR_PER.COUNTRY

-

AD10-45

S_ADDR_PER.STATE

-

AD10-46

-

Not sourced from SC

AD10-47

-

Not sourced from SC

AD10-48

-

Not sourced from SC

AD10-49

-

Not sourced from SC

AD10-50

-

Not sourced from SC

AD10-51

-

Not sourced from SC

AD10-52

-

Not sourced from SC

AD10-53

-

Not sourced from SC

AD10-54

-

Not sourced from SC

AD10-55

-

Not sourced from SC

AD10-56

-

Not sourced from SC

AD10-57

-

Not sourced from SC

AD10-58

-

Not sourced from SC

AD10-59

-

Not sourced from SC

AD10-60

-

Not sourced from SC

AD10-61

-

Not sourced from SC

AD10-62

-

Not sourced from SC

AD10-63

-

Not sourced from SC

AD10-64

-

Not sourced from SC

AD10-65

-

Not sourced from SC

AD10-66

-

Not sourced from SC

AD10-67

-

Not sourced from SC

AD10-68

-

Not sourced from SC

AD10-69

-

Not sourced from SC

AD10-70

-

Not sourced from SC

AD10-71

-

Not sourced from SC

AD10-72

-

Not sourced from SC

AD10-73

-

Not sourced from SC

AD10-74

S_PTCL_SITE_LS.SITE_TERM_DT

-

AD10-75

-

Not sourced from SC

AD10-76

S_ADDR_PER.LATITUDE

-

AD10-77

S_ADDR_PER.LONGITUDE

-

AD11-01

-

Not sourced from SC

AD11-02

-

Not sourced from SC

AD11-03

-

Not sourced from SC

AD11-04

-

Not sourced from SC

AD11-05

-

Not sourced from SC

AD12-01

-

Not sourced from SC

AD12-02

-

Not sourced from SC

AD13-01

-

Not sourced from SC

AD13-02

-

Not sourced from SC

AD13-03

-

Not sourced from SC

AD13-04

-

Not sourced from SC

AD14-01

S_CONTACT.FST_NAME

-

AD14-02

S_CONTACT.LAST_NAME

-

AD14-03

S_CONTACT.FULL_NAME

-

AD14-04

S_ST_HST_POS_LS.ROLE_CD

-

AD14-05

S_ST_HST_POS_LS.START_DT

-

AD14-06

S_ST_HST_POS_LS.END_DT

-

AD14-07

S_ST_HST_POS_LS.COMMENTS

-

AD14-08

S_CONTACT.ROW_ID

-

AD14-09

-

S_ST_HST_POS_LS.END_DT is null or > today

AD14-10

S_CONTACT.EMAIL_ADDR

-

AD15-01

S_ADDR_PER.CITY

-

AD15-02

S_ADDR_PER.COUNTRY

-

AD15-03

-

Not sourced from SC

AD15-04

S_CONTACT.EMAIL_ADDR

-

AD15-05

S_CONTACT.EMP_FLG

-

AD15-06

S_CONTACT.FAX_PH_NUM

-

AD15-07

S_CONTACT.FST_NAME

-

AD15-08

S_CONTACT.FULL_NAME

-

AD15-09

S_CONTACT.LAST_NAME

-

AD15-10

S_CONTACT.MID_NAME

-

AD15-11

S_CONTACT.CELL_PH_NUM

-

AD15-12

S_CONTACT.WORK_PHONE

-

AD15-13

S_ADDR_PER.ZIPCODE

-

AD15-15

S_ADDR_PER.STATE

-

AD15-16

S_ADDR_PER.ST_ADDRESS

-

AD15-17

S_ADDR_PER.ADDR_LINE_2

-

AD15-18

S_ADDR_PER.ADDR_LINE_3

-

AD15-19

S_CONTACT_ROW_ID

-

AD16-01

S_CL_PGM_LS.DESC_TEXT

-

AD16-02

S_CL_PGM_LS.NAME

-

AD16-03

S_CL_PGM_LS.PROG_MCHNSM_CD

-

AD16-04

S_CL_PGM_LS.ROW_ID

-

AD16-05

-

Not sourced from SC

AD16-06

-

Not sourced from SC

AD16-07

-

Not sourced from SC

AD16-08

-

Not sourced from SC

AD16-09

-

Not sourced from SC

AD16-10

-

Not sourced from SC

AD16-11

-

Not sourced from SC

AD16-12

-

Not sourced from SC

AD16-13

-

Not sourced from SC

AD16-14

-

Not sourced from SC

AD16-15

-

Not sourced from SC

AD16-16

-

Not sourced from SC

AD17-01

S_CL_PTCL_LS.REGION_CD

-

AD17-02

S_CL_PTCL_LS.PTCL_STAT_CD

REGION_CD NOT NULL

AD17-03

S_ORG_EXT.NAME

-

AD17-04

S_CL_PTCL_LS_ROW_ID

-

AD17-05

-

Not sourced from SC

AD17-06

-

Not sourced from SC

AD17-07

-

Not sourced from SC

AD17-08

-

Not sourced from SC

AD17-09

-

Not sourced from SC

AD17-10

-

Not sourced from SC

AD17-11

-

Not sourced from SC

AD17-12

-

Not sourced from SC

AD17-13

-

Not sourced from SC

AD17-14

-

Not sourced from SC

AD17-15

-

Not sourced from SC

AD17-16

-

Not sourced from SC

AD17-17

S_CONTACT

LAST_NAME, FST_NAME where S_PT_POS_HST_LS.ROLE_CD = "Region Manager'

AD17-18

-

Not sourced from SC

AD17-19

-

Not sourced from SC

AD17-20

-

Not sourced from SC

AD17-21

-

Not sourced from SC

AD17-22

-

Not sourced from SC

AD17-23

-

Not sourced from SC

AD17-24

-

Not sourced from SC

AD17-25

-

Not sourced from SC

AD17-26

-

Not sourced from SC

AD17-27

-

Not sourced from SC

AD17-28

-

Not sourced from SC

AD17-29

-

Not sourced from SC

AD17-30

-

Not sourced from SC

AD17-31

-

Not sourced from SC

AD17-32

-

Not sourced from SC

AD17-33

-

Not sourced from SC

AD17-34

-

Not sourced from SC

AD17-35

-

Not sourced from SC

AD17-36

-

Not sourced from SC

AD17-37

-

Not sourced from SC

AD17-38

-

Not sourced from SC

AD17-39

-

Not sourced from SC

AD17-40

-

Not sourced from SC

AD17-41

-

Not sourced from SC

AD17-42

-

Not sourced from SC

AD17-43

S_CL_PTCL_LS

REGION_CD

AD17-44

S_CL_PTCL_LS

PTCL_NUM+ "/ " + REGION_CD

AD17-45

-

Not sourced from SC

AD17-46

-

Not sourced from SC

AD17-47

-

Not sourced from SC

AD18-01

-

Not sourced from SC

AD18-02

-

Not sourced from SC

AD18-03

-

Not sourced from SC

AD18-04

-

Not sourced from SC

AD18-05

-

Not sourced from SC

AD18-06

-

Not sourced from SC

AD18-07

-

Not sourced from SC

AD18-08

-

Not sourced from SC

AD18-09

-

Not sourced from SC

AD18-10

-

Not sourced from SC

AD18-11

-

Not sourced from SC

AD18-12

-

Not sourced from SC

AD19-01

S_PT_POS_HST_LS

FST_NAME

AD19-02

S_PT_POS_HST_LS

LAST_NAME

AD19-03

S_PT_POS_HST_LS

[LAST_NAME]+", "+[FST_NAME]

AD19-04

S_PT_POS_HST_LS

ROLE_CD

AD19-05

S_PT_POS_HST_LS

START_DT

AD19-06

S_PT_POS_HST_LS

END_DT

AD19-07

S_PT_POS_HST_LS

EMAIL_ADDR

AD19-08

S_PT_POS_HST_LS

COMMENTS

AD19-09

S_PT_POS_HST_LS

END_DT

AD20-01

-

Not sourced from SC

AD20-02

-

Not sourced from SC

AD20-03

-

Not sourced from SC

AD20-04

-

Not sourced from SC

AD20-05

-

Not sourced from SC

AD20-06

-

Not sourced from SC

AD20-07

S_CL_PTCL_LS

REGION_CD

AD20-08

-

Not sourced from SC

AD21-01

S_PT_POS_HST_LS

FST_NAME

AD21-02

S_PT_POS_HST_LS

LAST_NAME

AD21-03

S_PT_POS_HST_LS

[LAST_NAME]+", "+[FST_NAME]

AD21-04

S_PT_POS_HST_LS

ROLE_CD

AD21-05

S_PT_POS_HST_LS

START_DT

AD21-06

S_PT_POS_HST_LS

END_DT

AD21-07

S_PT_POS_HST_LS

EMAIL_ADDR

AD21-08

S_PT_POS_HST_LS

COMMENTS

AD21-09

S_PT_POS_HST_LS

END_DT

AD22-01

-

Not sourced from SC

AD22-02

-

Not sourced from SC

AD22-03

-

Not sourced from SC

AD22-04

-

Not sourced from SC

AD22-05

-

Not sourced from SC

AD22-06

-

Not sourced from SC

AD22-07

-

Not sourced from SC

AD22-08

-

Not sourced from SC

AD22-09

-

Not sourced from SC

AD22-10

-

Not sourced from SC

AD22-11

-

Not sourced from SC

AD22-12

-

Not sourced from SC

AD22-13

-

Not sourced from SC

M-ALL01

S_CL_SUBJ_ST_LS

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 and st_initn_cmpl_dt is not null group by ptcl_num order by 1

M-ALL02

S_PS_STMPVER_LS

select site_num, irb_apprv_dt "IRB_Approval_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls

where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id

order by 1

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-ALL03

S_CL_PTCL_LS

Protocol Approved Date cannot be sourced. min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT)

M-ALL04

S_CL_PTCL_LS

select ptcl_num, min(status_date) "First_Subj_Enrolled_Date" from s_cl_subj_ls, s_cl_ptcl_ls, S_PTCL_SITE_LS, S_CL_SUBJ_ST_LS where s_cl_subj_ls.PTCL_SITE_ID = S_PTCL_SITE_LS.row_id and S_PTCL_SITE_LS.cl_ptcl_id = s_cl_ptcl_ls.row_id and S_CL_SUBJ_ST_LS.par_subj_id = s_cl_subj_ls.row_id and S_CL_SUBJ_ST_LS.status_cd = 'Enrolled' group by ptcl_num order by 1 Protocol Approved Date cannot be sourced.

M-ALL05

S_CL_SUBJ_ST_LS

STATUS_DATE select ptcl_num, min(status_date) "First_Subj_Randomized_Date" from s_cl_subj_ls, s_cl_ptcl_ls, S_PTCL_SITE_LS, S_CL_SUBJ_ST_LS where s_cl_subj_ls.PTCL_SITE_ID = S_PTCL_SITE_LS.row_id and S_PTCL_SITE_LS.cl_ptcl_id = s_cl_ptcl_ls.row_id and S_CL_SUBJ_ST_LS.par_subj_id = s_cl_subj_ls.row_id and S_CL_SUBJ_ST_LS.status_cd = 'Randomized' group by ptcl_num order by 1 Protocol Approved Date cannot be sourced.

M-ALL06

S_CL_SUBJ_ST_LS

STATUS_DATE select ptcl_num, min(status_date) "First_Screen_Date" from s_cl_subj_ls, s_cl_ptcl_ls, S_PTCL_SITE_LS, S_CL_SUBJ_ST_LS where s_cl_subj_ls.PTCL_SITE_ID = S_PTCL_SITE_LS.row_id and S_PTCL_SITE_LS.cl_ptcl_id = s_cl_ptcl_ls.row_id and S_CL_SUBJ_ST_LS.par_subj_id = s_cl_subj_ls.row_id and S_CL_SUBJ_ST_LS.status_cd = 'Screened' group by ptcl_num order by 1 Protocol Approved Date cannot be sourced.

M-ALL07

-

"select site_num, st_initn_cmpl_dt ""Site_Initiation_Date"" from s_ptcl_site_ls order by 1

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'"

M-ALL08

S_EVT_ACT

select cl_ptcl_st_id, TODO_PLAN_START_DT "site_Visit_Start_Date", TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit'

M-ALL09

S_CL_PTCL_LS

select ptcl_num, count(*) from s_cl_ptcl_ls, S_PTCL_VER_LS where s_cl_ptcl_ls.row_id = cl_ptcl_id group by ptcl_num

M-ALL10

S_CL_PTCL_LS

select count(ptcl_num) from s_cl_ptcl_ls

M-ALL11

S_CL_PTCL_LS

Number of sites recruiting one or more subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >=1 group by ptcl_num

M-ALL12

S_CL_SUBJ_ST_LS

Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.NUM_PLAN_SUBJ > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)

M-ALL13

S_CL_PTCL_LS

1st Site Initiate can get from min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) To get LATEST Site Initiated Date, we have to use different table, column: max(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Ex: select max(ST_INITN_CMPL_DT) from S_PTCL_SITE_LS where CL_PTCL_ID = '1-4LOA'

M-ALL14

S_PTCL_SITE_LS.ST_INITN_CMPL_DT

1st site initiated can get from S_PTCL_SITE_LS.ST_INITN_CMPL_DT Ex: select max(ST_INITN_CMPL_DT) from S_PTCL_SITE_LS "Critical Document Package Completed Date" cannot be sourced.

M-ALL15

S_PS_STMPVER_LS S_CL_PTCL_LS

IRB_APPRV_DT select site_num, irb_apprv_dt "IRB_Approval_Date", st_initn_cmpl_dt "Site_Initiation_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls where S_PS_STMPVER_LS.ptcl_site_id = s_ptcl_site_ls.row_id order by 1

M-ALL16

S_EVT_ACT

TODO_ACTL_END_DT select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null

M-ALL17

S_EVT_ACT

TODO_ACTL_END_DT Site visit completed date can get from: select cl_ptcl_st_id, TODO_ACTL_END_DT "Visit_Completed_Date" from s_evt_act where subtype_cd = 'Site Visit' and TODO_ACTL_END_DT is not null Visit report approved date cannot be sourced.

M-ALL18

S_EVT_ACT

Site visit completed date can get from: select cl_ptcl_st_id, TODO_ACTL_END_DT "Site_Visit_Completed_Date", APPT_END_DT "Visit_Rep_Completed_Date" from s_evt_act where subtype_cd = 'Site Visit' and TODO_ACTL_END_DT is not null

M-ALL19

S_EVT_ACT

APPT_END_DT Visit Report Approved date cannot be sourced.

M-ALL20

S_CL_PTCL_LS

1st Site Initiate can get from min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Last cannot be determined, so this cannot be sourced.

M-ALL21

S_CL_PTCL_LS

DB_LOCK_DT Last subject last visit date cannot be sourced. Database Lock date for the protocol can get from: S_CL_PTCL_LS.DB_LOCK_DT

M-DOC01

S_EVT_ACT.ROW_ID

SUBTYPE_CD='Document'

M-DOC02

-

Calculated in RPD based on W_ACTIVITY_F.DOC_EXPIRATION_DT

M-DOC03

-

Calculated in RPD based on W_ACTIVITY_F.DOC_RECEIVED_DT and W_ACTIVITY_F.DOC_SENT_DT

M-DOC04

-

Calculated in RPD based on W_ACTIVITY_F.DOC_RECEIVED_DT

M-DRS01

-

Not sourced from SC

M-DRS02

-

Not sourced from SC

M-DRS03

-

Not sourced from SC

M-DRS04

-

Not sourced from SC

M-DSC01

-

Not sourced from SC

M-DSC02

-

Not sourced from SC

M-DSC03

-

Not sourced from SC

M-DSC04

-

Not sourced from SC

M-DSC09

-

Not sourced from SC

M-DSC11

-

Not sourced from SC

M-DSC12

-

Not sourced from SC

M-DSC15

-

Not sourced from SC

M-FUI01

-

Calculated in RPD based on W_RXI_FOLLOWUP_ITEM_F.FOLLOWUP_ITEM_CMPLT_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT

M-FUI02

-

Calculated in RPD based on W_RXI_FOLLOWUP_ITEM_F.FOLLOWUP_ITEM_CMPLT_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT

M-FUI03

-

Calculated in RPD based on W_RXI_FOLLOWUP_ITEM_F.FOLLOWUP_ITEM_CMPLT_DT

M-PRG01

S_CL_PTCL_LS

select s_cl_pgm_ls.name "Program_Name", min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", max(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "Latest_Site_Initiated_Date" from s_cl_pgm_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id group by s_cl_pgm_ls.name

M-PRG03

-

select s_cl_pgm_ls.name "Program_Name", irb_apprv_dt "IRB_Approval_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS

where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id

order by 1

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_A

CT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-PRG04

S_PS_STMPVER_LS S_PTCL_SITE_LS

IRB_APPRV_DT ST_INITN_CMPL_DT

M-PRG06

-

select s_cl_pgm_ls.name "Program_Name", ptcl_num, min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date" from s_cl_pgm_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id order by 1,2 Protocol Approved Date cannot be sourced.

M-PRG07

-

select s_cl_pgm_ls.name "Program_Name", ptcl_num, min (s_cl_subj_st_ls.status_date) "First Subject Enrolled Date" from s_cl_pgm_ls, s_cl_ptcl_ls where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num order by 1,2 Protocol Approved Date cannot be sourced.

M-PRG08

-

select s_cl_pgm_ls.name "Program_Name", site_num "Site_Number", st_initn_cmpl_dt "Site_Initiation_Date"

from s_ptcl_site_ls, s_cl_ptcl_ls, s_cl_pgm_ls

where s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id and s_ptcl_site_ls.cl_ptcl_id = s_cl_ptcl_ls.row_id

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-PRG09

-

select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null and b.cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where cl_pgm_id in (select row_id from s_cl_pgm_ls where name = 'Anemia')))

M-PRG10

-

Site visit completed date in a program can get from: select s_cl_pgm_ls.name "Program_Name", site_num, TODO_ACTL_END_DT "Site_Visit_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' Visit report approved date cannot be sourced.

M-PRG11

-

select s_cl_pgm_ls.name "Program_Name", TODO_ACTL_END_DT "Site_Visit_Completed_Date", appt_end_dt "Visit_Rep_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null

M-PRG12

-

select s_cl_pgm_ls.name "Program_Name", ptcl_num, site_num, TODO_PLAN_START_DT "Site_Visit_Start_Date", TODO_ACTL_END_DT "Site_Visit_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null

M-PRG13

-

select s_cl_pgm_ls.name "Program_Name", ptcl_num, site_num, appt_end_dt "Visit_Rep_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null Visit Report Approved Date cannot be sourced.

M-PRG14

-

select ptcl_num, count(*) from s_cl_ptcl_ls, S_PTCL_VER_LS where s_cl_ptcl_ls.row_id = cl_ptcl_id group by ptcl_num

M-PRG15

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num order by 1

M-PRG16

-

select count(ptcl_num) from s_cl_ptcl_ls

M-PRG17

-

Number of sites recruiting one or more subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num

M-PRG18

-

Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and NUM_ENROLLED > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)

M-PRG19

S_PTCL_SITE_LS

ST_INITN_CMPL_DT Critical Document package Completed Date cannot be sourced

M-PRG20

-

SELECT s_cl_pgm_ls.name "Program_Name", ptcl_num, min(s_cl_subj_st_ls.status_date) "First_Subj_Screened_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_ls, s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Screened' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id and s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id group by s_cl_pgm_ls.name, ptcl_num Protocol approved date cannot be sourced.

M-PRG21

-

SELECT s_cl_pgm_ls.name "Program_Name", ptcl_num, min(s_cl_subj_st_ls.status_date) "First_Subj_Randomized_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_ls, s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Randomized' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id and s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id group by s_cl_pgm_ls.name, ptcl_num Protocol approved date cannot be sourced.

M-PRG22

-

select s_cl_pgm_ls.name "Program_Name", min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date" from s_cl_pgm_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id group by s_cl_pgm_ls.name Last site initiated date cannot be sourced.

M-PRG23

S_CL_PTCL_DT

DB_LOCK_DT Last subject last visit date cannot be sourced. Database Lock date for the protocol can get from: S_CL_PTCL_LS.DB_LOCK_DT

M-PRG24

S_EVT_ACT.APPT_START_DT

-

M-RCF01

-

Not sourced from SC

M-RCF05

-

Not sourced from SC

M-RCF06

-

Not sourced from SC

M-RCF07

-

Not sourced from SC

M-RCF08

-

Not sourced from SC

M-RCF09

-

Not sourced from SC

M-RCF10

-

Not sourced from SC

M-RCF11

-

Not sourced from SC

M-RCF13

-

Not sourced from SC

M-RCF14

-

Not sourced from SC

M-RCF15

-

Not sourced from SC

M-RCF16

-

Not sourced from SC

M-RCF17

-

Not sourced from SC

M-RCF18

-

Not sourced from SC

M-RCF19

-

Not sourced from SC

M-RCF20

-

Not sourced from SC

M-RCF21

-

Not sourced from SC

M-RCF21.1

-

Not sourced from SC

M-RCF22

-

Not sourced from SC

M-RCF23

-

Not sourced from SC

M-RCF24

-

Not sourced from SC

M-RCF25

-

Not sourced from SC

M-RCF26

-

Not sourced from SC

M-RCF29

-

Not sourced from SC

M-RCF29.1

-

Not sourced from SC

M-RCF30

-

Not sourced from SC

M-RCF31

-

Not sourced from SC

M-RCF31.1

-

Not sourced from SC

M-RCF32

-

Not sourced from SC

M-RCF33

-

Not sourced from SC

M-RCF34

-

Not sourced from SC

M-RCF35

-

Not sourced from SC

M-RCF36

-

Not sourced from SC

M-RCF37

-

Not sourced from SC

M-RCF38

-

Not sourced from SC

M-RCF39

-

Not sourced from SC

M-RCF40

-

Not sourced from SC

M-RCF41

-

Not sourced from SC

M-RCF42

-

Not sourced from SC

M-RCF43

-

Not sourced from SC

M-RCF44

-

Not sourced from SC

M-RCF45

-

Not sourced from SC

M-RCF45.1

-

Not sourced from SC

M-RCF46

-

Not sourced from SC

M-RCF47

-

Not sourced from SC

M-RCF48

-

Not sourced from SC

M-RCF49

-

Not sourced from SC

M-RCF49.1

-

Not sourced from SC

M-RCF49.2

-

Not sourced from SC

M-RCF50

-

Not sourced from SC

M-RCF52

-

Not sourced from SC

M-RCF52.1

-

Not sourced from SC

M-RCF55.1

-

Not sourced from SC

M-RCF55.2

-

Not sourced from SC

M-RCF58

-

Not sourced from SC

M-RCF62

-

Not sourced from SC

M-RCF62.1

-

Not sourced from SC

M-RCF62.2

-

Not sourced from SC

M-RCF63

-

Not sourced from SC

M-RCF64

-

Not sourced from SC

M-RCF64.1

-

Not sourced from SC

M-RCF64.2

-

Not sourced from SC

M-RCF64.3

-

Not sourced from SC

M-RCF64.4

-

Not sourced from SC

M-RCF65

-

Not sourced from SC

M-RCF68

-

Not sourced from SC

M-RCF69

-

Not sourced from SC

M-RCF70

-

Not sourced from SC

M-RCF71.1

-

Not sourced from SC

M-RCF72

-

Not sourced from SC

M-RCF73

-

Not sourced from SC

M-RCF74

-

Not sourced from SC

M-RCF74.1

-

Not sourced from SC

M-RCF75

-

Not sourced from SC

M-RCF76

-

Not sourced from SC

M-RCF77

-

Not sourced from SC

M-RCF78

-

Not sourced from SC

M-RCF81

-

Not sourced from SC

M-RCF82

-

Not sourced from SC

M-RCF83

-

Not sourced from SC

M-RCF84

-

Not sourced from SC

M-RCF85

-

Not sourced from SC

M-RCF86

-

Not sourced from SC

M-REG05

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num order by 1

M-REG07

-

Number of initiated sites recruiting one or more subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num Number of sites initiated against each protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num

M-REG09

-

Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and NUM_ENROLLED> 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) Number of sites initiated against each protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and NUM_ENROLLED >= 1 group by ptcl_num

M-REG10

-

select region_cd "Region", ptcl_num, site_num, min(st_initn_cmpl_dt) "Site_Initiated_Date"

from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS

where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id

group by region_cd,ptcl_num, site_num order by 1,2,3

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-REG11

-

select region_cd "Region", ptcl_num, site_num, irb_apprv_dt "IRB_Approval_Date"

from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS

where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id

order by 1,2

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-REG12

-

select region_cd "Region",ptcl_num,site_num, irb_apprv_dt "IRB_Approval_Date", st_initn_cmpl_dt "Site_Initiation_Date" from S_PS_STMPVER_LS, s_cl_ptcl_ls, s_ptcl_site_ls where S_PS_STMPVER_LS.ptcl_site_id = s_ptcl_site_ls.row_id and s_cl_ptcl_ls.row_id = cl_ptcl_id order by 1

M-REG14

-

select count(ptcl_num) from s_cl_ptcl_ls

M-REG15

-

select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, min(st_initn_cmpl_dt) "Site_Initiated_Date", min(status_date) "First_Subj_Enrolled_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_st_ls, s_cl_subj_ls where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id and s_cl_subj_st_ls.status_cd = 'Enrolled' group by s_cl_pgm_ls.name, region_cd, ptcl_num, site_num order by 1,2,3

M-REG16

-

select s_cl_pgm_ls.name "Program_Name", region_cd "Region",ptcl_num, site_num, ST_INITN_CMPL_DT "Site_Initiation_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id Critical Document package Completed Date cannot be sourced

M-REG17

-

select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null and b.cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where region_cd = 'USA'))

M-REG18

-

Site visit completed date in a program can get from: select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, TODO_ACTL_END_DT "Site_Visit_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' order by 1,2,3,4 Visit report approved date cannot be sourced.

M-REG19

-

select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, TODO_ACTL_END_DT "Site_Visit_Completed_Date", appt_end_dt "Visit_Rep_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' order by 1,2,3,4 Visit Report Completed date cannot be sourced.

M-REG20

-

select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, appt_end_dt "Visit_Rep_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' order by 1,2,3,4 Visit Report Approved Date cannot be sourced.

M-SBVT03

S_EVT_ACT

TODO_ACTL_END_DT

M-SBVT04

S_EVT_ACT

CMPLTD_FLG

M-SBVT05

S_EVT_ACT

NAME

M-SBVT06

S_EVT_ACT

APPT_START_DT

M-SBVT07

S_EVT_ACT_LSX

MAX_DUE_DT

M-SBVT08

S_EVT_ACT_LSX

MIN_DUE_DT

M-SBVT09

S_EVT_ACT

TODO_PLAN_START_DT

M-SBVT10

S_CL_CFT_LS

PTCL_DEV_FLG

M-SBVT11

S_CL_CFT_LS

PTCL_VLTN_FLG

M-SBVT12

S_EVT_ACT_LSX

EVT_PRRTY_SEQ

M-SBVT13

S_SBJTMP_VER_LS

NAME

M-SBVT14

S_EVT_ACT

TODO_CD

M-SIV01

-

Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_APRVD_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT

M-SIV02

-

Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_CMPLT_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT

M-SIV03

-

Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_START_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT

M-SIV04

-

Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_CMPLT_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_APRVD_DT

M-SIV05

-

Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_APRVD_DT

M-SIV06

-

Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_CMPLT_DT

M-SIV07

-

-

M-SIV08

-

-

M-SIV10

-

-

M-SRG01

S_CL_PTCL_LS.NUM_PLAN_SITE

-

M-SRG02

S_CL_PTCL_LS.NUM_PLAN_SUBJ

-

M-SRG03

-

select S_CL_pgm_ls.name "Program_Name", ptcl_name, min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) from s_cl_pgm_ls, s_cl_ptcl_ls where S_CL_pgm_ls.row_id = cl_pgm_id order by S_CL_pgm_ls.name, ptcl_name

M-SRG04

-

Get the number of sites planned for a study from: S_CL_PTCL_LS.NUM_PLAN_SITE. Get the number of sites initiated in a study using below query: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.st_initn_cmpl_dt is not null group by ptcl_num

M-SRG05

-

To get LATEST Site Initiated Date, we have to use different table, column: max(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Ex: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, max(ST_INITN_CMPL_DT) "Latest_Site_Initiated_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,S_PTCL_SITE_LS where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_ptcl_ls.row_id = cl_ptcl_id group by s_cl_pgm_ls.name,region_cd,ptcl_num

M-SRG06

-

First Site Initiated: min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Latest site initiated date can get from: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num,max(ST_INITN_CMPL_DT) "Latest_Site_Initiated_Date" from s_cl_pgm_ls,s_cl_ptcl_ls, s_ptcl_site_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_cl_pgm_ls.row_id = cl_pgm_id group by s_cl_pgm_ls.name,region_cd,ptcl_num

M-SRG07

-

select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, min(irb_apprv_dt) "IRB_Approval_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS, s_evt_act where s_evt_act.CL_SUBJ_ID is not null and subtype_cd = 'Visit' and s_evt_act.cl_ptcl_st_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id group by s_cl_pgm_ls.name,region_cd,ptcl_num, site_num order by 1,2,3

M-SRG08

-

select s_cl_pgm_ls.name"Program_Name",region_cd "Region",ptcl_num, min (s_cl_subj_st_ls.status_date) -min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "No_Of_Days" from s_cl_pgm_ls,s_cl_ptcl_ls where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num

M-SRG09

-

select count(*) from s_evt_act where par_evt_id in (select activity_uid from s_evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where region_cd = 'USA'))) and subtype_cd = 'Follow-Up'

M-SRG10

-

Get planned subjects of a site from: S_PTCL_SITE_LS.NUM_PLAN_SUBJ. There is no direct column to get the number of subjects randomized. Use below query to get it: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num,site_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls, s_cl_subj_ls, S_CL_SUBJ_ST_LS where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_cl_subj_ls.PTCL_SITE_ID = s_ptcl_site_ls.row_id and S_CL_SUBJ_ST_LS.par_subj_id = s_cl_subj_ls.row_id and S_CL_SUBJ_ST_LS.status_cd = 'Randomized' group by s_cl_pgm_ls.name,region_cd,ptcl_num,site_num

M-SRG11

S_CL_PTCL_LS.NUM_PLAN_SUBJ S_CL_PTCL_LS.NUM_SUBJ_ENRL

-

M-SRG12

-

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

To get Latest Subject 1st Visit:

From S_CL_SUBJ_LS, we have to find out the latest subject (ROW_ID) using max(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null

M-SRG13

-

select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, min(TODO_ACTL_END_DT) "1st_Subject_1st_Visit_Date", min(irb_apprv_dt) "1st_IRB_Approved_Date" from s_cl_pgm_ls,s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS, s_Evt_act where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and subtype_cd = 'Visit' and cl_ptcl_st_id = s_ptcl_site_ls.row_id group by s_cl_pgm_ls.name,region_cd,ptcl_num

M-SRG14

-

select region_cd "Region",ptcl_num, min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", min(irb_apprv_dt) "1st_IRB_Approved_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id group by region_cd,ptcl_num

M-SRG16

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.st_initn_cmpl_dt is not null group by ptcl_num

M-SRG23

-

select region_cd "Region",ptcl_num,ptcl_site_id, irb_apprv_dt "IRB_Approval_Date"

from S_PS_STMPVER_LS, s_ptcl_site_ls, s_cl_ptcl_ls

where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2,3

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-SRG24

-

select region_cd "Region",ptcl_num,cl_ptcl_st_id, min(st_initn_cmpl_dt) "Site_Initiation_Date", min(irb_apprv_dt) "IRB_Approval_Date" from S_PS_STMPVER_LS, s_evt_act, s_ptcl_site_ls, s_cl_ptcl_ls where s_evt_act.CL_SUBJ_ID is not null and subtype_cd = 'Visit' and s_evt_act.cl_ptcl_st_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id group by region_cd,ptcl_num,cl_ptcl_st_id order by 1

M-SRG25

-

select region_cd "Region",ptcl_num,site_num, st_initn_cmpl_dt "Site_Initiation_Date"

from s_ptcl_site_ls, s_cl_ptcl_ls

where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2,3

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-SRG26

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id group by ptcl_num

M-SRG27

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num

M-SRG28

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num

M-SRG29

-

Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.NUM_PLAN_SUBJ > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)

M-SRG30

-

select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where s_cl_pgm_ls.row_id = cl_pgm_id and cl_ptcl_id = s_cl_ptcl_ls.row_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 and st_initn_cmpl_dt is not null group by s_cl_pgm_ls.name,region_cd,ptcl_num order by 1,2,3

M-SRG31

-

select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 and s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id group by s_cl_pgm_ls.name,region_cd,ptcl_num order by 1 Number of sites initiated against each protocol: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null group by s_cl_pgm_ls.name,region_cd,ptcl_num order by 1,2,3

M-SRG32

-

Number of sites which enrolled atleast 90% of planned subjects in a protocol: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls where s_cl_pgm_ls.row_id = cl_pgm_id and cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.NUM_PLAN_SUBJ > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by s_cl_pgm_ls.name,region_cd,ptcl_num order by 1,2,3 Number of sites initiated against each protocol: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null group by s_cl_pgm_ls.name,region_cd,ptcl_num Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)

M-SRG33

-

Not sourced from SC

M-SRG34

-

Not sourced from SC

M-SST01

S_PTCL_SITE_LS.NUM_PLAN_SUBJ

-

M-SST02

S_PTCL_SITE_LS.NUM_SUBJ_ENRL

-

M-SST02C

S_CL_SUBJ_LS.PR_STATUS_ID

Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD="Enrolled"

M-SST03

S_PTCL_SITE_LS.NUM_SUBJ_ENRL+S_PTCL_SITE_LS.NUM_COMPLTD

-

M-SST04

S_PTCL_SITE_LS.NUM_SUBJ_ENRL

-

M-SST05

S_PTCL_SITE_LS.NUM_COMPLTD

-

M-SST05C

S_CL_SUBJ_LS.PR_STATUS_ID

Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD="Completed"

M-SST06

S_PTCL_SITE_LS.NUM_ERLY_TERM

-

M-SST06C

S_CL_SUBJ_LS.PR_STATUS_ID

Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD="Early Terminated"

M-SST08

-

Not sourced from SC

M-SST09

-

Not sourced from SC

M-SST15.1

(S_PTCL_SITE_LS.NUM_SUBJ_ENRL/ S_PTCL_SITE_LS.NUM_PLAN_SUBJ) * 100

-

M-SST17

-

Not sourced from SC

M-SST18

-

Not sourced from SC

M-SST19

-

Not sourced from SC

M-SST20

-

Not sourced from SC

M-SST21

-

Not sourced from SC

M-SST23

-

Not sourced from SC

M-SST24

-

Not sourced from SC

M-SST24.1

-

Not sourced from SC

M-SST24.2

-

Not sourced from SC

M-SST24.3

-

Not sourced from SC

M-SST27

-

Not sourced from SC

M-SST28

-

Not sourced from SC

M-SST29

-

Not sourced from SC

M-SST30

-

Not sourced from SC

M-SST31

-

Not sourced from SC

M-SST32

S_CL_SUBJ_ST_LS.STATUS_CD

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'

M-SST32C

S_CL_SUBJ_LS.PR_STATUS_ID

Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD='Randomized'

M-SST33

S_CL_SUBJ_LS.STATUS_CD

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Re-Screened'

M-SST33C

S_CL_SUBJ_LS.PR_STATUS_ID

Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD='Re-Screened'

M-SST34

S_CL_SUBJ_ST_LS.STATUS_CD

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screen Failure'

M-SST34C

S_CL_SUBJ_LS.PR_STATUS_ID

Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD='Screen Failure'

M-SST35

S_CL_SUBJ_LS.STATUS_CD

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'

M-SST35C

S_CL_SUBJ_LS.PR_STATUS_ID

Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD='Screened'

M-SST36

S_CL_SUBJ_LS.INTEGRATION_ID

-

M-SST37

S_CL_SUBJ_LS.PTCL_DEV_FLG

-

M-SST38

S_CL_SUBJ_LS.PTCL_VLTN_FLG

-

M-SST39

S_PTCL_SITE_LS.ST_INITN_CMPL_DT

-

M-SST40

S_CL_SUBJ_LS.WTHDWN_DT

-

M-SST41

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Completed'

M-SST42

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'

M-SST43

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'

M-SST44

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'

M-SST45

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Completed'

M-SST46

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'

M-SST47

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'

M-SST48

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'

M-SST49

COUNT (S_PTCL_SITE_LS.ROW_ID)

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'

M-SST50

S_EVT_ACT.DOC_SENT_DT - S_EVT_ACT.DOC_RCVD_DT

-

M-SST51

S_EVT_ACT.DOC_SENT_DT - Current timestamp

Where S_EVT_ACT.DOC_RCVD_DT is null

M-SST52

Current timestamp - M-SST46

-

M-SST54

M-SST02 / # Subjects Enrolled at Study

-

M-SST55

M-SST32 / # Randomized at Study

-

M-SST56

M-SST35 / # Screened at Study

-

M-SST57

M-SST06 / M-SST02

Total for Study-site

M-SST58

M-SST06 / M-SST02

Total for Study

M-SST59

M-SST51 / # Documents

-

M-SST60

Avg (M-SST50)

-

M-SST61

-

-

M-SST62

-

-

M-SST63

-

Current date- latest site visit Completed date

M-SST65

-

Count(W_RXI_SITE_VISIT_F.ROW_WID)

M-SST66

-

Count (S_CL_SUBJ_ST_LS.ROW_ID) from S_CL_SUBJ_ST_LS, S_EVT_ACT SiteVisit, S_CL_SUBJ_LS where S_CL_SUBJ_ST_LS.STATUS_CD = 'Enrolled' and S_CL_SUBJ_ST_LS.STATUS_DATE > (MAX (SiteVisit.TODO_ACTL_END_DT) and SiteVisit.SUBTYPE_CD = "Site Visit" and SiteVisit.CL_PTCL_ST_ID = S_CL_SUBJ_LS.PTCL_SITE_ID and S_CL_SUBJ_ST_LS.PAR_SUBJ_ID = S_CL_SUBJ_LS.ROW_ID

M-SST67

-

Count (S_CL_SUBJ_ST_LS.ROW_ID) from S_CL_SUBJ_ST_LS, S_EVT_ACT SiteVisit, S_CL_SUBJ_LS where S_CL_SUBJ_ST_LS.STATUS_CD = 'Randomized' and S_CL_SUBJ_ST_LS.STATUS_DATE > (MAX (SiteVisit.TODO_ACTL_END_DT) and SiteVisit.SUBTYPE_CD = "Site Visit" and SiteVisit.CL_PTCL_ST_ID = S_CL_SUBJ_LS.PTCL_SITE_ID and S_CL_SUBJ_ST_LS.PAR_SUBJ_ID = S_CL_SUBJ_LS.ROW_ID

M-SST68

-

Count (S_CL_SUBJ_ST_LS.ROW_ID) from S_CL_SUBJ_ST_LS, S_EVT_ACT SiteVisit, S_CL_SUBJ_LS where S_CL_SUBJ_ST_LS.STATUS_CD = 'Screened' and S_CL_SUBJ_ST_LS.STATUS_DATE > (MAX (SiteVisit.TODO_ACTL_END_DT) and SiteVisit.SUBTYPE_CD = "Site Visit" and SiteVisit.CL_PTCL_ST_ID = S_CL_SUBJ_LS.PTCL_SITE_ID and S_CL_SUBJ_ST_LS.PAR_SUBJ_ID = S_CL_SUBJ_LS.ROW_ID

M-SST69

-

When Visit report completed date is NOT null

M-SST70

-

When Visit report completed date is NOT null and visit report approval date is also null then count record

M-SST71

-

when site visit complete date IS NOT NULL and visit report complete date both are IS null then count

M-SST72

-

M-SST32 # Subjects Randomized / M-SST01 # Subjects Planned for Study-Site

M-SST73

-

Min(when site visit start date> AD10-41 Site initiated date, return site visit start date)

M-SST74

-

Max (when site visit complete date <= current date, site visit complete date)

M-SST75

-

Max(when site visit start date <= current date, return site visit start date)

M-SST76

-

select cl_ptcl_st_id, TODO_PLAN_START_DT "Site_Visit_Start_Date" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where site_num = 'US-001' and cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374')) order by cl_ptcl_st_id, TODO_PLAN_START_DT

M-SST77

-

select cl_ptcl_st_id, count(*) "No_Of_Follow_Up_Items" from s_evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Follow-Up' group by cl_ptcl_st_id

M-SST78

-

Min(when site visit start date> current date , return site visit start date)

M-SST79

S_EVT_ACT.TODO_ACTL_END_DT

select min(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, MAX(STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled" And S_CL_SUBJ_LS.PTCL_SITE_ID = row_id of the site you are calculating this for)

M-SST80

s_evt_act.TODO_ACTL_END_DT

-

M-SST81

-

select max (S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, MAX (STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled" And S_CL_SUBJ_LS.PTCL_SITE_ID = row_id of the site you are calculating this for)

M-SST82

-

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

and site initiated date can get from: S_PTCL_SITE_LS.ST_INITN_CMPL_DT

M-SST83

-

select site_num, irb_apprv_dt "IRB_Approved_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS

where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id order by 1

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-SST84

-

SELECT site_num, irb_apprv_dt-ST_INITN_CMPL_DT "No_Of_Days" from s_ptcl_site_ls, S_PS_STMPVER_LS where ptcl_site_id = s_ptcl_site_ls.row_id

M-SST85

-

site initiated date can get from: S_PTCL_SITE_LS.ST_INITN_CMPL_DT Critical document package completed date cannot be sourced.

M-SST86

S_CL_SUBJ_ST_LS

select site_num,to_char(enrl_dt, 'Month'), count(*) from S_cl_subj_ls,s_ptcl_site_ls,s_cl_ptcl_ls where enrl_dt is not null and ptcl_site_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.SITE_TERM_DT is not null and enrl_dt >= st_initn_cmpl_dt group by site_num,to_char(enrl_dt, 'Month') order by 2

M-SST87

S_CL_SUBJ_ST_LS

The number of subjects screened against each site can get from: select site_num, count(*) from s_cl_subj_ls, s_ptcl_site_ls, S_CL_SUBJ_ST_LS where ptcl_site_id = s_ptcl_site_ls.row_id and s_cl_subj_ls.row_id = S_CL_SUBJ_ST_LS.PAR_SUBJ_ID and s_cl_subj_ls.screen_dt is not null and S_CL_SUBJ_ST_LS.status_cd = 'Screened' group by site_num order by 1 The number of subjects screen failed against each site : select site_num, count(*) from s_cl_subj_ls, s_ptcl_site_ls, S_CL_SUBJ_ST_LS where ptcl_site_id = s_ptcl_site_ls.row_id and s_cl_subj_ls.row_id = S_CL_SUBJ_ST_LS.PAR_SUBJ_ID and s_cl_subj_ls.screen_dt is not null and S_CL_SUBJ_ST_LS.status_cd = 'Screen Failure' group by site_num order by 1

M-SST88

S_CL_PTCL_LS S_CL_SUBJ_LS

site_num enrl_dt num_subj_enrl num_plan_subj

M-SST89

-

Not sourced from SC

M-SST90

-

Not sourced from SC

M-SST91

-

Not sourced from SC

M-SST92

-

Not sourced from SC

M-SST93

S_CL_PTCL_LS

select site_num, fst_subj_enrl_dt-ST_INITN_CMPL_DT "No_Of_Days" from s_ptcl_site_ls

M-SST94

S_CL_PTCL_LS.NUM_PLAN_SUBJ S_CL_PTCL_LS.NUM_SUBJ_ENRL

-

M-SST95

-

Not sourced from SC

M-SST96

S_EVT_ACT

select min(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, min (STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled" And S_CL_SUBJ_LS.PTCL_SITE_ID = row_id of the site you are calculating this for)

M-SST97

-

See Flag section

M-SST98

-

See Flag section

M-SST99

-

See Flag section

M-SST100

-

See Flag section

M-SST101

-

See Flag section

M-SST102

-

See Flag section

M-SST103

-

See Flag section

M-SST104

-

See Flag section

M-SST105

-

See Flag section

M-SST106

-

See Flag section

M-SST107

-

See Flag section

M-STD02

S_CL_PTCL_LS.NUM_PLAN_SUBJ

-

M-STD06

S_CL_PTCL_LS.DB_LOCK_DT

-

M-STD07

COUNT (S_PTCL_SITE_LS.ROW_ID)

-

M-STD08

S_PTCL_SITE_LS.NUM_SUBJ_ENRL

-

M-STD09

S_EVT_ACT.TODO_PLAN_START_DT S_EVT_ACT.

Where TODO_ACTL_END_DT is not null

M-STD10

-

M-SST32 # Subjects Randomized / M-STD02 # Subjects Planned for Study

M-STD11

-

Min(AD10-41 Study site Initiated Date)

M-STD12

-

Max(AD10-41 Study site Initiated Date)

M-STD13

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.st_initn_cmpl_dt is not null group by ptcl_num

M-STD14

-

Not sourced from SC

M-STD15

-

From S_CL_SUBJ_LS, we have to find out the latest subject (ROW_ID) using max(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get max(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null

M-STD16

-

Not sourced from SC

M-STD17

-

Not sourced from SC

M-STD18

-

Not sourced from SC

M-STD20

-

select ptcl_num, site_num "Site_Number", ST_INITN_CMPL_DT "Site_Initiated_Date"

from s_ptcl_site_ls, s_cl_ptcl_ls

where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-STD21

-

select ptcl_num, irb_apprv_dt "IRB_Approval_Date"

from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS

where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-STD22

-

select ptcl_num, site_num, irb_apprv_dt "IRB_Approval_Date", st_initn_cmpl_dt "Site_Initiation_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2

M-STD23

S_CL_PTCL_LS.NUM_PLAN_SUBJ S_CL_PTCL_LS.NUM_SUBJ_ENRL

-

M-STD24

-

select ptcl_num, min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", min (s_cl_subj_st_ls.status_date) "1st_Subj_Enroll_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_subj_st_ls.status_cd = 'Enrolled' and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num group by ptcl_num

M-STD25

-

select ptcl_num, min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", max(st_initn_cmpl_dt) "Latest_Site_Initiated_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id group by ptcl_num

M-STD26

-

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

Latest subject 1st visit can get from:

From S_CL_SUBJ_LS, we have to find out the latest subject (ROW_ID) using max(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_S

ITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null

M-STD27

-

select ptcl_num, irb_apprv_dt "1st_IRB_Approved_Date"

from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS

where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id

order by 1

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and

M-STD28

-

Number of planned sites for a protocol can get from: S_CL_PTCL_LS.NUM_PLAN_SITE Number of sites initiated in a protocol can get from: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null group by ptcl_num

M-STD29

-

Number of sites which are initiated recruiting 0 subjects: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num

M-STD30

-

Number of sites recruiting one or more subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num Number of sites initiated against each protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num

M-STD31

-

Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and NUM_ENROLLED > 0 and NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Number of sites initiated against each protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and NUM_ENROLLED >= 1 group by ptcl_num Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)

M-STD32

-

select site_num,min(irb_apprv_dt) from S_PS_STMPVER_LS, s_ptcl_site_ls where ptcl_site_id = s_ptcl_site_ls.row_id group by site_num order by 1

M-STD40

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num order by 1

M-STD42

-

select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.ST_INITN_CMPL_DT is not null and s_ptcl_site_ls.NUM_PLAN_SUBJ > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)

M-STD43

-

The number of subjects enrolled per month in a protocol which does not have a database lock date: select ptcl_num, to_char(enrl_dt, 'Month'), count(*) from S_cl_subj_ls,s_ptcl_site_ls,s_cl_ptcl_ls where enrl_dt is not null and ptcl_site_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.cl_ptcl_id = s_cl_ptcl_ls.row_id and s_cl_ptcl_ls.db_lock_dt is null group by ptcl_num,to_char(enrl_dt, 'Month') order by 2 The number of subjects enrolled per month in a protocol which have a database lock date: select ptcl_num, to_char(enrl_dt, 'Month'), count(*) from S_cl_subj_ls,s_ptcl_site_ls,s_cl_ptcl_ls where enrl_dt is not null and ptcl_site_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.cl_ptcl_id = s_cl_ptcl_ls.row_id and s_cl_ptcl_ls.db_lock_dt is not null group by ptcl_num,to_char(enrl_dt, 'Month') order by 2

M-STD44

-

Not sourced from SC

M-STD45

-

Not sourced from SC

M-STD46

-

Not sourced from SC

M-STD47

-

Not sourced from SC

M-STD48

-

select count(ptcl_num) from s_cl_ptcl_ls

M-STD49

-

select cl_ptcl_st_id, TODO_PLAN_START_DT "Site_Visit_Start_Date" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374')) order by cl_ptcl_st_id, TODO_PLAN_START_DT

M-STD50

-

select count(*) from s_evt_act where par_evt_id in (select activity_uid from s_evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374'))) and subtype_cd = 'Follow-Up'

M-STD51

-

Not sourced from SC

M-STD52

-

select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null and b.cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374'))

M-STD53

-

select ptcl_num,site_num,TODO_ACTL_END_DT "Site_Visit_Completed_Dt" from s_cl_ptcl_ls, s_ptcl_site_ls, s_evt_act where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and TODO_ACTL_END_DT is not null and subtype_Cd = 'Site Visit' and s_evt_act.cl_ptcl_st_id = s_ptcl_site_ls.row_id order by 1,2 Visit Report Approved Date cannot be sourced.

M-STD54

-

select ptcl_num,site_num,TODO_ACTL_END_DT "Site_Visit_Completed_Dt", appt_end_dt "Visit_Rep_Completed_Dt" from s_cl_ptcl_ls, s_ptcl_site_ls, s_evt_act where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and TODO_ACTL_END_DT is not null and subtype_Cd = 'Site Visit' and s_evt_act.cl_ptcl_st_id = s_ptcl_site_ls.row_id order by 1,2

M-STD55

-

Not sourced from SC

M-STD56

-

select ptcl_num, min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", min(irb_apprv_dt) "1st_IRB_Approved_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id group by ptcl_num

M-STD57

-

Not sourced from SC

M-STD58

-

Not sourced from SC

M-STD59

-

Not sourced from SC

M-STD60

-

select ptcl_num, site_num "Site_Number", min(ST_INITN_CMPL_DT) "Site_Initiated_Date",min (s_cl_subj_st_ls.status_date)"1st_Subj_Enroll_Dt" from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num group by ptcl_num,site_num order by 1,2 Get FST_SBJ_ENRL_DT by: select min (s_cl_subj_st_ls.status_date) where s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num

M-STD61

-

SELECT s_cl_ptcl_ls.ptcl_num, min (s_cl_subj_st_ls.status_date) "1st_Subj_Enroll_Date", max(s_cl_subj_st_ls.status_date) "Latest_Subj_Enroll_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_ls, s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num

M-STD62

-

Not sourced from SC

M-STD63

S_EVT_ACT.APPT_END_DT

-

M-STD64

-

Not sourced from SC

M-STD65

-

Not sourced from SC

M-STD66

-

Not sourced from SC

M-STD67

-

Not sourced from SC

M-STD68

-

Not sourced from SC

M-STD69

-

Not sourced from SC

M-STD70

-

Not sourced from SC

M-STD71

-

See Flag section

M-STD72

-

See Flag section

M-STD73

-

See Flag section

M-STD74

-

See Flag section

M-STD75

-

See Flag section

M-STD76

-

See Flag section

M-STD77

-

See Flag section

M-STD78

-

See Flag section

M-STD79

-

See Flag section

M-STD80

-

See Flag section

M-STD81

-

See Flag section

M-STD82

-

See Flag section

M-STD83

-

Select Count (S_CL_SUBJ_ST_LS.PAR_SUBJ_ID) From S_CL_SUBJ_ST_LS, S_PTCL_SITE_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Screen Failure" And S_CL_SUBJ_LS.PTCL_SITE_ID = S_PTCL_SITE_LS.ROW_ID And S_PTCL_SITE_LS.CL_PTCL_ID = row_id of the study you are calculating this for) / Select Count (S_CL_SUBJ_ST_LS.PAR_SUBJ_ID) From S_CL_SUBJ_ST_LS, S_PTCL_SITE_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Screened" And S_CL_SUBJ_LS.PTCL_SITE_ID = S_PTCL_SITE_LS.ROW_ID And S_PTCL_SITE_LS.CL_PTCL_ID = row_id of the study you are calculating this for)

M-STD84

-

select min(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, min (STATUS_DATE) From S_CL_SUBJ_ST_LS, S_PTCL_SITE_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled" And S_CL_SUBJ_LS.PTCL_SITE_ID = S_PTCL_SITE_LS.ROW_ID And S_PTCL_SITE_LS.CL_PTCL_ID = row_id of the study you are calculating this for)

M-STD85

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'

M-STD86

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'

M-STD87

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'

M-STD88

S_EVT_ACT.TODO_ACTL_END_DT

select min (S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, MAX (STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled")

M-STD89

-

SELECT max (s_cl_subj_st_ls.status_date) from s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Enrolled'

M-STD90

S_EVT_ACT.TODO_ACTL_END_DT

select max(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V'

M-STD91

-

SELECT max (s_cl_subj_st_ls.status_date) from s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Randomized'

M-STR01

-

count (S_CL_SUBJ_ST_LS.STATUS_CD = "Early Terminated")/ count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)

M-STR02

-

SELECT region_cd "Region",s_cl_ptcl_ls.ptcl_num, min (s_cl_subj_st_ls.status_date) "1st_Sub_Enroll_Date",max(s_cl_subj_st_ls.status_date) "Latest_Subj_Enroll_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_ls, s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by region_cd,s_cl_ptcl_ls.ptcl_num

M-STR03

S_CL_PTCL_LS S_CL_SUBJ_LS

site_num enrl_dt num_subj_enrl num_plan_subj

M-STR04

-

Not sourced from SC

M-STR05

-

Not sourced from SC

M-STR06

-

Not sourced from SC

M-STR07

S_CL_PTCL_LS. S_CL_PTCL_LS.

NUM_SCRN_FAIL NUM_SUBJ_SCRN

M-STR08

-

select region_cd "Region", ptcl_num, site_num, min(st_initn_cmpl_dt) "Site_Initiated_Date", min(status_date) "First_Subj_Enrolled_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_st_ls, s_cl_subj_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id and s_cl_subj_st_ls.status_cd = 'Enrolled' group by region_cd, ptcl_num, site_num order by 1,2,3

M-STR09

-

Not sourced from SC

M-STR10

-

Not sourced from SC

M-STR11

S_EVT_ACT.TODO_PLAN_START_DT

select cl_ptcl_st_id, TODO_PLAN_START_DT "Site_Visit_Start_Date" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where region_cd = 'USA')) order by cl_ptcl_st_id, TODO_PLAN_START_DT

M-STR12

-

Not sourced from SC

M-STR13

-

Not sourced from SC

M-STR14

-

Not sourced from SC

M-STR15

-

Not sourced from SC

M-STR16

S_EVT_ACT

TODO_PLAN_START_DT TODO_ACTL_END_DT select region_cd "Region",ptcl_num,cl_ptcl_st_id, TODO_PLAN_START_DT "site_Visit_Start_Date", TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt" from s_cl_ptcl_ls,s_ptcl_site_ls,s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_Evt_act.cl_ptcl_st_id

M-STR17

-

(S_PTCL_SITE_LS.NUM_SUBJ_ENRL/ S_PTCL_SITE_LS.NUM_PLAN_SUBJ) * 100

M-STR18

-

Not sourced from SC

M-STR19

-

Not sourced from SC

M-STR20

-

Not sourced from SC

M-STR21

-

See Flag section

M-STR22

-

See Flag section

M-STR23

-

See Flag section

M-STR24

-

See Flag section

M-STR25

-

See Flag section

M-STR26

-

See Flag section

M-STR27

-

See Flag section

M-STR28

-

See Flag section

M-STR29

-

See Flag section

M-STR30

S_CL_PTCL_LS

NUM_PLAN_SUBJ NUM_PLAN_SITE NUM_SUBJ_ENRL

M-STR31

S_EVT_ACT.TODO_ACTL_END_DT

select min(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V'

M-STR32

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'

M-STR33

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'

M-STR34

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'

M-STR35

S_EVT_ACT.TODO_ACTL_END_DT

select min (S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, MAX (STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = ""Enrolled"")

M-STR36

-

SELECT max (s_cl_subj_st_ls.status_date) from s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Enrolled'

M-STR37

S_EVT_ACT.TODO_ACTL_END_DT

select max(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V'

M-STR38

-

SELECT max (s_cl_subj_st_ls.status_date) from s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Randomized'

M-TA01

S_CL_PTCL_LS

NUM_PLAN_SUBJ NUM_PLAN_SITE NUM_SUBJ_ENRL SELECT S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME, count(*) "Num_Of_Sites_Initiated" FROM S_CL_PGM_LS, S_PTCL_SITE_LS, S_CL_PTCL_LS WHERE S_CL_PGM_LS.ROW_ID = S_CL_PTCL_LS.CL_PGM_ID AND S_CL_PTCL_LS.ROW_ID = S_PTCL_SITE_LS.CL_PTCL_ID AND ST_INITN_CMPL_DT IS NOT NULL GROUP BY S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME order by S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME

M-TA03

S_CL_PTCL_LS

To get LATEST Site Initiated Date, we have to use different table, column: max(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Ex: select max(ST_INITN_CMPL_DT) from S_PTCL_SITE_LS where CL_PTCL_ID = '1-4LOA' min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT)

M-TA05

S_PS_STMPVER_LS S_CL_PTCL_LS

select site_num, irb_apprv_dt "IRB_Approval_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls

where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_idorder by 1

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-TA06

S_PS_STMPVER_LS S_CL_PTCL_LS

select site_num, irb_apprv_dt "IRB_Approval_Date", st_initn_cmpl_dt "Site_Initiation_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls where S_PS_STMPVER_LS.ptcl_site_id = s_ptcl_site_ls.row_id order by 1

M-TA07

-

Not sourced from SC

M-TA08

-

Not sourced from SC

M-TA09

S_CL_SUBJ_LS

select site_num, st_initn_cmpl_dt "Site_Initiation_Date" from s_ptcl_site_ls order by 1

1st Subject 1st Visit can get from:

From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.

S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)

Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS

Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'

M-TA10

S_CL_PGM_LS S_CL_PTCL_LS

NAME select S_CL_PGM_LS.name, count(*) from S_CL_PGM_LS, S_CL_PTCL_LS where S_CL_PTCL_LS.CL_PGM_ID = S_CL_PGM_LS.ROW_ID group by S_CL_PGM_LS.name This query should give the number of protocols against each program/Therapeutic Area.

M-TA11

S_EVT_ACT

select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null and b.cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where cl_pgm_id in (select row_id from s_cl_pgm_ls where name = 'Anemia')))

M-TA12

S_EVT_ACT

TODO_ACTL_END_DT WHERE SUBTYPE_CD = 'Site Visit'

M-TA13

S_EVT_ACT

TODO_ACTL_END_DT WHERE SUBTYPE_CD = 'Site Visit'

M-TA14

S_EVT_ACT

TODO_ACTL_END_DT TODO_PLAN_START_DT WHERE SUBTYPE_CD = 'Site Visit'

M-TA15

-

Not sourced from SC

M-TA16

-

Not sourced from SC

M-TA20

S_PTCL_SITE_LS

SITE_NUM NUM_SUBJ_ENRL select s_cl_pgm_ls.name "Program_Name",Ptcl_num,count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls WHERE s_ptcl_site_ls.st_initn_cmpl_dt is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by s_cl_pgm_ls.name,Ptcl_num order by 1,2

M-TA21

S_PTCL_SITE_LS

SITE_NUM NUM_SUBJ_ENRL select count(*) from s_ptcl_site_ls WHERE count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) > 1 To get number of sites initiated: SELECT S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME, count(*) "Num_Of_Sites_Initiated" FROM S_CL_PGM_LS, S_PTCL_SITE_LS, S_CL_PTCL_LS WHERE S_CL_PGM_LS.ROW_ID = S_CL_PTCL_LS.CL_PGM_ID AND S_CL_PTCL_LS.ROW_ID = S_PTCL_SITE_LS.CL_PTCL_ID AND ST_INITN_CMPL_DT IS NOT NULL GROUP BY S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME order by S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME

M-TA22

-

Not sourced from SC

M-TA23

-

Not sourced from SC

M-TA24

-

Not sourced from SC

M-TA25

-

Not sourced from SC

M-TA26

-

Not sourced from SC

M-TA27

S_EVT_ACT

select cl_ptcl_st_id, TODO_PLAN_START_DT "Site_Visit_Start_Date" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where site_num = 'US-001' and cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374')) order by cl_ptcl_st_id, TODO_PLAN_START_DT

TA-DISC01

-

Not sourced from SC

TA-DISC02

-

Not sourced from SC

TA-DISC03

-

Not sourced from SC

TA-DISC04

-

Not sourced from SC

TA-DISC05

-

Not sourced from SC

TA-DISC06

-

Not sourced from SC

TA-DISC07

-

Not sourced from SC

TA-DISC08

-

Not sourced from SC

TA-DISC09

-

Not sourced from SC

TA-DISC10

-

Not sourced from SC

TA-DISC11

-

Not sourced from SC

TA-DISC12

-

Not sourced from SC

TA-DISC13

-

Not sourced from SC

TA-DISC14

-

Not sourced from SC

TA-DISC15

-

Not sourced from SC

TA-DISC16

-

Not sourced from SC

TA-DISC17

-

Not sourced from SC

TA-DISC19

-

Not sourced from SC

TA-DISC20

-

Not sourced from SC

TA-DISC21

-

Not sourced from SC

TA-DISC22

-

Not sourced from SC

TA-DISC22.1

-

Not sourced from SC

TA-DISC23

-

Not sourced from SC

TA-DISC24

-

Not sourced from SC

TA-DISC25

-

Not sourced from SC

TA-DISC26

-

Not sourced from SC

TA-DISC26.1

-

Not sourced from SC

TA-DISC30

-

Not sourced from SC

TA-DISC31

-

Not sourced from SC

TA-DISC32

-

Not sourced from SC

TA-DISC33

-

Not sourced from SC

TA-DOC01

S_EVT_ACT.SUBTYPE_CD

-

TA-DOC02

S_EVT_ACT.COMMENTS_LONG

-

TA-DOC03

S_EVT_ACT.NAME

-

TA-DOC04

S_EVT_ACT.TODO_CD

-

TA-DOC05

S_EVT_ACT.DOC_EXPCTD_DT

-

TA-DOC06

S_EVT_ACT.DOC_RCVD_DT

-

TA-DOC07

S_EVT_ACT.DOC_SENT_DT

-

TA-DOC08

S_EVT_ACT.APPT_END_DT

-

TA-DOC09

-

""Study Level Document"" WHEN s_evt_act.CL_PTCL_ID is not null AND S_CL_PTCL_LS.REGION_CD is null Join using where s_evt_act.CL_PTCL_ID = S_CL_PTCL_LS.row_id ""Region Level Document"" WHEN s_evt_act.CL_PTCL_ID is not null AND S_CL_PTCL_LS.REGION_CD is NOT null Join using where s_evt_act.CL_PTCL_ID = S_CL_PTCL_LS.row_id ""Site Level Document"" WHEN s_evt_act.TARGET_OU_ID is not null ""Contact Level Document"" WHEN s_evt_act.TARGET_PER_ID is not null ""Study-Site Level Document"" WHEN s_evt_act.CL_PTCL_ST_ID is not null

TA-FUI01

S_EVT_ACT.COMMENTS

-

TA-FUI02

S_EVT_ACT.TODO_ACTL_END_DT

-

TA-FUI03

S_EVT_ACT.CREATED

-

TA-FUI04

S_EVT_ACT.NAME

-

TA-FUI05

S_EVT_ACT.APPT_START_DT

-

TA-FUI06

S_EVT_ACT.EVT_STAT_CD

-

TA-FUI07

S_EVT_ACT.TODO_CD

-

TA-FUI08

S_EVT_ACT.ROW_ID

-

TA-RCRF01

-

Not sourced from SC

TA-RCRF02

-

Not sourced from SC

TA-RCRF03

-

Not sourced from SC

TA-RCRF04

-

Not sourced from SC

TA-RCRF05

-

Not sourced from SC

TA-RCRF06

-

Not sourced from SC

TA-RCRF07

-

Not sourced from SC

TA-RCRF08

-

Not sourced from SC

TA-RCRF09

-

Not sourced from SC

TA-RCRF10

-

Not sourced from SC

TA-RCRF11

-

Not sourced from SC

TA-RCRF12

-

Not sourced from SC

TA-RCRF13

-

Not sourced from SC

TA-RCRF14

-

Not sourced from SC

TA-RCRF15

-

Not sourced from SC

TA-RCRF16

-

Not sourced from SC

TA-RCRF17

-

Not sourced from SC

TA-RCRF19

-

Not sourced from SC

TA-RCRF20

-

Not sourced from SC

TA-RCRF22

-

Not sourced from SC

TA-RCRF23

-

Not sourced from SC

TA-RCRF24

-

Not sourced from SC

TA-RCRF25

-

Not sourced from SC

TA-RCRF26

-

Not sourced from SC

TA-RCRF28

-

Not sourced from SC

TA-RCRF29

-

Not sourced from SC

TA-RCRF30

-

Not sourced from SC

TA-RCRF31

-

Not sourced from SC

TA-RCRF32

-

Not sourced from SC

TA-RCRF33

-

Not sourced from SC

TA-RCRF34

-

Not sourced from SC

TA-RCRF35

-

Not sourced from SC

TA-SITE01

S_PS_STMPVER_LS.IRB_APPRV_DT

-

TA-SIV01

S_EVT_ACT.COMMENTS_LONG

-

TA-SIV02

S_EVT_ACT.TODO_ACTL_END_DT

-

TA-SIV03

S_EVT_ACT.NAME

-

TA-SIV04

-

Not sourced from SC

TA-SIV05

S_EVT_ACT.APPT_END_DT

-

TA-SIV06

S_EVT_ACT.SRA_STAT_CD

-

TA-SIV07

S_EVT_ACT.APPT_START_DT

-

TA-SIV08

S_EVT_ACT.EVT_STAT_CD

-

TA-SIV09

S_EVT_ACT.TODO_CD

-

TA-SIV10

S_EVT_ACT.S_TMPL_PLANITEM.NAME

S_EVT_ACT.TEMPLATE_ID = S_TMPL_PLANITEM.ROWID

TA-SIV11

S_ECT_ACT.ROW_ID

-

TA-SUBJ01

S_CL_SUBJ_ST_LS.STATUS_CD

-

TA-SUBJ02

S_CL_SJ_CSNT_LS.INFO_CONSNT_DT

S_CL_SJ_CSNT_LS.CL_SUBJ_ID = S_CL_SUBJ_LS.ROW_ID S_CL_SJ_CSNT_LS.SUBJ_TMPL_VER_ID = S_SBJTMP_VER_LS.ROW_ID

TA-SUBJ03

S_CL_SUBJ_ST_LS.COMMENTS

-

TA-SUBJ04

S_EVT_ACT

TODO_ACTL_END_DT select min(TODO_ACTL_END_DT) from S_EVT_ACT where subtype_cd = 'Visit'

TA-SUBJ05

S_EVT_ACT

TODO_ACTL_END_DT select cl_subj_id,max(TODO_ACTL_END_DT) "Subj_Visit_Cmpl_Dt" from S_EVT_ACT where subtype_cd = 'Visit' and cl_subj_id is not null and TODO_ACTL_END_DT is not null group by cl_subj_id

TA-SUBJ06

S_EVT_ACT

select cl_subj_id, count(*) from s_evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Visit' group by cl_subj_id

TA-SUBJ07

S_EVT_ACT

There is no direct column to get this measure.

select cl_subj_id, count(*) from s_evt_act where Template_FLG = 'V' and

TODO_PLAN_START_DT is not null and TODO_PLAN_START_DT < ETL_RUN_DATE and TODO_ACTL_END_DT is null

group by cl_subj_id

TA-SUBJ08

S_EVT_ACT

There is no direct column to get this measure.

select cl_subj_id, count(*) from s_evt_act where TODO_PLAN_START_DT

> sysdate and subtype_cd = 'Visit' group by cl_subj_id

TA-SUBJ09

-

Not sourced from SC

TD01-01

S_CL_PTCL_LS.PTCL_NUM

-

TD01-02

S_CL_SUBJ_LS.SUBJ_NUM

-

TD01-03

-

Not sourced from SC

TD01-04

-

Not sourced from SC

TD01-05

S_CL_SUBJ_ST_LS.STATUS_CD

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Early Terminated'

TD01-06

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'

TD01-07

-

Not sourced from SC

TD01-08

S_CL_SUBJ_LS.SUBJ_INITL

-

TD01-09

S_CL_SUBJ_LS.BIRTH_DT

-

TD01-10

-

Not sourced from SC

TD01-11

S_CL_SUBJ_ST_LS.STATUS_CD

-

TD01-12

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Early Terminated'

TD01-16

-

Not sourced from SC

TD01-17

S_CL_SUBJ_ST_LS.STATUS_DATE

S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'

TD01-18

S_CL_SUBJ_LS.ELGBL_FLG

-

TD01-19

S_CL_SUBJ_LS.COMMENTS

-

TD01-20

S_CL_SUBJ_LS.ENRL_NUM

-

TD01-21

S_CL_SUBJ_LS.RDMZATN_NUM

-

TD01-22

S_CL_SUBJ_LS.PTCL_VLTN_FLG

-

TD01-23

S_CL_SUBJ_LS.EXCLD_RSN_CD

-

TD01-24

S_CL_SUBJ_LS.SUBJ_NUM+BIRTH_DT

-

TD01-25

S_CL_SUBJ_LS.PTCL_DEV_FLG

-

TD01-26

S_CL_SUBJ_LS.WTHDWN_RSN_CD

-

TD01-27

.CURRENT_DATE - BIRTH_DT

-

TD01-28

S_CL_SUBJ_ST_LS.STATUS_DATE

-

TD01-29

-

Not sourced from SC

TD01-30

S_CL_SUBJ_LS.ROW_ID

-

AD09-75

S_CL_PTCL_LS.OBJECTIVE_DESC

-

AD09-76

S_ASSESS. ASSESS_TMPL_NAME

-

AD09-77

S_ASSESS. LAST_UPD

-

AD09-78

S_ASSESS. NAME

-

AD09-79

S_ASSESS.DESC_TEXT

-

AD09-81

-

Not sourced from SC

AD09-82

-

Not sourced from SC

AD09-83

-

Not sourced from SC

AD09-84

-

Not sourced from SC

AD09-85

-

Not sourced from SC

AD09-86

-

Not sourced from SC

AD09-87

-

Not sourced from SC

AD09-88

-

Not sourced from SC

AD10-78

S_PTCL_SITE_LS. MAX_ENROLLMENT

-

AD10-79

S_ASSESS. ASSESS_TMPL_NAME

-

AD10-80

S_ASSESS. LAST_UPD

-

AD10-81

S_ASSESS. NAME

-

AD10-82

S_PTCL_SITE_LS. SDV_TYPE_CD

-

AD10-82

S_PTCL_SITE_LS. SDV_TYPE_CD

-

AD16-17

S_ASSESS. ASSESS_TMPL_NAME

-

AD16-18

S_ASSESS. LAST_UPD

-

AD16-19

S_ASSESS. NAME

-

AD16-20

S_ASSESS.DESC_TEXT

-

AD16-21

S_ASSESS. SCORE

-

AD17-48

S_ASSESS. ASSESS_TMPL_NAME

-

AD17-49

S_ASSESS. LAST_UPD

-

AD17-50

S_ASSESS. NAME

-

AD17-51

S_ASSESS.DESC_TEXT

-

AD18-13

-

Not sourced from SC

AD18-14

-

Not sourced from SC

AD18-15

-

Not sourced from SC

AD18-16

-

Not sourced from SC

AD18-17

-

Not sourced from SC

AD18-18

-

Not sourced from SC

AD18-19

-

Not sourced from SC

AD18-20

-

Not sourced from SC

AD18-21

-

Not sourced from SC

AD18-22

-

Not sourced from SC

AD23-01

-

Not sourced from SC

AD23-02

-

Not sourced from SC

AD23-03

S_ASSESS_VAL . ATTRIB_NAME

-

Note: This column is a concatenation of Category + : + Question. For this measure source only the substring before the first ": " If field does not have a ":" or begins with a ":", then use the category "No Category".

AD23-04

-

Not sourced from SC

AD23-05

-

Not sourced from SC

AD23-07

-

Not sourced from SC

M-PRR01

-

Not sourced from SC

M-PRR02

-

Not sourced from SC

M-PRR03

-

Not sourced from SC

M-PRR04

S_ASSESS_VAL .SCORE

-

M-PRR05

S_ASSESS_VAL .COMMENTS

-

M-PRR06

S_ASSESS_VAL .SEQUENCE_NUM

-

M-PRR07

-

Not sourced from SC

M-PRR08

S_ASSESS_VAL . ATTRIB_NAME

-

M-PRR09

-

Not sourced from SC

M-PRR10

Impact (M-PRR04)

-

M-PRR11

S_ASSESS_VAL . WEIGHT

-

M-PRR12

Avg of child question scores

-

M-PTL01

S_PTCL_VER_LS. AMND_VERSION

-

M-PTL02

S_PTCL_VER_LS. VER_CREATED_DT

-

M-PTL03

S_PTCL_VER_LS. ORIG_VER_FLG

-

M-PTL04

-

Not sourced from SC

M-PTL05

-

Not sourced from SC

M-PTL06

S_PTCL_VER_LS. COMMENTS

-

M-SDR01

-

Not sourced from SC

M-SDR02

-

Not sourced from SC

M-SDR03

-

Not sourced from SC

M-SDR04

S_ASSESS_VAL . SCORE

-

M-SDR05

S_ASSESS_VAL .COMMENTS

-

M-SDR06

S_ASSESS_VAL .SEQUENCE_NUM

-

M-SDR07

-

Not sourced from SC

M-SDR08

S_ASSESS_VAL . ATTRIB_NAME

-

M-SDR09

-

Not sourced from SC

M-SDR10

Impact (M-SDR04)

-

M-SDR11

S_ASSESS_VAL . WEIGHT

-

M-SDR12

Avg of child question scores

-

M-SRG36

S_CL_PTCL_LS.INIT_NUM_OF_SUBJ

-

M-SRG37

S_CL_PTCL_LS. SEL_CL_SUBJ_PCT

-

M-SRR01

-

Not sourced from SC

M-SRR02

-

Not sourced from SC

M-SRR03

-

Not sourced from SC

M-SRR04

S_ASSESS_VAL . SCORE

-

M-SRR05

S_ASSESS_VAL .COMMENTS

-

M-SRR06

S_ASSESS_VAL .SEQUENCE_NUM

-

M-SRR07

-

Not sourced from SC

M-SRR08

S_ASSESS_VAL . ATTRIB_NAME

-

M-SRR09

-

Not sourced from SC

M-SRR10

Impact (M-SRR04)

-

M-SRR11

S_ASSESS_VAL . WEIGHT

-

M-SRR12

Avg of child question scores

-

M-SSR01

-

Not sourced from SC

M-SSR02

-

Not sourced from SC

M-SSR03

-

Not sourced from SC

M-SSR04

S_ASSESS_VAL . SCORE

-

M-SSR05

S_ASSESS_VAL .COMMENTS

-

M-SSR06

S_ASSESS_VAL .SEQUENCE_NUM

-

M-SSR07

-

Not sourced from SC

M-SSR08

S_ASSESS_VAL . ATTRIB_NAME

-

M-SSR09

-

Not sourced from SC

M-SSR10

Impact (M-SSR04)

-

M-SSR11

S_ASSESS_VAL . WEIGHT

-

M-SSR12

Avg of child question scores

-

M-SST107

S_PTCL_SITE_LS.INIT_NUM_OF_SUBJ

-

M-SST108

S_PTCL_SITE_LS. SEL_CL_SUBJ_PCT

-

M-STD100

-

Not sourced from SC

M-STD101

-

Not sourced from SC

M-STD102

-

Not sourced from SC

M-STD103

-

Not sourced from SC

M-STD104

-

Not sourced from SC

M-STD105

-

Not sourced from SC

M-STD106

-

Not sourced from SC

M-STD107

-

Not sourced from SC

M-STD108

-

Not sourced from SC

M-STD109

-

Not sourced from SC

M-STD110

-

Not sourced from SC

M-STD111

-

Not sourced from SC

M-STD112

-

Not sourced from SC

M-STD113

-

Not sourced from SC

M-STD114

-

Count of all versions of a protocol that are not the original version that have been flagged as avoidable.

M-STD115

S_CL_PTCL_LS.INIT_NUM_OF_SUBJ

-

M-STD116

S_CL_PTCL_LS.SEL_CL_SUBJ_PCT

-

M-STD93

-

Not sourced from SC

M-STD94

-

Not sourced from SC

M-STD95

-

Not sourced from SC

M-STD96

-

Not sourced from SC

M-STD97

-

Not sourced from SC

M-STD98

-

Not sourced from SC

M-STD99

-

Not sourced from SC

TA-SIV12

S_EVT_ACT_LSX. REVIEWED_TS

-

TA-SIV13

S_EVT_ACT_LSX. REVIEW_COMMENTS

-

TA-SIV14

Employee Last, First Name; Join on S_EVT_ACT_LSX. REVIEWER_ID

-

TA-SIV15

Employee Last, First Name; Join on S_EVT_ACT_LSX. APPROVER_ID

-

TA-SUBJ10

S_CL_SUBJ_LS.

-

TA-SUBJ11

S_CL_SUBJ_LS .SDV_UPD_TYPE_CD

-

Oracle Health Sciences InForm Sources for OHSCDA Presentation Catalog

Table B-6 Presentation Catalog - InForm Sources

Attribute ID

Source Table/Column

Comments/Details

AD11-02

IRV_FORM_REVS.FORMNAME

-

AD11-02

IRV_FORM_REVS.FORMNAME

-

AD11-04

IRV_FORM_REVS.FORMMNEMONIC

-

AD11-01

IRV_STUDYVERSIONS.STUDYNAME

-

AD04-06

IRV_CUR_SITE_V.SITECITY UNION IRV_CUR_USER_V.USERCITY where IRV_CUR_USER_V.rightsgroup = 'PI'

-

AD04-03

IRV_CUR_SITE_V.SITECOUNTRY UNION IRV_CUR_USER_V.USERCOUNTRY where IRV_CUR_USER_V.rightsgroup = 'PI'

-

AD04-07

IRV_CUR_SITE_V.SITEPOSTALCODE UNION IRV_CUR_USER_V.USERPOSTALCODE where IRV_CUR_USER_V.rightsgroup = 'PI'

-

AD04-04

IRV_CUR_SITE_V.SITESTATEPROVINCE UNION IRV_CUR_USER_V.USERSTATEPROVINCE where IRV_CUR_USER_V.rightsgroup = 'PI'

-

AD05-05

IRV_CUR_USER_V.USERCITY

-

AD05-08

IRV_CUR_USER_V.USERCOUNTRY

-

AD05-13

IRV_CUR_USER_V.USERFIRSTNAME

-

AD05-14

IRV_CUR_USER_V.USERLASTNAME||', '||USERFIRSTNAME

-

AD05-02

IRV_CUR_USER_V.USERLASTNAME

-

AD05-03

IRV_CUR_USER_V.USERLASTNAME||', '||USERFIRSTNAME

-

AD05-01

IRV_CUR_USER_V.USERLASTNAME

-

AD05-15

IRV_CUR_USER_V.USERADDRESS1

-

AD05-12

IRV_CUR_USER_V.USERDAYPHONENUMBER

-

AD05-06

IRV_CUR_USER_V.USERPOSTALCODE

-

AD05-07

IRV_CUR_USER_V.USERSTATEPROVINCE

-

AD05-04

IRV_CUR_USER_V.USERADDRESS1

-

AD05-17

IRV_CUR_USER_V.USERADDRESS1

-

AD05-18

IRV_CUR_USER_V.USERADDRESS2

-

AD05-10

IRV_CUR_USER_V.USERDAYPHONENUMBER

-

AD18-01

IRV_CUR_USER_V.USERDAYPHONENUMBER

-

AD07-01

IRV_STUDYVERSIONS.SPONSORDRUGNAME

-

AD08-03

IRV_CUR_SITE.SITECOUNTRY

-

AD08-11

IRV_CUR_SITE.SITESTATEPROVINCE

-

AD08-02

IRV_CUR_SITE.SITESTATEPROVINCE

-

AD09-03

RXI_CUR_SPONSOR.PROGRAMNAME

-

AD09-01

IRV_STUDYVERSIONS.STUDYNAME

-

AD09-05

RXI_CUR_SPONSOR.SPONSORNAME

-

AD10-22

IRV_CUR_USER.username

-

AD10-05

IRV_CUR_SPONSOR.PROGRAMNAME

-

AD10-01

IRV_CUR_SITE.SITENAME

-

AD10-04

IRV_CUR_SITE.STUDYNAME

-

AD10-26

IRV_CUR_SPONSOR.SPONSORNAME

-

AD10-02

IVR_CUR_SITE.STUDYNAME || ':' || SITENAME

-

TD01-09

IRV_CUR_SUBJECT.SUBJECTDOB

-

TD01-06

IRV_CUR_SUBJECT.SUBJECTENROLLDATE

-

TD01-07

IRV_CUR_SUBJECT.SUBJECTSTATETEXT

-

TD01-04

IRV_CUR_SUBJECT.BOOKLOCKED

-

TD01-01

IRV_STUDYVERSIONS.STUDYNAME

-

TD01-02

IRV_CUR_SUBJECT.IRV_CUR_SUBJECT.SUBJECTNUMBERSTR

-

TD01-08

IRV_CUR_SUBJECT.SUBJECTINITIALS

-

TD01-11

IRV_CUR_SUBJECT.SUBJECTSTATETEXT

-

AD13-01

IRV_STUDYVERSIONS.STUDYNAME

-

AD13-03

IRV_CUR_RULE.RULEDESCRIPTION

-

AD13-02

IRV_CUR_RULE.RULEREFNAME

-

M-DSC03

-

-

M-DSC11

-

-

M-DSC15

-

-

M-DSC02

-

-

M-DSC01

-

-

TA-DISC09

IRV_CUR_QUERY.VISITID||'.'||VISITINDEX

-

TA-DISC13

RXI_FORM_REVS.FORMNAME

-

TA-DISC11

IRV_AF_SUBJECT_FORMS.FMINSTARTEDSTATE

-

TA-DISC12

IRV_FORM_REVS.FORMNAME

-

TA-DISC14

IRV_SECTION_REVS.SECTIONHEADER

-

TA-DISC15

IRV_ITEMSET_REVS.ITEMSETREFNAME

-

TA-DISC16

IRV_ITEM_REVS.ITEMQUESTION

-

TA-DISC21

IRV_CUR_QUERY.QUERYSTATE

-

TA-DISC26.1

IRV_CUR_QUERY.QMAXANSWERED

-

TA-DISC26

IRV_CUR_QUERY.QMAXCLOSED

-

TA-DISC30

IRV_CUR_QUERY.LASTCANDIDATETEXT,LASTOPENEDTEXT,LASTANSWEREDTEXT,LASTDELETEDTEXT,LASTCLOSEDTEXT

-

TA-DISC25

IRV_CUR_QUERY.QUERYSTATETIME

-

TA-DISC01

IRV_CUR_QUERY.QUERYID

-

TA-DISC22.1

IRV_CUR_QUERY.QUERYSTATE

-

TA-DISC22

IRV_CUR_QUERY.QUERYSTATE

-

TA-DISC04

PIRC_INV.USERLASTNAME||', '||USERFIRSTNAME

-

TA-DISC32

IRV_CUR_QUERY.QUERYTYPE

-

TA-DISC03

RXI_CUR_SITE. SITENAME

-

TA-DISC02

IRV_STUDYVERSIONS.STUDYNAME

-

TA-DISC33

IRV_CUR_SITE.STUDYNAME ||':'|| SITENAME

-

TA-DISC05

IRV_CUR_SUBJECT.SUBJECTNUMBERSTR

-

TA-DISC10

IRV_SV_SUBJECTVISITS .DOV

-

TA-DISC06

IRV_STUDYVERSION_VISITS.VISITNAME

-

TA-DISC07

IRV_CUR_QUERY.VISITID

-

TA-DISC20

IRV_CUR_RULE.IRV_CUR_RULE.RULEREFNAME

-

M-DRS03

IRV_QUERY_STATE_CHANGES.QUERYSTATE

-

M-DRS04

IRV_QUERY_STATE_CHANGES.QUERYSTATE

-

M-DRS02

IRV_QUERY_STATE_CHANGES.QUERYSTATE

-

M-DRS01

IRV_QUERY_STATE_CHANGES.QUERYSTATE

-

M-RCF18

IRV_AF_SUBJECT_FORMS.startedstate AND completestate

-

M-RCF09

IRV_AF_SUBJECT_FORMS.notdonestate

-

M-RCF01

IRV_AF_SUBJECT_FORMS.startedstate AND completestate

-

M-RCF81

IRV_AF_SUBJECT_FORMS.notdonestate

-

M-RCF68

IRV_AF_SUBJECT_FORMS.startedstate AND completestate

-

M-RCF70

IRV_AF_SUBJECT_FORMS.FMINSIGNEDSTATE

-

M-RCF69

IRV_AF_SUBJECT_FORMS.FMINSDVCOMPLETESTATE

-

M-RCF25

IRV_AF_SUBJECT_FORMS.FMINSIGNEDSTATE

-

M-RCF23

IRV_AF_SUBJECT_FORMS.FMINSDVCOMPLETESTATE

-

TA-RCRF09

IRV_AF_SUBJECT_FORMS.VISITORDER||:||VISITINDEX

-

TA-RCRF11

IRV_FORM_REVS.FORMNAME

-

TA-RCRF35

.EDC'

-

TA-RCRF01

IRV_AF_SUBJECT_FORMS.FORMORDER

-

TA-RCRF14

IRV_AF_SUBJECT_FORMS.VISIT_FIRST_ENTRY

-

TA-RCRF34

IRV_AF_SUBJECT_FORMS.CASE WHEN IRV_AF_SUBJECT_FORMS.LOCKEDSTATE = 1 AND FMAXLOCKEDSTATE IS NOT NULL THEN FMAXLOCKEDSTATE ELSE NULL;

-

TA-RCRF32

IRV_AF_SUBJECT_FORMS.FMINSIGNEDSTATE

-

TA-RCRF30

IRV_AF_SUBJECT_FORMS.FMINSDVCOMPLETESTATE

-

TA-RCRF04

IRV_CUR_USER.username

-

TA-RCRF20

IRV_AF_SUBJECT_FORMS.Case when status_code ='complete' and approval_status_code ='not signed' and initial_approval_dt is not null then 'Y' else 'N' end

-

TA-RCRF17

IRV_AF_SUBJECT_FORMS.Case when status_code ='complete' and VERFCTN_STATUS_CODE in ('SDV Partially Complete', 'Ready for SDV but Unstarted') and INITIAL_SRC_VERFCTN_DT is not null then 'Y' else 'N' end

-

TA-RCRF22

IRV_AF_SUBJECT_FORMS.NOTDONESTATE

-

TA-RCRF26

.If status_code ='Complete' then 'Y' else 'N'

-

TA-RCRF28

IRV_AF_SUBJECT_FORMS.CASE WHEN IRV_AF_SUBJECT_FORMS.LOCKEDSTATE = 1 AND FMAXLOCKEDSTATE IS NOT NULL THEN 'Y' ELSE 'N';

-

TA-RCRF19

IRV_AF_SUBJECT_FORMS.Case when status_code ='complete' and APPROVAL_STATUS_CODE = 'Nt Signed' and INITIAL_APPROVAL_DT is NULL then 'Y' else 'N' end.

-

TA-RCRF16

IRV_AF_SUBJECT_FORMS.Case when status_code = 'Complete' and INITIAL_SRC_VERFCTN_DT IS NULL 'Y' else 'N' end

-

TA-RCRF23

IRV_AF_SUBJECT_FORMS.case when IRV_AF_SUBJECT_FORMS.FROZENSTATE = 1 AND FMAXFROZENSTATE IS NOT NULL then 'Y' else 'N' end;

-

TA-RCRF33

IRV_AF_SUBJECT_FORMS.FMAXSIGNEDSTATE

-

TA-RCRF31

IRV_AF_SUBJECT_FORMS.FMAXSDVCOMPLETESTATE

-

TA-RCRF13

IRV_FORM_REVS and IRV_STUDYVERSION_VISITS.VISITNAME||':'||FORMNAME

-

TA-RCRF15

IRV_AF_SUBJECT_FORMS. INF CRF STATUS CODES:' || CASE WHEN rxi_af_subject_forms.startedstate = 0 AND rxi_af_subject_forms.completestate = 0 THEN 'Not Started' WHEN rxi_af_subject_forms.startedstate = 1 AND rxi_af_subject_forms.completestate = 0 THEN 'Started' WHEN rxi_af_subject_forms.startedstate = 1 AND rxi_af_subject_forms.completestate = 1 THEN 'Complete' WHEN rxi_af_subject_forms.startedstate = 0 AND rxi_af_subject_forms.completestate = 1 THEN 'Complete But Unstarted' END AS status_code

-

TA-RCRF03

RXI_CUR_SITE.SITENAME

-

TA-RCRF29

IRV_AF_SUBJECT_FORMS.CASE WHEN IRV_AF_SUBJECT_FORMS.FROZENSTATE = 1 AND FMAXFROZENSTATE IS NOT NULL THEN FMAXFROZENSTATE ELSE NULL;

-

TA-RCRF02

RXI_STUDYVERSIONS.STUDYNAME

-

TA-RCRF08

IRV_AF_SUBJECT_FORMS.VISITINDEX

-

TA-RCRF05

IRV_CUR_SUBJECT.SUBJECTNUMBERSTR

-

TA-RCRF10

IRV_AF_SUBJECT_FORMS.DOV

-

TA-RCRF06

IRV_STUDYVERSION_VISITS .VISITNAME

-

TA-RCRF07

IRV_AF_SUBJECT_FORMS.VISITORDER

-

M-SST04

irv_cur_subject.CASE WHEN irv_cur_subject.subjectstate = 1 THEN 'Screened' WHEN irv_cur_subject.subjectstate = 2 THEN 'Screen Failed' WHEN irv_cur_subject.subjectstate = 3 THEN 'Enroll Failed' WHEN irv_cur_subject.subjectstate = 4 THEN 'Enrolled' WHEN irv_cur_subject.subjectstate = 5 THEN 'Randomized' WHEN irv_cur_subject.subjectstate = 6 THEN 'Complete' WHEN irv_cur_subject.subjectstate = 7 THEN 'Not Complete/Dropped Out' END

-

M-SST06

irv_cur_subject.subjectstate

-

M-SST02

irv_cur_subject.MAXENROLLED

-

M-SST08

IRV_SV_SUBJECT_FORMS.VISITSCHEDULED And VISITCOMPLETE

-

M-SST05

irv_cur_subject.subjectstate

-

M-SST09

sub_event_num need to have the calculation from Two tables IRV_AF_SUBJECT_FORMS IRV_SV_SUBJECTVISITS are joined on "SUBJECTID,VISITID,VISITINDEX,Studyguid" IF (VISITSCHEDULED=1 And VISITCOMPLETE=1 Then sub_event_num=0 ) else if (VISITSCHEDULED=0 And VISITCOMPLETE=1 Then sub_event_num=1 ) Else null End.VISITSCHEDULED And VISITCOMPLETE

-

AD09-75

S_CL_PTCL_LS.OBJECTIVE_DESC

Not sourced from InForm

AD09-76

S_ASSESS. ASSESS_TMPL_NAME

Not sourced from InForm

AD09-77

S_ASSESS. LAST_UPD

Not sourced from InForm

AD09-78

S_ASSESS. NAME

Not sourced from InForm

AD09-79

S_ASSESS.DESC_TEXT

Not sourced from InForm

AD09-81

-

Not sourced from InForm

AD09-82

-

Not sourced from InForm

AD09-83

-

Not sourced from InForm

AD09-84

-

Not sourced from InForm

AD09-85

-

Not sourced from InForm

AD09-86

-

Not sourced from InForm

AD09-87

-

Not sourced from InForm

AD09-88

-

Not sourced from InForm

AD10-78

S_PTCL_SITE_LS. MAX_ENROLLMENT

Not sourced from InForm

AD10-79

S_ASSESS. ASSESS_TMPL_NAME

Not sourced from InForm

AD10-80

S_ASSESS. LAST_UPD

Not sourced from InForm

AD10-81

S_ASSESS. NAME

Not sourced from InForm

AD10-82

S_PTCL_SITE_LS. SDV_TYPE_CD

Not sourced from InForm

AD10-82

S_PTCL_SITE_LS. SDV_TYPE_CD

Not sourced from InForm

AD16-17

S_ASSESS. ASSESS_TMPL_NAME

Not sourced from InForm

AD16-18

S_ASSESS. LAST_UPD

Not sourced from InForm

AD16-19

S_ASSESS. NAME

Not sourced from InForm

AD16-20

S_ASSESS.DESC_TEXT

Not sourced from InForm

AD16-21

S_ASSESS. SCORE

Not sourced from InForm

AD17-48

S_ASSESS. ASSESS_TMPL_NAME

Not sourced from InForm

AD17-49

S_ASSESS. LAST_UPD

Not sourced from InForm

AD17-50

S_ASSESS. NAME

Not sourced from InForm

AD17-51

S_ASSESS.DESC_TEXT

Not sourced from InForm

AD18-13

-

Not sourced from InForm

AD18-14

-

Not sourced from InForm

AD18-15

-

Not sourced from InForm

AD18-16

-

Not sourced from InForm

AD18-17

-

Not sourced from InForm

AD18-18

-

Not sourced from InForm

AD18-19

-

Not sourced from InForm

AD18-20

-

Not sourced from InForm

AD18-21

-

Not sourced from InForm

AD18-22

-

Not sourced from InForm

AD23-01

-

Not sourced from InForm

AD23-02

-

Not sourced from InForm

AD23-03

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from InForm

Note: This column is a concatenation of Category + : + Question. For this measure source only the substring before the first ": " If field does not have a ":" or begins with a ":", then use the category "No Category".

AD23-04

-

Not sourced from InForm

AD23-05

-

Not sourced from InForm

AD23-07

-

Not sourced from InForm

M-PRR01

-

Not sourced from InForm

M-PRR02

-

Not sourced from InForm

M-PRR03

-

Not sourced from InForm

M-PRR04

S_ASSESS_VAL .SCORE

Not sourced from InForm

M-PRR05

S_ASSESS_VAL .COMMENTS

Not sourced from InForm

M-PRR06

S_ASSESS_VAL .SEQUENCE_NUM

Not sourced from InForm

M-PRR07

-

Not sourced from InForm

M-PRR08

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from InForm

M-PRR09

-

Not sourced from InForm

M-PRR10

Impact (M-PRR04)

Not sourced from InForm

M-PRR11

S_ASSESS_VAL . WEIGHT

Not sourced from InForm

M-PRR12

Avg of child question scores

Not sourced from InForm

M-PTL01

S_PTCL_VER_LS. AMND_VERSION

Not sourced from InForm

M-PTL02

S_PTCL_VER_LS. VER_CREATED_DT

Not sourced from InForm

M-PTL03

S_PTCL_VER_LS. ORIG_VER_FLG

Not sourced from InForm

M-PTL04

-

Not sourced from InForm

M-PTL05

-

Not sourced from InForm

M-PTL06

S_PTCL_VER_LS. COMMENTS

Not sourced from InForm

M-SDR01

-

Not sourced from InForm

M-SDR02

-

Not sourced from InForm

M-SDR03

-

Not sourced from InForm

M-SDR04

S_ASSESS_VAL . SCORE

Not sourced from InForm

M-SDR05

S_ASSESS_VAL .COMMENTS

Not sourced from InForm

M-SDR06

S_ASSESS_VAL .SEQUENCE_NUM

Not sourced from InForm

M-SDR07

-

Not sourced from InForm

M-SDR08

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from InForm

M-SDR09

-

Not sourced from InForm

M-SDR10

Impact (M-SDR04)

Not sourced from InForm

M-SDR11

S_ASSESS_VAL . WEIGHT

Not sourced from InForm

M-SDR12

Avg of child question scores

Not sourced from InForm

M-SRG36

S_CL_PTCL_LS.INIT_NUM_OF_SUBJ

Not sourced from InForm

M-SRG37

S_CL_PTCL_LS. SEL_CL_SUBJ_PCT

Not sourced from InForm

M-SRR01

-

Not sourced from InForm

M-SRR02

-

Not sourced from InForm

M-SRR03

-

Not sourced from InForm

M-SRR04

S_ASSESS_VAL . SCORE

Not sourced from InForm

M-SRR05

S_ASSESS_VAL .COMMENTS

Not sourced from InForm

M-SRR06

S_ASSESS_VAL .SEQUENCE_NUM

Not sourced from InForm

M-SRR07

-

Not sourced from InForm

M-SRR08

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from InForm

M-SRR09

-

Not sourced from InForm

M-SRR10

Impact (M-SRR04)

Not sourced from InForm

M-SRR11

S_ASSESS_VAL . WEIGHT

Not sourced from InForm

M-SRR12

Avg of child question scores

Not sourced from InForm

M-SSR01

-

Not sourced from InForm

M-SSR02

-

Not sourced from InForm

M-SSR03

-

Not sourced from InForm

M-SSR04

S_ASSESS_VAL . SCORE

Not sourced from InForm

M-SSR05

S_ASSESS_VAL .COMMENTS

Not sourced from InForm

M-SSR06

S_ASSESS_VAL .SEQUENCE_NUM

Not sourced from InForm

M-SSR07

-

Not sourced from InForm

M-SSR08

S_ASSESS_VAL . ATTRIB_NAME

Not sourced from InForm

M-SSR09

-

Not sourced from InForm

M-SSR10

Impact (M-SSR04)

Not sourced from InForm

M-SSR11

S_ASSESS_VAL . WEIGHT

Not sourced from InForm

M-SSR12

Avg of child question scores

Not sourced from InForm

M-SST107

S_PTCL_SITE_LS.INIT_NUM_OF_SUBJ

Not sourced from InForm

M-SST108

S_PTCL_SITE_LS. SEL_CL_SUBJ_PCT

Not sourced from InForm

M-STD100

-

Not sourced from InForm

M-STD101

-

Not sourced from InForm

M-STD102

-

Not sourced from InForm

M-STD103

-

Not sourced from InForm

M-STD104

-

Not sourced from InForm

M-STD105

-

Not sourced from InForm

M-STD106

-

Not sourced from InForm

M-STD107

-

Not sourced from InForm

M-STD108

-

Not sourced from InForm

M-STD109

-

Not sourced from InForm

M-STD110

-

Not sourced from InForm

M-STD111

-

Not sourced from InForm

M-STD112

-

Not sourced from InForm

M-STD113

-

Not sourced from InForm

M-STD114

-

Not sourced from InForm

Count of all versions of a protocol that are not the original version that have been flagged as avoidable.

M-STD115

S_CL_PTCL_LS.INIT_NUM_OF_SUBJ

Not sourced from InForm

M-STD116

S_CL_PTCL_LS.SEL_CL_SUBJ_PCT

Not sourced from InForm

M-STD93

-

Not sourced from InForm

M-STD94

-

Not sourced from InForm

M-STD95

-

Not sourced from InForm

M-STD96

-

Not sourced from InForm

M-STD97

-

Not sourced from InForm

M-STD98

-

Not sourced from InForm

M-STD99

-

Not sourced from InForm

TA-SIV12

S_EVT_ACT_LSX. REVIEWED_TS

Not sourced from InForm

TA-SIV13

S_EVT_ACT_LSX. REVIEW_COMMENTS

Not sourced from InForm

TA-SIV14

Employee Last, First Name; Join on S_EVT_ACT_LSX. REVIEWER_ID

Not sourced from InForm

TA-SIV15

Employee Last, First Name; Join on S_EVT_ACT_LSX. APPROVER_ID

Not sourced from InForm

TA-SUBJ10

S_CL_SUBJ_LS.

Not sourced from InForm

TA-SUBJ11

S_CL_SUBJ_LS .SDV_UPD_TYPE_CD

Not sourced from InForm

Glossary

Case Report Form

A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. The CRF is the way the Clinical Data for Patients is collected.

CDMS

Clinical Data Management System (For example, Oracle Clinical)

Central Laboratory

A location, under contract to a Clinical Trial sponsor, where samples are sent from multiple sites for analysis.

Clinical Data

Data pertaining to the medical characteristics or status of a patient or subject.

Clinical Research Organization

A company or organization that conducts all or part of a clinical trial under contract to a Clinical Trial sponsor.

Clinical Study

See Clinical Trial

Clinical Trial

Before a pharmaceutical or biotech company can initiate testing on humans, it must conduct extensive pre-clinical or laboratory research. This research typically involves years of experiments on animal and human cells. The compounds are also extensively tested on animals. If this stage of testing is successful, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug on humans. This is called an Investigational New Drug application (IND). A clinical trial is a carefully designed investigation of the effects of drug, medical treatment, or device on a group of patients (also called Subjects).

compound

The product being tested or researched within the Clinical Trial.

CRA

Clinical Research Associate. An employee of the Sponsor, responsible for getting a site prepared to conduct a trial and getting cleaned data back from the site to the Sponsor.

CRF

See Case Report Form

CRF Book

A set of paper forms or electronic forms that record the results of the set of assessments performed on a subject taking part in a clinical trial.

CRF Page

A single form within a CRF Book.

CRO

Clinical Research Organization

CTMS

Clinical Trial Management System (For example, Oracle's Siebel Clinical)

discrepancy

Problems found with data reported in the CRF pages by Investigators for specific Patients

eCRF

A single electronic CRF.

EDC

Electronic Data Capture system (For example, Oracle Remote Data Capture (RDC))

informed consent

A discussion of all procedures, benefits, risks, and expectations of a clinical trial between clinical investigators and potential patients. The FDA requires all patients to sign an informed consent form before participating in a trial.

investigator

A person responsible for the conduct of the clinical trial at a trial site. When a Clinical Trial is conducted at a Site by a team the Investigator is the responsible leader of the team and may be called Principal Investigator (PI). Other investigators are called Sub-investigators. Investigators are qualified health care professionals, often are MDs, PhDs or Pham Ds.

patient

A person who participates in a Clinical Study and is the focus of the Clinical Trial's research.

patient visits

A series of scheduled visits by a Patient to an Investigator based interval specified in the Clinical Trial's Protocol. During the Patient visits the Investigators undertakes the required medical procedures defined in the Clinical Trial Protocol and completes the corresponding CRFs.

phase

Phase of trial, typically 1,2,3 or 4.

program

Groups of Clinical Studies or Clinical Trials for the same compound.

projects

Groups of Studies within a Program (Oracle Clinical Only)

Protocol

A Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. It is a plan that states what will be done in the study and why. It outlines how many people will take part in the study, what types of Subjects may take part, what tests they will receive how often, and the treatment plan. The Sponsor of the Clinical Trial typically designs the Protocol.

Protocol amendment

A written description of a change(s) to or formal clarification of a protocol.

queries

Each query is a request for information, sent to an Investigator, to resolve a Discrepancy detected in data signed for by that Investigator.

randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

region

A geographic region in which the Clinical Study or Clinical Trial will be carried out.

Regulatory Authority

An authority such as FDA and EMEA regulating clinical development processes.

site coordinator

The individual who manages the conduct of the clinical trial. Coordinators are often nurses.

site visit

A visit or trip by a CRA to a Site for monitoring and support activities.

sites

Sites are locations where clinical trials are conducted. They are typically a clinic or hospitals where investigators see subjects and perform study procedures, such as medical checks.

Sponsor

The organization funding the clinical trial. This is typically the Pharmaceutical company whose product is being tested with the clinical trial.

study document

A required Document to initiate or start a Clinical Trial at a Site (For example, Investigator Resume.)

study

See Clinical Trial

subject

See patient

Index
A  C  D  E  F  H  I  K  L  M  N  O  P  Q  R  S  T  U  V  W

A

accessing

OCDA, 2.2

action links, 3.3 analyses

printing, 2.4.3

refreshing, 2.4.6

architecture

OCDA, 1.2

C

cache, definition, 2.4.6

Catalog, 2.3.1.1

CRA

dashboard, A.1.1

dashboard pages, A.1.1.1

CRA Overview, A.1.1.1.1

eCRF Workload, A.1.1.1.9

Initiating & Recruiting Sites, A.1.1.1.4

Monitoring Metrics, A.1.1.1.5

Performance, A.1.1.1.10

Site Document List, A.1.1.1.8

Sites to Monitor, A.1.1.1.2

Study-Site Milestones, A.1.1.1.3, A.1.1.1.6

Top Investigators, A.1.1.1.7

CRA Overview

CRA dashboard page, A.1.1.1.1

custom reports in OCDA, 3.2

D

Dashboard Page & Analysis Index

Index dashboard page, A.1.10.1.1, A.1.10.1.2

dashboard pages

CRA, A.1.1.1

CRA Overview, A.1.1.1.1

eCRF Workload, A.1.1.1.9

Initiating & Recruiting Sites, A.1.1.1.4

Monitoring Metrics, A.1.1.1.5

Performance, A.1.1.1.10

Site Document List, A.1.1.1.8

Sites to Monitor, A.1.1.1.2

Study-Site Milestones, A.1.1.1.3, A.1.1.1.6

Top Investigators, A.1.1.1.7

Data Manager - EDC, A.1.2.1

Discrepancy Workload, A.1.2.1.3

eCRF Workload, A.1.2.1.2

Home, A.1.2.1.1

Key Rates, A.1.2.1.5

Page Workload, A.1.3.1.2

Performance, A.1.2.1.6

Quality, A.1.2.1.4

Study Discrepancies, A.1.2.1.7

Study Processing Detail, A.1.2.1.9

Study Processing Summary, A.1.2.1.8

Data Manager - Paper, A.1.3.1

Discrepancy Workload, A.1.3.1.3

Home, A.1.3.1.1

Performance, A.1.3.1.5

Quality, A.1.3.1.4

Study Processing Detail, A.1.3.1.7

Study Processing Summary, A.1.3.1.6

definition, 2.1 Index, A.1.10.1

Dashboard Page & Analysis Index, A.1.10.1.1, A.1.10.1.2

Study Manager, A.1.6.1

Initiating & Recruiting Studies, A.1.6.1.2

Monitoring Metrics, A.1.6.1.3

Study Manager Overview, A.1.6.1.1

Top Investigators, A.1.6.1.4

Study Overview, A.1.7.1

Monitoring Metrics, A.1.7.1.10

Non Performing Investigators, A.1.7.1.7

Recruitment Overview, A.1.7.1.4

Retention Overview, A.1.7.1.5

Screening Overview, A.1.7.1.3

Site Document List, A.1.7.1.11

Site Document Metrics, A.1.7.1.12

Site Performance, A.1.7.1.8

Site Region Performance, A.1.7.1.9

Study Overview, A.1.7.1.1

Study-Site Milestones, A.1.7.1.2

Study-Site Overview, A.1.9.1.1

Top Investigators, A.1.7.1.6

Study-Site Overview, A.1.9.1

Monitoring Metrics, A.1.9.1.4

Retention Overview, A.1.9.1.3

Screening & Recruitment Overview, A.1.9.1.2

Site Document List, A.1.9.1.6

Site Document Metrics, A.1.9.1.7

Study-Site Team, A.1.9.1.5

Visit Reports & Follow Up Items, A.1.9.1.8

dashboards

about, A.1

CRA, A.1.1

Data Manager - EDC, A.1.2

Data Manager - Paper, A.1.3

definition, 2.1

Index, A.1.10

printing, 2.4.3

refreshing, 2.4.6

Study Manager, A.1.6

Study Overview, A.1.7

Study-Site Overview, A.1.9

viewing, 2.2.2

Data Manager - EDC

dashboard, A.1.2

dashboard pages, A.1.2.1

Discrepancy Workload, A.1.2.1.3

eCRF Workload, A.1.2.1.2

Home, A.1.2.1.1

Key Rates, A.1.2.1.5

Page Workload, A.1.3.1.2

Performance, A.1.2.1.6

Quality, A.1.2.1.4

Study Discrepancies, A.1.2.1.7

Study Processing Detail, A.1.2.1.9

Study Processing Summary, A.1.2.1.8

Data Manager - Paper

dashboard, A.1.3

dashboard pages, A.1.3.1

Discrepancy Workload, A.1.3.1.3

Home, A.1.3.1.1

Performance, A.1.3.1.5

Quality, A.1.3.1.4

Study Processing Detail, A.1.3.1.7

Study Processing Summary, A.1.3.1.6

data tracking

See tracking data

dimensions in the presentation catalog, B.1 Discrepancy Workload

Data Manager - EDC dashboard page, A.1.2.1.3

Data Manager - Paper dashboard page, A.1.3.1.3

drilling down results, 2.5.3

E

eCRF Workload

CRA dashboard page, A.1.1.1.9

Data Manager - EDC dashboard page, A.1.2.1.2

ETL programs

version management, 1.4.2

exiting, Oracle BI, 2.4.1

F

facts in the presentation catalog, B.2

filters, definition, 2.1

H

Home

Data Manager - EDC dashboard page, A.1.2.1.1

Data Manager - Paper dashboard page, A.1.3.1.1

I

Index

dashboard, A.1.10

dashboard pages, A.1.10.1

Dashboard Page & Analysis Index, A.1.10.1.1, A.1.10.1.2

Initiating & Recruiting Sites

CRA dashboard page, A.1.1.1.4

Initiating & Recruiting Studies

Study Manager dashboard page, A.1.6.1.2

introducing, OCDA, 1.1

K

Key Rates

Data Manager - EDC dashboard page, A.1.2.1.5

L

logging in, OCDA, 2.2.1

M

managing ETL versions, 1.4.2

Monitoring Metrics

CRA dashboard page, A.1.1.1.5

Study Manager dashboard page, A.1.6.1.3

Study Overview dashboard page, A.1.7.1.10

Study-Site Overview dashboard page, A.1.9.1.4

Top Investigators dashboard page, A.1.6.1.4

My Account page, using, 2.6

N

navigation in Oracle BI, 2.5

Non Performing Investigators

Study Overview dashboard page, A.1.7.1.7

O

OCDA

accessing, 2.2

architecture, 1.2

custom reports, 3.2

logging in, 2.2.1

overview, 1.1

predefined reports, 3.1

online help, using, 2.4.2 Oracle BI

drilling down, 2.5.3

exiting, 2.4.1

navigating, 2.5

setting preferences, 2.6.1

setting time zone, 2.6.2

sorting table columns, 2.5.4

using, 2.3

Oracle BI Analysis Editor, 2.3.1.2 Oracle BI Delivers, 2.3.1.5 Oracle BI features links, using, 2.5.2 Oracle BI Interactive Dashboards, 2.3.1.4 Oracle BI interactive home page, 2.3.1.3 Oracle BI Presentation Services, 2.3.1

Oracle BI Analysis Editor, 2.3.1.2

Oracle BI Delivers, 2.3.1.5

Oracle BI Interactive Dashboards, 2.3.1.4

Oracle BI interactive Home Page, 2.3.1.3

Oracle Business Intelligence Catalog, 2.3.1.1

overview, OCDA, 1.1 overview, using OCDA, 2.1

P

Page Workload

Data Manager - EDC dashboard page, A.1.3.1.2

pages

See dashboard pages, definition

parameters, definition, 2.1 patches, Preface Performance

CRA dashboard page, A.1.1.1.10

Data Manager - EDC dashboard page, A.1.2.1.6

Data Manager - Paper dashboard page, A.1.3.1.5

predefined

reports, 3.1

presentation catalog

dimensions, B.1

facts, B.2

oracle clinical sources, B.3.1

siebel clinical sources, B.4

printing dashboards and analyses, 2.4.3 prompts, definition, 3.1

Q

Quality

Data Manager - EDC dashboard page, A.1.2.1.4

Data Manager - Paper dashboard page, A.1.3.1.4

R

Recruitment Overview

Study Overview dashboard page, A.1.7.1.4

refreshing

dashboards and analyses, 2.4.6

information in selection pane, 2.4.7

regulatory compliance, 1.4

data tracking, 1.4.1

ETL version management, 1.4.2

security, 1.4.3

reporting, using OCDA, 1.3 reports

custom, 3.2

defined, 3.1

parameters, 2.1

predefined, 3.1

view, 3.1.1

view on Apple iPhone, 3.4

results

downloading, downloading results, 2.4.5

Retention Overview

Study Overview dashboard page, A.1.7.1.5

Study-Site Overview dashboard page, A.1.9.1.3

S

Screening & Recruitment Overview

Study-Site Overview dashboard page, A.1.9.1.2

Screening Overview

Study Overview dashboard page, A.1.7.1.3

security, 1.4.3 setting preferences, Oracle BI, 2.6.1 setting time zone, Oracle BI, 2.6.2 Site Document List

CRA dashboard page, A.1.1.1.8

Study Overview dashboard page, A.1.7.1.11

Site Document Metrics

Study Overview dashboard page, A.1.7.1.12

Study-Site Overview dashboard page, A.1.9.1.7

Site Performance

Study Overview dashboard page, A.1.7.1.8

Site Region Performance

Study Overview dashboard page, A.1.7.1.9

Sites to Monitor

CRA dashboard page, A.1.1.1.2

sorting table columns in Oracle BI, 2.5.4 Study Discrepancies

Data Manager - EDC dashboard page, A.1.2.1.7

Study Manager

dashboard, A.1.6

dashboard pages, A.1.6.1

Initiating & Recruiting Studies, A.1.6.1.2

Monitoring Metrics, A.1.6.1.3

Study Manager Overview, A.1.6.1.1

Top Investigators, A.1.6.1.4

Study Manager Overview

Study Manager dashboard page, A.1.6.1.1

Study Overview

dashboard, A.1.7

dashboard pages, A.1.7.1

Monitoring Metrics, A.1.7.1.10

Non Performing Investigators, A.1.7.1.7

Recruitment Overview, A.1.7.1.4

Retention Overview, A.1.7.1.5

Screening Overview, A.1.7.1.3

Site Document List, A.1.7.1.11

Site Document Metrics, A.1.7.1.12

Site Performance, A.1.7.1.8

Site Region Performance, A.1.7.1.9

Study Overview, A.1.7.1.1

Study-Site Milestones, A.1.7.1.2

Study-Site Overview, A.1.9.1.1

Top Investigators, A.1.7.1.6

Study Overview dashboard page, A.1.7.1.1 Study-Site Overview dashboard page, A.1.9.1.1 Study Processing Detail

Data Manager - EDC dashboard page, A.1.2.1.9

Data Manager - Paper dashboard page, A.1.3.1.7

Study Processing Summary

Data Manager - EDC dashboard page, A.1.2.1.8

Data Manager - Paper dashboard page, A.1.3.1.6

Study-Site Document List

Study Overview dashboard page, A.1.9.1.6

Study-Site Milestones

CRA dashboard page, A.1.1.1.3, A.1.1.1.6

Study Overview dashboard page, A.1.7.1.2

Study-Site Overview

dashboard, A.1.9

dashboard pages, A.1.9.1

Monitoring Metrics, A.1.9.1.4

Retention Overview, A.1.9.1.3

Screening & Recruitment Overview, A.1.9.1.2

Site Document List, A.1.9.1.6

Site Document Metrics, A.1.9.1.7

Study-Site Team, A.1.9.1.5

Visit Reports & Follow Up Items, A.1.9.1.8

Study-Site Team

Study-Site Overview dashboard page, A.1.9.1.5

T

Top Investigators

CRA dashboard page, A.1.1.1.7

Study Overview dashboard page, A.1.7.1.6

tracking data, 1.4.1

U

using

My Account Page, 2.6

Oracle BI, 2.3

using OCDA, 2.1 using online help, 2.4.2 using Oracle BI features links, 2.5.2

V

viewing

dashboards, 2.2.2

predefined reports, 3.1.1

reports on Apple iPhone, 3.4

saved requests, 3.6

Visit Reports & Follow Up Items

Study-Site Overview dashboard page, A.1.9.1.8

W

what can i do using Oracle Clinical Development Analytics, 1.1.1

what is available to you after accessing Oracle BI, 2.5.1

Oracle Legal Notices

Copyright Notice

Copyright © 1994-2018, Oracle and/or its affiliates. All rights reserved.

License Restrictions Warranty/Consequential Damages Disclaimer

This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited.

Warranty Disclaimer

The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing.

Restricted Rights Notice

If this is software or related documentation that is delivered to the U.S. Government or anyone licensing it on behalf of the U.S. Government, then the following notice is applicable:

U.S. GOVERNMENT END USERS: Oracle programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, delivered to U.S. Government end users are "commercial computer software" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, use, duplication, disclosure, modification, and adaptation of the programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, shall be subject to license terms and license restrictions applicable to the programs. No other rights are granted to the U.S. Government.

Hazardous Applications Notice

This software or hardware is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications that may create a risk of personal injury. If you use this software or hardware in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software or hardware in dangerous applications.

Trademark Notice

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registered trademark of The Open Group.

Third-Party Content, Products, and Services Disclaimer

This software or hardware and documentation may provide access to or information about content, products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content, products, and services unless otherwise set forth in an applicable agreement between you and Oracle. Oracle Corporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of third-party content, products, or services, except as set forth in an applicable agreement between you and Oracle.

Pre-General Availability Draft Documentation Notice

If this document is in public or private pre-General Availability status:

This documentation is in pre-General Availability status and is intended for demonstration and preliminary use only. It may not be specific to the hardware on which you are using the software. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to this documentation and will not be responsible for any loss, costs, or damages incurred due to the use of this documentation.

Private Pre-General Availability Draft Documentation Notice

If this document is in private pre-General Availability status:

The information contained in this document is for informational sharing purposes only and should be considered in your capacity as a customer advisory board member or pursuant to your pre-General Availability trial agreement only. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described in this document remains at the sole discretion of Oracle.

This document in any form, software or printed matter, contains proprietary information that is the exclusive property of Oracle. Your access to and use of this confidential material is subject to the terms and conditions of your Oracle Master Agreement, Oracle License and Services Agreement, Oracle PartnerNetwork Agreement, Oracle distribution agreement, or other license agreement which has been executed by you and Oracle and with which you agree to comply. This document and information contained herein may not be disclosed, copied, reproduced, or distributed to anyone outside Oracle without prior written consent of Oracle. This document is not part of your license agreement nor can it be incorporated into any contractual agreement with Oracle or its subsidiaries or affiliates.

Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers that have purchased support have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.