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Oracle® Clinical Development Analytics User and Administrator Guide
Release 2.0.0.2
Part Number E18162-03
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Contents
List of Figures
List of Tables
Title and Copyright Information
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 Clinical Development Analytics
1
Getting Started with Oracle Clinical Development Analytics
Overview
What Can I Do Using Oracle Clinical Development Analytics?
Architecture
Reporting
Regulatory Compliance
Tracking Data
Managing ETL Versions
Security
2
Using Oracle Clinical Development Analytics
Overview
Accessing Oracle Clinical Development Analytics
Logging In
Viewing a Dashboard
Using Oracle Business Intelligence
Oracle Business Intelligence Presentation Services Components
Oracle Business Intelligence Answers
Oracle Business Intelligence Interactive Dashboards
Oracle Business Intelligence Delivers
Performing Common Tasks in Oracle Business Intelligence
Exiting from Oracle Business Intelligence
Viewing Descriptions of Oracle BI Dashboards and Saved Requests
Using Online Help
Printing an Oracle BI Dashboard or Saved Request
Emailing an Oracle BI Dashboard Page or Request
Downloading Oracle BI Results
Refreshing an Oracle BI Interactive Dashboard or Oracle BI Request
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 Feature Links
Working with Oracle BI Pages
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 Reports
Predefined Reports
Viewing a Predefined Report
Custom Reports
Action Links
Viewing Reports With Your Apple iPhone
About Oracle BI Answers
Example of an Oracle BI Answers Start Page
Using Oracle BI Answers to Create, Modify, and Save Requests
Accessing Subject Areas and Requests Using the Oracle BI Answers Start Page
Accessing the Tabs in the Oracle BI Answers Workspace
Running a Request from the Oracle BI Answers Start Page
Creating a New Oracle BI Request or Changing the Criteria for an Existing Request
Specifying the Sort Order for Columns in Oracle BI Requests
Refreshing Information in the Oracle BI Answers Selection Pane
Viewing and Working with Oracle BI Answers Results
Saving an Oracle BI Request to a Personal or Shared Folder
Embedding an Oracle BI Request in an Oracle BI Dashboard
Using Variables to Display Values in Request Results and Dashboards
About Session, Repository, and Presentation Variables
Referencing Session Variables
Syntax for Referencing Session Variables
Syntax for Referencing Repository and Presentation Variables
Referencing Predefined Variables
Part II Administration
4
Maintaining the Repository and Warehouse
Maintaining the Oracle Clinical Development Analytics Repository
Modifying the Repository
Details for Selected Modifications
Merging Changes Into a New Oracle-supplied Repository
Maintaining the Oracle Clinical Development Analytics Data Warehouse
Derivations
Extensions
Substitutions
Modifying Data Warehouse Tables
5
Extract Transform Load Programs
ETL Architecture
Adding a New Data Source
Oracle Clinical Development Analytics Domain Structure in Oracle Life Sciences Data Hub
Executing the ETL Programs
Customizing an ETL Program
Creating an ETL Program
Modifying an ETL Program
Customizing the Pooling Program
Scheduling an ETL Program
Setting Up the Target Load Type
6
Implementing Security
About Security in Oracle Clinical Development Analytics
Example
Setting Up User Authentication
Creating User Accounts
Creating Database Accounts
Setting Up User Authorization
Using Predefined User Groups in OBIEE and Creating New Ones
Predefined OBIEE User Groups
Creating User Groups in OBIEE
Assigning OBIEE User Groups to Dashboards and Reports
Creating User Groups in Oracle LSH
Creating Roles in Oracle LSH
Role for OCDA End User Groups
Role for OCDA Programmers
Roles for LSH Programmers
Roles for Administrators
Assigning Roles to Oracle LSH User Groups
Assigning Oracle LSH User Groups to Objects
Assigning Users to Oracle LSH User Groups
Example Summary
Setting Up Study and Study Site Data Access for Users
Setting the Systemwide Access Variables
Data Access Tables
Importing Study and Study Site Data Access Privileges
Modifying the Data Access Programs
Running the Template Data Access Control ETL Programs
Study-Site Access Example
Part III Appendixes
A
Dashboards and Reports
Oracle Clinical Development Analytics Dashboards
CO - Document Management
CO - Document Management Dashboard Pages
CO - Site and Recruitment Overview
CO - Site and Recruitment Overview Dashboard Pages
CO - Study and Region Overview
CO - Study and Region Overview Dashboard Pages
CO - Subject Retention
CO - Subject Retention Dashboard Pages
CRA EDC Dashboard
CRA EDC Dashboard Pages
DM EDC Dashboard
DM EDC Dashboard Pages
DM Paper Dashboard
DM Paper Dashboard Pages
Oracle Clinical Development Analytics Reports
Approval & Verification Rates - Worst 25 (Report CDA-DM-350)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Average Days from Complete to Initially Approved - Top 25 (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 - Top 25 (Report CDA-DM-330)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Average Duration in Categorized Discrepancy Review Status (Report CDA-DM-210)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Average Duration of Currently Open Discrepancies, by Site (Report CDA-DM-205)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Average Duration of Open Discrepancies in Review Statuses (Report CDA-DM-215)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Comparative Site Enrollment Status Table (Report 8SDP-3)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Count of Currently Open Discrepancies by CRF and Type - Top 10 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, 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, 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, by Procedure (Report CDA-DM-235)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Discrepancies per Pages Entered - Top 25 (Report CDA-DM-255)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Discrepancies per Subjects Enrolled - Top 25 (Report CDA-DM-250)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Discrepancy Overview with Ratios (Report CDA-DM-240)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Document Collection Cycle Times - Days Outstanding by Type (Report 3SS04-1b)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Document Collection Cycle Times Table (Report 3SS04-1)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Document Collection Cycle Times -Turn Around Time by Type (Report 3SS04-1c)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Documents List (Report 8SDP-1)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Enrollment Overview By Region Chart (Report 8SDP-10b)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Enrollment Overview By Site (Report 8SDP-10)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Enrollment Progress Over Time (Report 4PR01-2)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
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
List Discrepancy Details (Report CDA-DM-245)
Audience
Report Type
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 25 (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 25 (Report CDA-DM-340)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Outstanding Documents by Category, Type (Report 8SDP-2)
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 Cycle Times - 25 Longest (Report CDA-DM-415)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Patient Retention Table (Report 5SC01-1)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Planned Sites vs. Sites Screening & Enrolling Chart (Bottom 10) (Report 3SS02-1d)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Planned Sites vs. Sites Screening & Enrolling Chart (Top 10) (Report 3SS02-1b)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Randomization Overview By Region Chart (Report 8SDP-30)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Randomization Overview By Site Table (Report 8SDP-29)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Screen Failure Reason by Site Chart (Top 10 # Screen Failures) (Report 4PR02-1c)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Screen Failure Reason Chart (Report 4PR02-1b)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Screen Failure Reason Counts by Site Table (Report 4PR02-1)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Screening Overview By Region Chart (Report 8SDP-28)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Site Detail Table (Report 3SS02-3)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Site Status by Region Chart (Report 3SS07-2)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Subject Retention Over Time Chart (Report 8SDP-4)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Subjects who Failed Screening Table (Report 8SDP-24)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Subjects Withdrawn List Table (Report 8SDP-26)
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
Withdrawn Reason Chart (Report 4PR02-2)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Withdrawn Reason Counts by Site Table (Report 4PR02-2b)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
Withdrawn Reason Overview Chart (Top 10 # Early Terms) (Report 8SDP-25)
Audience
Report Type
Location
Dimensions
Supplementary Prompts
Reports Referenced
Reports Referencing This Report
Column Descriptions
B
Oracle Clinical Development Analytics Presentation Catalog
Dimensions in OCDA Presentation Catalog
Facts in OCDA Presentation Catalog
Oracle Clinical Sources for OCDA Presentation Catalog
Oracle Clinical Sources
Aliases
Oracle's Siebel Clinical Sources for OCDA Presentation Catalog
C
Troubleshooting
Sorting and Displaying of Null Values in Reports
Cancelling Jobs in Oracle Life Sciences Data Hub
Glossary
Index