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