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 Health Sciences Pharmacovigilance Operational Analytics

1 Getting Started with OPVA

• 1.1 Overview
  • 1.1.1 What Can I Do Using Oracle Pharmacovigilance Operational Analytics?
• 1.2 Architecture
• 1.3 Reporting
• 1.4 Regulatory Compliance
  • 1.4.1 Tracking Data
  • 1.4.2 Managing ETL Versions
  • 1.4.3 Executing the ETLs
  • 1.4.4 Security

2 Using OPVA

• 2.1 Overview
• 2.2 Accessing Oracle Health Sciences Pharmacovigilance Operational Analytics
  • 2.2.1 Viewing a Dashboard
• 2.3 Using Oracle Business Intelligence
  • 2.3.1 Logging In
  • 2.3.2 Working with Oracle Business Intelligence
    • 2.3.2.1 Oracle Business Intelligence Interactive Dashboards
    • 2.3.2.2 Oracle Business Intelligence Analysis
    • 2.3.2.3 Oracle Business Intelligence Agents
• 2.4 Performing Common Tasks in Oracle Business Intelligence
  • 2.4.1 Signing Out of Oracle Business Intelligence Enterprise Edition
  • 2.4.2 Using Online Help
• 2.5 Navigating in Oracle Business Intelligence
  • 2.5.1 What is Available to You After Accessing Oracle BI?
  • 2.5.2 What is the OBIEE Home Page?
  • 2.5.3 What is the OBIEE Global Header?
  • 2.5.4 Setting Preferences
    • 2.5.4.1 Steps to Set Preferences
    • 2.5.4.2 Exporting the Oracle BI Results
      • 2.5.4.2.1 Add to Briefing Book
      • 2.5.4.2.2 About Briefing Books
      • 2.5.4.2.3 Adding Content to Briefing Books
    • 2.5.4.3 Sorting Options Menu and Buttons
      • 2.5.4.3.1 Sorting Mechanisms
  • 2.5.5 Drilling In Results
    • 2.5.5.1 What Is Drilling?
    • 2.5.5.2 Where Can I Drill?
      • 2.5.5.2.1 Drilling in Attribute Columns
      • 2.5.5.2.2 Drilling in Hierarchical Columns
      • 2.5.5.2.3 Drilling in Graphs
  • 2.5.6 Printing an Oracle BI Dashboard or Saved Request
  • 2.5.7 Emailing an Oracle BI Dashboard Page or Request

3 Working with Reports

• 3.1 Pre-defined Reports
  • 3.1.1 Opening and Using Dashboards
• 3.2 Custom Reports
• 3.3 Viewing Reports With Your Apple iPhone

Part II Administration

4 Extract Transform Load Programs

• 4.1 ETL Architecture
  • 4.1.1 Oracle Health Sciences Pharmacovigilance Operational Analytics Hierarchy
• 4.2 Executing the ETL Execution Plans
• 4.3 Customizing an ETL Execution Plan
• 4.4 Creating an ETL Execution Plan
• 4.5 Modifying an ETL Execution Plan
• 4.6 Scheduling an ETL Execution Plan
• 4.7 Customizable User Exits in OPVA ETLs

5 Maintaining the Repository and Warehouse

• 5.1 Maintaining the Oracle Health Sciences Pharmacovigilance Operational Analytics Repository
  • 5.1.1 Modifying the Repository
• 5.2 Maintaining the Oracle Health Sciences Pharmacovigilance Operational Analytics Data Warehouse
  • 5.2.1 Derivations
  • 5.2.2 Extensions
  • 5.2.3 Substitutions
  • 5.2.4 Modifying Data Warehouse Tables

6 Performance Considerations

• 6.1 Conformed Dimensions in OPVA
• 6.2 Aggregate Facts in OPVA
• 6.3 Creation of Prompts and Filters
  • 6.3.1 Mandatory Prompts
    • 6.3.1.1 Creating a mandatory field in page-level prompts
    • 6.3.1.2 Setting up default values
• 6.4 OBIEE Caching and Cache Seeding

7 Implementing Security

• 7.1 About Security in Oracle Health Sciences Pharmacovigilance Operational Analytics
  • 7.1.1 Example
• 7.2 Setting Up User Authentication
  • 7.2.1 Creating User Accounts in DAC
  • 7.2.2 Creating Users and Groups for OPVA
  • 7.2.3 Implementing Security using OAM and Configuring SSL for OPVA

Part III Appendices

A Dashboards and Reports

• A.1 Oracle Pharmacovigilance Operational Analytics Dashboards
  • A.1.1 Case Processing History
    • A.1.1.1 Case Processing History Dashboard Pages
      • A.1.1.1.1 Case Processing Volume History
      • A.1.1.1.2 Case Processing Compliance History
      • A.1.1.1.3 Workflow State Repetition History
  • A.1.2 Case Processing Management
    • A.1.2.1 Case Processing Management Dashboard Pages
      • A.1.2.1.1 Case Processing Volume Management
      • A.1.2.1.2 Case Processing Compliance Management
      • A.1.2.1.3 Workflow State Compliance Management
  • A.1.3 Personal User Dashboard
    • A.1.3.1 Personal User Dashboard Pages
      • A.1.3.1.1 Personal User Case History
      • A.1.3.1.2 Personal User Case Management
• A.2 Oracle Pharmacovigilance Operational Analytics Reports
  • A.2.1 Completed Case Versions - Volume Overview
    • A.2.1.1 Audience
    • A.2.1.2 Report Type
    • A.2.1.3 Location
    • A.2.1.4 Dimensions
    • A.2.1.5 Supplementary Prompts
    • A.2.1.6 Reports Referenced
    • A.2.1.7 Reports Referencing This Report
    • A.2.1.8 Column Descriptions
  • A.2.2 Completed Case Versions – Volume Trend
    • A.2.2.1 Audience
    • A.2.2.2 Report Type
    • A.2.2.3 Location
    • A.2.2.4 Dimensions
    • A.2.2.5 Supplementary Prompts
    • A.2.2.6 Reports Referenced
    • A.2.2.7 Reports Referencing This Report
    • A.2.2.8 Column Descriptions
  • A.2.3 Completed Case Versions – Line Listing
    • A.2.3.1 Audience
    • A.2.3.2 Report Type
    • A.2.3.3 Location
    • A.2.3.4 Dimensions
    • A.2.3.5 Supplementary Prompts
    • A.2.3.6 Reports Referenced
    • A.2.3.7 Reports Referencing This Report
    • A.2.3.8 Column Descriptions
  • A.2.4 Completed Case Versions – Lock Compliance Overview
    • A.2.4.1 Audience
    • A.2.4.2 Report Type
    • A.2.4.3 Location
    • A.2.4.4 Dimensions
    • A.2.4.5 Supplementary Prompts
    • A.2.4.6 Reports Referenced
    • A.2.4.7 Reports Referencing This Report
    • A.2.4.8 Column Descriptions
  • A.2.5 Completed Case Versions – Lock Compliance Proportion
    • A.2.5.1 Audience
    • A.2.5.2 Report Type
    • A.2.5.3 Location
    • A.2.5.4 Dimensions
    • A.2.5.5 Supplementary Prompts
    • A.2.5.6 Reports Referenced
    • A.2.5.7 Reports Referencing This Report
    • A.2.5.8 Column Descriptions
  • A.2.6 Completed Case Versions – Lock Compliance Trend
    • A.2.6.1 Audience
    • A.2.6.2 Report Type
    • A.2.6.3 Location
    • A.2.6.4 Dimensions
    • A.2.6.5 Supplementary Prompts
    • A.2.6.6 Reports Referenced
    • A.2.6.7 Reports Referencing This Report
    • A.2.6.8 Column Descriptions
  • A.2.7 Completed Workflow States – Line Listing
    • A.2.7.1 Audience
    • A.2.7.2 Report Type
    • A.2.7.3 Location
    • A.2.7.4 Dimensions
    • A.2.7.5 Supplementary Prompts
    • A.2.7.6 Reports Referenced
    • A.2.7.7 Reports Referencing This Report
    • A.2.7.8 Column Descriptions
  • A.2.8 Completed Case Version Routing – Line Listing
    • A.2.8.1 Audience
    • A.2.8.2 Report Type
    • A.2.8.3 Location
    • A.2.8.4 Dimensions
    • A.2.8.5 Supplementary Prompts
    • A.2.8.6 Reports Referenced
    • A.2.8.7 Reports Referencing This Report
    • A.2.8.8 Column Descriptions
  • A.2.9 Repeated Workflow States – Volume Overview
    • A.2.9.1 Audience
    • A.2.9.2 Report Type
    • A.2.9.3 Location
    • A.2.9.4 Dimensions
    • A.2.9.5 Supplementary Prompts
    • A.2.9.6 Reports Referenced
    • A.2.9.7 Reports Referencing This Report
    • A.2.9.8 Column Descriptions
  • A.2.10 Repeated Workflow States – Volume Proportion
    • A.2.10.1 Audience
    • A.2.10.2 Report Type
    • A.2.10.3 Location
    • A.2.10.4 Dimensions
    • A.2.10.5 Supplementary Prompts
    • A.2.10.6 Reports Referenced
    • A.2.10.7 Reports Referencing This Report
    • A.2.10.8 Column Descriptions
  • A.2.11 Pending Cases – Volume Overview
    • A.2.11.1 Audience
    • A.2.11.2 Report Type
    • A.2.11.3 Location
    • A.2.11.4 Dimensions
    • A.2.11.5 Supplementary Prompts
    • A.2.11.6 Reports Referenced
    • A.2.11.7 Reports Referencing This Report
    • A.2.11.8 Column Descriptions
  • A.2.12 Pending Cases – Line Listing
    • A.2.12.1 Audience
    • A.2.12.2 Report Type
    • A.2.12.3 Location
    • A.2.12.4 Dimensions
    • A.2.12.5 Supplementary Prompts
    • A.2.12.6 Reports Referenced
    • A.2.12.7 Reports Referencing This Report
    • A.2.12.8 Column Descriptions
  • A.2.13 Pending Cases – Lock Compliance Overview
    • A.2.13.1 Audience
    • A.2.13.2 Report Type
    • A.2.13.3 Location
    • A.2.13.4 Dimensions
    • A.2.13.5 Supplementary Prompts
    • A.2.13.6 Reports Referenced
    • A.2.13.7 Reports Referencing This Report
    • A.2.13.8 Column Descriptions
  • A.2.14 Pending Cases – Lock Compliance In Days
    • A.2.14.1 Audience
    • A.2.14.2 Report Type
    • A.2.14.3 Location
    • A.2.14.4 Dimensions
    • A.2.14.5 Supplementary Prompts
    • A.2.14.6 Reports Referenced
    • A.2.14.7 Reports Referencing This Report
    • A.2.14.8 Column Descriptions
  • A.2.15 Pending Workflow States – Compliance Overview
    • A.2.15.1 Audience
    • A.2.15.2 Report Type
    • A.2.15.3 Location
    • A.2.15.4 Dimensions
    • A.2.15.5 Supplementary Prompts
    • A.2.15.6 Reports Referenced
    • A.2.15.7 Reports Referencing This Report
    • A.2.15.8 Column Descriptions
  • A.2.16 My Completed Workflow States – Volume Trend
    • A.2.16.1 Audience
    • A.2.16.2 Report Type
    • A.2.16.3 Location
    • A.2.16.4 Dimensions
    • A.2.16.5 Supplementary Prompts
    • A.2.16.6 Reports Referenced
    • A.2.16.7 Reports Referencing This Report
    • A.2.16.8 Column Descriptions
  • A.2.17 My Repeated Workflow States – Volume Overview
    • A.2.17.1 Audience
    • A.2.17.2 Report Type
    • A.2.17.3 Location
    • A.2.17.4 Dimensions
    • A.2.17.5 Supplementary Prompts
    • A.2.17.6 Reports Referenced
    • A.2.17.7 Reports Referencing This Report
    • A.2.17.8 Column Descriptions
  • A.2.18 My Completed Case Versions – Line Listing
    • A.2.18.1 Audience
    • A.2.18.2 Report Type
    • A.2.18.3 Location
    • A.2.18.4 Dimensions
    • A.2.18.5 Supplementary Prompts
    • A.2.18.6 Reports Referenced
    • A.2.18.7 Reports Referencing This Report
    • A.2.18.8 Column Descriptions
  • A.2.19 My Completed Workflow States – Line Listing
    • A.2.19.1 Audience
    • A.2.19.2 Report Type
    • A.2.19.3 Location
    • A.2.19.4 Dimensions
    • A.2.19.5 Supplementary Prompts
    • A.2.19.6 Reports Referenced
    • A.2.19.7 Reports Referencing This Report
    • A.2.19.8 Column Descriptions
  • A.2.20 My Pending Cases – Overview
    • A.2.20.1 Audience
    • A.2.20.2 Report Type
    • A.2.20.3 Location
    • A.2.20.4 Dimensions
    • A.2.20.5 Supplementary Prompts
    • A.2.20.6 Reports Referenced
    • A.2.20.7 Reports Referencing This Report
    • A.2.20.8 Column Descriptions
  • A.2.21 My Assigned Cases – Line Listing
    • A.2.21.1 Audience
    • A.2.21.2 Report Type
    • A.2.21.3 Location
    • A.2.21.4 Dimensions
    • A.2.21.5 Supplementary Prompts
    • A.2.21.6 Reports Referenced
    • A.2.21.7 Reports Referencing This Report
    • A.2.21.8 Column Descriptions
  • A.2.22 My Unassigned Cases – Line Listing
    • A.2.22.1 Audience
    • A.2.22.2 Report Type
    • A.2.22.3 Location
    • A.2.22.4 Dimensions
    • A.2.22.5 Supplementary Prompts
    • A.2.22.6 Reports Referenced
    • A.2.22.7 Reports Referencing This Report
    • A.2.22.8 Column Descriptions
  • A.2.23 Other Assigned Cases – Line Listing
    • A.2.23.1 Audience
    • A.2.23.2 Report Type
    • A.2.23.3 Location
    • A.2.23.4 Dimensions
    • A.2.23.5 Supplementary Prompts
    • A.2.23.6 Reports Referenced
    • A.2.23.7 Reports Referencing This Report
    • A.2.23.8 Column Descriptions
  • A.2.24 My Completed Case Version Routing – Line Listing
    • A.2.24.1 Audience
    • A.2.24.2 Report Type
    • A.2.24.3 Location
    • A.2.24.4 Dimensions
    • A.2.24.5 Supplementary Prompts
    • A.2.24.6 Reports Referenced
    • A.2.24.7 Reports Referencing This Report
    • A.2.24.8 Column Descriptions

B OPVA Presentation Catalog

• B.1 Dimensions in OPVA Presentation Catalog
• B.2 Facts in OPVA Presentation Catalog
• B.3 Oracle Argus Safety Sources for OPVA Presentation Catalog

C Troubleshooting

• C.1 Verify whether the DAC client is able to use Informatica commands
• C.2 Unable to run Informatica Workflow from DAC
• C.3 Aborting a Workflow
• C.4 Unable to Sign In to OPVA

Index