Table of Contents
- Title and Copyright Information
- Preface
-
1
Oracle Analytics Publisher and the Oracle Argus Safety Application
- Enable the Oracle Analytics Publisher Aggregate Reporting
- Configure the Argus OAS Integration
- Report Execution Flow from Oracle Analytics Publisher and Oracle Argus Safety
- Periodic Configuration Identification of Oracle Analytics Publisher Parameters
- Generate and Modify a Case Series
- Run Oracle Analytics Publisher Reports through Oracle Argus Safety
- Run Reports through Oracle Analytics Publisher Console
- Run Reports through Oracle Analytics Publisher Scheduler
- Data Security
- Report Output Management
- Viewing Aggregate Reports from Oracle Argus Safety
- Background Periodic Report Status
- 2 Aggregate Reporting Data Model
- 3 Reporting Algorithms
- 4 Oracle Argus Insight Compatibility
-
5
Periodic Benefit Risk Assessment Report
- Report Objective
- Configure Oracle Argus Safety for PBRER
- PBRER Section 6.2 - Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials
- PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources
- Sample Report
- Execute the PBRER from Oracle Analytics Publisher
- 6 Development Safety Update Report
- 7 Post Marketed Aggregate Report
- A Report Parameters and their Definitions