Table of Contents
- Title and Copyright Information
- Preface
-
1
Oracle Business Intelligence Publisher and the Oracle Argus Safety Application
- Enable the Oracle Business Intelligence Publisher Aggregate Reporting
- Configure the Argus BIP Integration
- Report Execution Flow from Oracle Business Intelligence Publisher and Oracle Argus Safety
- Periodic Configuration Identification of Oracle Business Intelligence Publisher Parameters
- Generate and Modify a Case Series
- Run Oracle Business Intelligence Publisher Reports through Oracle Argus Safety
- Run Reports through Oracle InForm Publisher Console
- Run Reports through Oracle Business Intelligence 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 Business Intelligence Publisher
- 6 Development Safety Update Report
-
7
Post Marketed Aggregate Report
- Report Objective and Sections
- PMAR Sections
- Oracle Argus Safety Configuration (PSUR) for PMAR
- Main Line Listing
- Line Listing Columns
- Summary Columns for Count
- Report Format
- HCP Summary Tabulation Columns
- Summary Tabulation for Consumer Cases
- Format for Clinical Trial Summary Tabulations
- Execute a PMAR from Oracle Business Intelligence Publisher
- A Report Parameters and their Definitions