5 Periodic Benefit Risk Assessment Report
In this chapter:
- 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