PBRER Section 6.2 - Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials
To support Section 6.2 in PBRER in tabulating based on medicinal product, active comparators, and placebo, the Oracle Argus Safety Console Study Configuration is used to identify a product type as Placebo, Comparator, or an Investigational Medicinal Product. The Oracle Argus Safety Console Study Configuration classifies the counts of the various product types.
The system evaluates the list of cases applicable under Section 6.2 using the criteria described in the following sections and the configuration options from the ICH PSUR Configuration tab > Summary Tabulations > PBRER Section 6.2 - Cumulative Summary Tabulations tab for SAEs from clinical trials.
When the Include Section 6.2 option is selected in the ICH PSUR Configuration screen, the application evaluates the list of cases applicable for this section by the following logic:
- The application uses the main inclusion criteria on the ICH PSUR Configuration screen to generate the main case series and all the cases corresponding to the configured product to generate the cumulative case series. If multiple products are configured in the PSUR Configuration screen, the application retrieves the cases for all the configured products.
- The application uses the main inclusion criteria on the ICH PSUR Configuration screen to identify the serious study cases which are used to calculate the event counts for section 6.2.
For more information, see: