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 the 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 criteria described in the following sections and configuration options from the ICH PSUR Configuration tab -> Summary Tabulations -> PBRER Section 6.2 - Cumulative Summary Tabulations tab for SAEs from clinical trials.

For more information, see:

• Generate the Case Series for Section 6.2
  
• Grand Totals
  
• Section 6.2 Layout