About the Feature
Vault Safety can be configured to only consider Case Assessment Results for the Investigational, Placebo, Active Comparator, and Blinded Study Products when deciding if a Case should be included in the DSUR and PBRER Serious Adverse Reaction listings and tabulations. Previously, Vault Safety considered all assessments for causality and all adverse event counts to determine if a Case should be included in the Serious Adverse Reaction listings.
This feature ensures that Vault Safety only considers causal assessments related to Investigational Products in the DSUR and PBRER.
See the ‘Causality Established is Yes or Blank on Any Case Assessment’ sections on Create DSUR Aggregate Reports and Create PBRER Aggregate Reports for more information.
Configure the Aggregate Report Settings
To enable this feature for DSUR and PBRER, complete the following steps.
- Go to Admin > Settings > Aggregate Report Settings.
- Select Edit and then select the Only Include Investigational Products for SAR checkbox.
- Select Save.
