Learn how to configure your Vault to only consider causal assessments related to Investigational Products in the DSUR and PBRER.
About the Feature
With the 23R2 release, you can configure your Safety Vault to consider only Case Assessment Results for Study Products that are blinded or have a Study Product Role of Investigational, Placebo, or Active Comparator when deciding if a Case should be included in the DSUR and PBRER Serious Adverse Reaction listings and tabulations. For any applicable Study Product, Vault includes the Case if the Causality Established field is set to Yes or is blank. Previously, Vault considered all assessments for causality and all adverse event counts to determine if a Case should be included in the Serious Adverse Reaction listings.
24R1 Update: DSUR and PBRER: Cumulative Tabulations for all IMP, Comparator, Placebo and Blinded Case Study Products
With the 24R1 release, Vault extends this feature to the Cumulative Tabulation of Serious Adverse Events when determining the appropriate column for case counting. In addition, when this feature is enabled, Vault considers all the Study Products on the Case, not just the primary Case Product.
For more information, see:
- Create DSUR Aggregate Reports
- Create PBRER Aggregate Reports
- Investigational Product Causality on SAE Tabulations (DSUR and PBRER)
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.