About the Feature
In the 23R2 release, Vault Safety introduces a Drug Roles to Include report parameter for DSUR and PBRER. This report parameter affects the following tabulations:
- Interval Line Listings of Serious Adverse Reactions
- List of Subjects Who Died During the Reporting Period
- Cumulative Tabulation of Serious Adverse Events From Clinical Trials
- Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials
Previously, these tabulations included all drug roles (Suspect, Drug Not Administered, Interacting, Similar Device, Treatment, and Concomitant). Now you can specify which drug roles to include in these tabulations based on business requirements.
For more information, see Create DSUR Aggregate Reports: Drug Roles to Include Field and Create PBRER Aggregate Reports: Drug Roles to Include Field.
Configure the Aggregate Report Page Layout
- Go to Admin > Configuration > Objects > Aggregate Report.
- Go to the Page Layouts tab and select the Aggregate Report Detail Page Layout.
- In the Details section, add the Drug Roles to Include field above the Documents to Generate field.
- Select Save.
