Enable Enhanced SAR Line Listing Review for DSUR and PBRER

Learn how to enable your Vault to improve clarity for the DSUR and PBRER Serious Adverse Reaction (SAR) Line Listings.

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About the Feature

This feature improves clarity when reviewing the DSUR and PBRER Interval Line Listings of Serious Adverse Reactions (SAR) by displaying the following additional relevant information and styling enhancements:

  • The report now displays Case Assessment Results in the Comments column for each listed product and event.
  • A Trial Number row groups the System Organ Class (SOC) terms and Cases below it.
  • The report displays subtotals of Cases for each Trial and SOC and a grand total of Cases.
  • The report applies shading to the Trial # row and includes a line to separate multiple products within the same Case.

For more information see the Interval Line Listings of Serious Adverse Reactions sections of the DSUR and PBRER aggregate reports.

The following section describes how to enable this feature in your Vault.

Enable the Feature

Complete the following steps to enable this feature in your Vault:

  1. Go to Admin > Settings > Aggregate Report Settings.
  2. Select Edit.
  3. In the DSUR / PBRER section, select the Display Assessment Results and Case Totals on SAR Line Listings checkbox.
  4. Select Save.