Learn how to set up SAR aggregate reports in Safety Workbench.
About Workbench SARs
Vault Safety Workbench provides Serious Adverse Reactions (SAR) authoring and table generation capabilities.
This page describes the different SAR views and their data when generated by a user.
About Provisioned SAR Views
Safety Workbench includes some preconfigured SAR views that you can provision for your Vault. If you would like these views added to your Vault, contact your Veeva Representative.
The following table describes the available SAR views:
| View Type | View Name | Description |
| Principal View | SAR Principal | Returns all Case versions that qualify for the SAR report. |
| Workbench View | SAR Principal > Latest Version | Returns a list of the latest Case versions that qualify for the SAR report from the SAR Principal view. |
| Workbench View | SAR Principal > Latest Version > Line Listing | Returns a Case listing of the latest Case versions that qualify for the SAR report from the SAR Principal view. |
| Workbench View | SAR Principal > Latest Version > PT tabulation | Returns a list of the latest Case versions, organized by MedDRA Preferred Term (PT) that qualify for the SAR report from the SAR Principal view. |
| Workbench View | SAR Principal > Latest Version > SOC, PT tabulation | Returns a list of the latest Case versions, organized by Social Organ Class (SOC) and then by PT that qualify for the SAR report from the SAR Principal view. |
Note: If these views have been added to your Vault, do not update them without first talking to a Veeva Representative.
SAR Criteria
Vault uses the SAR Principal view to assess each Case. To qualify for the SAR report, each returned Case must meet the following criteria:
- One (1) of the following are met:
- Contains at least one (1) Product defined by the product filter in the SAR Principal view.
- Contains at least one (1) Study defined by the study filter.
- One (1) of the following are met:
- Report Type is set to Study (E2B Code=
2) and Study Type is set to Clinical Trial (E2B Code=1). - Report Type is set to Study (E2B Code=
2), Study Type is left blank or is set to a non-valid E2B value, and Literature is not set to Yes.
- Report Type is set to Study (E2B Code=
- Contains at least one (1) SAR. This is when at least one (1) event on the Case is serious and related to a Study Drug Role of IMP, Comparator, Placebo, or blank.