Learn how to set up PADER aggregate reports in Safety Workbench.
About Workbench PADERs
Vault Safety Workbench provides U.S. Periodic Adverse Drug Experience Report (PADER) authoring and table generation capabilities.
This page describes the different PADER views and their data when generated by a user, as well as how to set up Aggregate Reporting Groups and their respective Product Registrations and Study Registrations.
About Provisioned PADER Views
Safety Workbench includes some preconfigured PADER 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 PADER views:
| View Type | View Name | Description |
| Principal View | PADER Principal View | Returns all Case versions that qualify for the PADER, including nullified and voided Cases. |
| Workbench View | PADER Principal > Latest Version (Excluding Nullified Cases) | Returns a list of the latest Case versions from the PADER Principal View. Excludes nullified and voided Cases. |
| Workbench View | PADER Principal > Latest Version (Including Nullified Cases) | Returns a list of the latest Case versions from the PADER Principal View. Includes nullified and voided Cases. |
| Workbench View | PADER Principal > Latest Version (Excluding Nullified Cases) > Non Primary Suspect Products | A line listing report that returns the latest Case versions with non-primary Products in the Aggregate Reporting Group. Excludes nullified and voided Cases. |
| Workbench View | PADER Principal > Latest Version (Including Nullified Cases) > Non Primary Suspect Products | A line listing report that returns the latest Case versions with non-primary Products in the Aggregate Reporting Group. Includes nullified and voided Cases. |
| Workbench View | PADER Principal > Latest Version (Excluding Nullified Cases) > 15 Day Non-15 Day Tabulation | Returns Adverse Event counts grouped by Report Type and categorized by initial Case, Follow-up Case, Seriousness, and Labeledness. Excludes nullified and voided Cases. |
| Workbench View | PADER Principal > Latest Version (Including Nullified Cases) > 15 Day Non-15 Day Tabulation | Returns Adverse Event counts grouped by Report Type and categorized by initial Case, Follow-up Case, Seriousness, and Labeledness. Includes nullified and voided Cases. |
| Workbench View | PADER Principal > Latest Version (Excluding Nullified Cases) > Summary Tabulation of ADR's | Returns the Adverse Event counts grouped by SOC and PT MedDRA levels and categorized by domestic Cases, foreign Cases, Seriousness, and Labeledness. Excludes nullified and voided Cases. |
| Workbench View | PADER Principal > Latest Version (Including Nullified Cases) > Summary Tabulation of ADR's | Returns the Adverse Event counts grouped by SOC and PT MedDRA levels and categorized by domestic Cases, foreign Cases, Seriousness, and Labeledness. Includes nullified and voided Cases. |
Note: If these views have been added to your Vault, do not update them without first talking to a Veeva Representative.
Configure Aggregate Reporting Groups
Aggregate Reporting Groups define which Product Registrations and Study Registrations to include on the Workbench aggregate report. Once you configure the Aggregate Reporting Group, it will synchronize with Safety Workbench in the daily data refresh.
To create Aggregate Reporting Groups:
- Navigate to Business Admin > Objects > Aggregate Reporting Groups.
- Select Create.
- Complete the following information:
- Name: Enter a name for the Aggregate Reporting Group.
- Aggregate Report Type: From the drop-down, select the aggregate report types this group applies to.
- Select Save or Save + Create to save this group and create another.
On the newly created Aggregate Reporting Group, expand the sections below to add records.
Product Registrations
To add Product Registrations:
- Select Add.
- In the Search: Product Registration window, use the search bar or filters to refine your search.
- Select from the existing list or create Product Registrations as needed.
- Select OK.
Study Registrations
To add Study Registrations:
- Select Add.
- In the Search: Product Registration window, use the search bar or filters to refine your search.
- Select from the existing list or create Study Registrations as needed.
- Select OK.
Aggregate Reports
Note: The Aggregate Reports section on the Aggregate Reporting Group record applies to Safety aggregate reports only.
To add a Workbench PADER to an Aggregate Reporting Group:
- Navigate to the Workbench > Ad Hoc Reports tab.
- Select a PADER and select Edit.
- Do one (1) of the following:
- Expand the Filters section and populate the Aggregate Reporting Group Name filter value.
- Create the Aggregate Reporting Group Name filter if it does not yet exist: (filter) Aggregate Reporting Group Name (operator) equals (value) [Aggregate Reporting Group].
- Select Save.