Learn how to set up PADER aggregate reports in Safety Workbench.
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. For more information about how to create Workbench PADERs, see Create Workbench PADER Aggregate Reports.
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 | Returns a list of the latest Case versions from the PADER Principal View. |
| Workbench View | PADER Principal > Latest Version > 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. |
| Workbench View | PADER Principal > Latest Version > 15-Day Report Line Listing Summary | Summary counts of 15 day Cases and Submissions broken down by initial/follow-up. |
| Workbench View | PADER Principal > Latest Version > Case Series | Case listing of all Cases on the PADER in a flattened Excel format. |
| Workbench View | PADER Principal > Latest Version > Cases under other NDA's | A line listing report that returns Cases that were submitted to the FDA under a registration other than that in the Aggregate Reporting Group1. |
| Workbench View | PADER Principal > Latest Version > List of Death Cases | Case listing of Death Cases. |
| Workbench View | PADER Principal > Latest Version > List of Nullified Cases | Case listing of Nullified cases during the reporting interval. |
| Workbench View | PADER Principal > Latest Version > Malfunction Line Listing | A line listing report for Cases that include combination products with a device constituent that has malfunctioned. Returns a list of device malfunctions categorized by the FDA report type, initial Case, follow-up Case, Seriousness, Listedness, and expedited reporting. |
| Workbench View | PADER Principal > Latest Version > Malfunction Tabulation | A tabulation report for Cases that include combination products with a device constituent that has malfunctioned. Returns the Adverse Event counts grouped by SOC and PT MedDRA levels and categorized by Seriousness and Listedness. |
| Workbench View | PADER Principal > Latest Version > Non-Expedited Line Listing Summary | Summary counts of non-expedited Cases and Submissions broken down by Initial/Follow-up. |
| Workbench View | PADER Principal > Latest Version > Summary for Combination Products | A summary report for Cases that include combination products with a device constituent that has malfunctioned. Returns a count of Case versions and submissions categorized by initial and follow-up Case. |
| Workbench View | PADER Principal > Latest Version > 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. |
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1. To identify Cases submitted under another New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA), Vault looks at whether the Reportable Product Registration on the Transmission matches a Product Registration on the respective Aggregate Reporting Group. If a match does not exist, Vault includes the Case in the Cases Submitted under other NDA's report.
Note: If the Reportable Product Registration and Reportable Product fields are not on the Transmission, your Admin must add these fields to the layout. |
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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.
Note: There is a limitation for creating Aggregate Reporting Groups for PADERs with Combination Products. If the Aggregate Reporting Group includes a registration for a Combination Product and a non-Combination Product, Vault ignores the non-Combination Product registration when generating a PADER.
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
Note: Workbench PADER reports support Aggregate Reporting Groups with either single products or combination products, but not both.
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 Workbench 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 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.