Learn about PADER aggregate reports in Safety Workbench and how to generate them.
About Workbench PADERs
Vault Safety Workbench provides U.S. Periodic Adverse Drug Experience Report (PADER) authoring and table generation capabilities.
The following table summarizes the PADER tabulations that Safety Workbench generates:
| Tabulation | Description |
|---|---|
| 15 Day and Non-15 Day Summary Reports | This report prints the number of Case Adverse Events that match report criteria. Vault generates tables for both initial reports and follow-up reports. |
| Summary of ADR from Postmarketing Sources | This report prints the number of Case Adverse Events that match report criteria. |
| Interval Line Listings | This report prints the Case listing that matches report criteria. Vault categorizes Case listings by initial and follow-up reports, seriousness, listedness, and whether the report was expedited. |
| Malfunction Line Listing | For Cases that contain combination products with a Device product type that has malfunctioned, this report prints a listing of device constituent malfunctions. |
| Line Listing Summary for Combination Products | This report is a summary listing of Cases that contain combination products with a Device product type that has malfunctioned. |
| Malfunction Tabulation | For Cases that contain combination products with a Device product type that has malfunctioned, this report prints the number of Case Adverse Events that match report criteria. |
| Cases Submitted under other NDA's | This report prints the Case listing that matches report criteria.
This report is a summary listing of the Adverse Events in which the drug or biological Product was listed as one (1) of the suspect Products, but the report was filed to another New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA) held by the applicant. |
You can also include nullified and voided Cases in Workbench PADER aggregate reports.
Safety Workbench allows you to generate, run, and download multiple Workbench aggregate reports at once. If this option is relevant to your organization’s business processes, see Manage Workbench Report Sets.
Combination Products on Workbench PADERs
Workbench PADERs include Cases with combination products. If the combination product contains a device constituent that has malfunctioned and the combination product is in the Aggregate Reporting Group and on the FDA Transmission, the Case is eligible for the following PADERs:
- Malfunction Line Listing
- Line Listing Summary for Combination Products
- Malfunction Tabulation
See Manage Combination Products for more information about combination products and their constituents.
How Vault Determines Expectedness
Vault sets the Expectedness field on a Case. To determine whether an Adverse Event is expected for combination products with a device constituent, Vault looks at the non-device constituent and finds all Expectedness records on Case Assessments that meet the following criteria:
- Is attached to a Registration record of a combination product.
- Lists a country that is supported by the FDA.
- Has a datasheet registration that matches the registration in the Aggregate Reporting Group.
If at least one (1) record has the Expected field set to No or blank, Vault determines an Adverse Event is unexpected.
How Vault Determines Listedness
Vault sets the Listedness field on a Case. For combination products with a device constituent, Vault determines an Adverse Event is listed if the non-device constituent in the Aggregate Reporting Group is associated with an unexpected Adverse Event.
Cases Under Other NDAs on Workbench PADERs
If at least one (1) reportable Product Registration on the FDA Transmission for the Case matches that of the Aggregate Reporting Group, Vault includes this Case in one (1) of the following reports:
- 15 Day and Non-15 Day Summary Reports
- Summary of ADR from Postmarketing Sources
- Interval Line Listings
If the reportable Product Registration on the FDA Transmission for the Case does not match that of an Aggregate Reporting Group, Vault includes the Case in the Cases Submitted under other NDA’s report. For more information about how Vault identifies Cases as submitted under another NDA, ANDA, or BLA, see Configure Workbench PADER Aggregate Reports.
Prerequisites
To generate Workbench PADERs, you must contact Veeva Support and your Admin must configure Workbench PADER aggregate reports.
Create a Workbench PADER
To create a Workbench PADER:
- Navigate to Workbench > Ad-Hoc Reports.
- Select Create.
- Complete the following information:
- Name: Enter a name for this report.
- Workbench View: Select a PADER view from the drop-down or use the Advanced Search (
) icon to use filters and refine your search.
- Set up Workbench Report filters, layout, and advanced options (standard templates) as needed.
For PADERs, you must set a value for the Aggregate Reporting Group filter to define the Product Registrations and Study Registrations that will be included on the Workbench aggregate report. For more information about Aggregate Reporting Groups, contact your Admin. - Select Save.
- Run and download the PADER.
Note: For the PADER Summary of ADR from Postmarketing Sources report output, if a Case has multiple LLT Adverse Events that fall under the same PT, Vault counts the PT only once.