Learn how to display product or study registration details on Submissions to the FDA.
About the Feature
With the 24R3 release, Vault Safety enhances support for aggregate reports by including the appropriate product registration details used to generate the ICSR Submission. This enhancement allows users to track the registration used when generating ICSR Submission and allows for more accurate aggregate reporting.
Although this feature is Auto-on, you can optionally update object layouts to allow users to see registration-related field values on ICSR Submissions.
After you have configured this feature, see Understand the Reporting Rules Engine for more information.
Update the Transmission Layout
You can add the following fields to the Submission Detail Page Layout of the Transmission object:
- Reportable Product
- Reportable Product Registration
- Reportable Study
- Reportable Study Registration
Update the Transmission Study Layout
You can add the Study Registration field to the Transmission Study object layout.