Enable Postmarket Studies

Learn how to update your Vault’s configuration to support postmarket studies for PADER, PBRER, PSUR, CIOMS I, and FDA MedWatch 3500A reports.

About the Feature

Vault Safety supports postmarket studies for PADER, PBRER, PSUR, CIOMS I, and FDA MedWatch 3500A reports.

(Optional) Relabel Product Usage Reason Field to Study Type

We recommend relabeling the Product Usage Reason field to Study Type. To do this:

1. Navigate to Admin > Configuration > Objects > Case > Fields > Product Usage Reason.
2. Select Edit.
3. Update the Label to Study Type.
4. Select Save.

Update the Study Object

To map the Study Type field from Studies to Cases:

1. Navigate to Admin > Configuration > Objects > Study > Layouts > Study Details Page Layout.
2. Select Edit.
3. In the Details section, add the Study Type field below the Study Number field.
4. Select Save.

To report study case ICSRs in E2B format, we recommend making the Study Type field on the Study object required.