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.

Last Updated

Note Beginning with 24R1 in April 2024 and for all subsequent releases, Vault Safety General Release Help content is moving to a new site. Test the new site using Limited Release content.

About the Feature

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

This page describes both required and optional but recommended vault configuration to support this feature.

Tip Vaults originally deployed from the 21R1 release template will have this configuration by default.

(Optional) Relabel Product Usage Reason Field to Study Type

We recommend that you relabel the Product Usage Reason field to Study Type.

  1. In the Admin area, go to Configuration > Objects.
  2. Open the Case (case_version__v) object.
  3. Open the Fields tab.
  4. Select the Product Usage Reason (study_product_reason__v) field.
  5. On the Product Usage Reason page, select Edit.
  6. Change the Label to Study Type.
  7. Select Save.

Add the Study Type Field to the Study Object

To enable the automatic snapshotting of the Study Type (study_type__v) field from Studies in the Business Admin library to Cases, perform the following configuration.

Update the Study Details Page Layout

  1. Go to Configuration > Objects.
  2. Open the Study (study__v) object.
  3. Open the Page Layouts tab.
  4. Select the Study Details Page Layout.
  5. Add the Study Type (study_type__v) field to the page layout. We recommend adding this field to the Details section, below Study Number.
  6. Select Save.

(Optional) Make the Study Type Field Required

If you are reporting study case ICSRs in E2B format, we recommend making the Study Type field required on the Study object:

  1. In Configuration > Objects > Study, open the Fields tab.
  2. Select the Study Type (study_type__v) field.
  3. On the Study Type page, select Edit.
  4. Under Options, select User must always enter a value (required).
  5. Select Save.

(Optional) Move the Study Type Field on the AER Page Layout

We recommend moving the Study Type field for better visibility when users enter the Case Report Type and Study information.

  1. Go to Configuration > Objects.
  2. Open the Case (case_version__v) object.
  3. Open the Page Layouts tab.
  4. Select the AER Detail Page Layout.
  5. Move the Study Type (study_type__v) field to the Details section. For convenience, we recommend placing this field below Study.
  6. Select Save.
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