Learn how to configure your Vault to add MedDRA terms and queries directly on a Safety Investigation record.

About the Feature

With the 24R3 release, users can add MedDRA Terms and MedDRA Queries directly on a Safety Investigation.

After you have configured this feature, see Signal Management for more information.

Update the Safety Investigation Layout

To add the Safety Investigation MedDRA Event related object section to the Safety Investigation object:

  1. Navigate to Admin > Configuration > Objects > Safety Investigation > Layouts > Safety Investigation Detail Page Layout.
  2. Under the Details section, insert the Safety Investigation MedDRA Event related object section.
  3. In the Add Related Object Section window, complete the following information:
    • Section Name: Select MedDRA Events.
    • Creation Option: Select Create record in pop-up dialog.
  4. Select Done.
  5. Select Save.

Update Permission Sets

To grant permissions to the Safety Investigation MedDRA Event object:

  1. Navigate to Admin > Users & Groups > Permission Sets > [Permission Set].
  2. Select the Objects tab.
  3. Select Edit.
  4. For the Safety Investigation MedDRA Event object, grant Read, Create, Edit, and Delete permissions.
  5. Select Save.