Enable Adding MedDRA Terms and Queries for Safety Investigations

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. This allows users to capture multiple related adverse events as part of a single investigation.

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

Update the Safety Investigation Layout

Update the Safety Investigation object layout by inserting 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. Before the Summary of Key Data section, insert the Safety Investigation MedDRA Event related object section.
  3. In the Add Related Object Section window, complete the following information:
    • Related Object: From the drop-down, select Safety Investigation MedDRA Event.
    • Section Label: Enter MedDRA Events.
    • Creation Option: Select Create record in pop-up dialog.
  4. Select Done.
  5. Select Save.

Update the Safety Investigation MedDRA Event Object

Update the Safety Investigation MedDRA Event object by replacing the MedDRA Term field with the control field on the Safety Investigation MedDRA Event layout:

  1. Navigate to Admin > Configuration > Objects > Safety Investigation MedDRA Event > Layouts > Safety Investigation MedDRA Event Detail Page Layout.
  2. In the Details section, perform the following:
    • Remove the MedDRA Term field.
    • Add the MedDRA Term control field with the Slider (slider-icon) icon.
  3. Select Save.

Grant Permissions

To grant permissions to the applicable permission sets:

  1. Navigate to Admin > Users & Groups > Permission Sets > [Permission Set].
  2. Select the Objects tab.
  3. Select the Safety Investigation MedDRA Event object.
  4. Beside Object Permissions, select Edit.
  5. For the Safety Investigation MedDRA Event object, grant Read, Create, Edit, and Delete permissions.
  6. Select Save.
  7. Beside Object Control Permissions, select Edit.
  8. For the MedDRA Term object control field, grant View permissions.
  9. Select Save.