Enable MedDRA Synonyms

Veeva Safety can capture company-specific MedDRA coding preferences and speed up coding using MedDRA Synonyms. You can manually create and edit synonyms in your Vault, or bulk import synonyms from an external source.

To use this feature, your Vault must have the configuration described on this page. Vaults deployed in 21R3 or later have the configuration required for this feature by default.

23R1 Update: MedDRA Suggestions

With the 23R1 release, Safety introduces MedDRA Suggestions, an automated feature that improves the speed and efficiency of coding MedDRA terms that aren’t an exact match to the active central MedDRA dictionary or MedDRA Synonym list. With MedDRA Suggestions, when a reported term is matched to a MedDRA code, Vault automatically adds the term to your MedDRA Synonym candidates list, resulting in more consistent MedDRA coding over time.

We recommend enabling MedDRA Suggestions.

Configure the MedDRA Synonym Object Layout

To configure the MedDRA Synonym Detail Page Layout object layout:

  1. To add the Synonym section:
    1. Specify the following section settings:
      • Section Type: Select Detail Form
      • Section Label: Enter Synonym
      • Section Layout: Select Detail Form - One Column
    2. Move the Synonym section to the top of the layout, above the Details section.
    3. Add the MedDRA Reference control field with the Slider (slider icon) icon.
    4. Drag the Verbatim field from the Details section into the Synonym section.
  2. To update the Details section:
    1. Edit the following section settings:
      • Section Label: Enter System
      • Section Layout: Select Detail Form - Two Columns
    2. Remove the following fields:
      • Name
      • Status
      • Lifecycle
      • Lifecycle State

Update the MedDRA Object Layout

To update the MedDRA Detail Page Layout object layout on the MedDRA object, add a related object section as follows:

  • Related Object: Select MedDRA Synonym
  • Section Label: Enter MedDRA Synonyms
  • Columns: Select the following:
    • Name
    • Verbatim

Grant Permissions

Ensure your permission sets are granted the appropriate level of access to objects and fields according to your organization’s process:

  • To allow Admins to manage MedDRA Synonyms, update the Administration Actions permission set to grant the following object permissions to the MedDRA Synonym object:
    • Read
    • Create
    • Edit
    • Delete
  • To allow users to generate MedDRA Synonyms, update the Case Entry Actions permission set to grant Edit field permissions to the MedDRA Synonym Session Store ID field on the following objects:
    • Case Adverse Event
    • Case Cause of Death
    • Case Diagnosis
    • Case Drug History
    • Case Medical History
    • Case Test Result