Learn how to update your Vault’s configuration to enable the MedDRA auto-code feature.

About the Feature

MedDRA auto-coding was added in Vault Safety 20R1. Upgraded Vaults must perform the following configuration changes to enable this feature.

To support MedDRA auto-coding, this feature adds a new combined MedDRA control to replace the previously separate reported term and MedDRA term fields. You must add this field to layouts to enable this feature.

The new control allows users to automatically code MedDRA terms using the reported term. The following image shows the combined MedDRA control before entering a term:

MedDRA Combined Field

The following image shows the MedDRA control after auto-coding a term:

Automatically Coded MedDRA Term

Code MedDRA Terms provides more information about coding with the MedDRA dictionary.

Add the MedDRA Control to Layouts

To configure object layouts, go to Configuration > Objects, and then on the appropriate object, open the Layouts tab.

Object Layouts Change
Case Product
  • Biologic Page Layout
  • Device Detail Page Layout
  • Drug Page Layout
  • External Product Page Layout
  • Study Product Page Layout

To enable the auto-code control for Case Product Indications, you must add the Indications section control to Case Product layouts.

Enable Case Product Section Controls provides instructions.

Case Adverse Event Case Adverse Event Detail Page Layout
  • Remove the Event (Reported) and Event (MedDRA) fields
  • Add the MedDRA control
Case Test Result Case Test Result Detail Page Layout
  • Remove the Name (Reported) and Name (MedDRA) fields
  • Add the MedDRA control
Case Medical History Case Medical History Detail Page Layout
  • Remove the Name (Reported) and Name (MedDRA) fields
  • Add the MedDRA control
Case Cause of Death
  • Reported Cause of Death Page Layout,
  • Autopsy Cause of Death Page Layout
  • Remove the Name (Reported) and Name (MedDRA) fields
  • Add the MedDRA control

The following image shows the MedDRA control added to a layout:

MedDRA Auto-Code Control