Enable Multilingual MedDRA

Learn how to update your Vault’s configuration to enable Multilingual MedDRA.

About the Feature

With the 20R3 release, Safety supports multiple languages in Central MedDRA. After you have enabled this feature, see the following articles for more information:

• Manage the MedDRA Dictionary
• Code MedDRA Terms

21R2 Updates: Multilingual MedDRA Browser

With the 21R2 release, Safety added the ability to code and auto-code Adverse Events in any non-English MedDRA supported languages. Users can use the multilingual browser on Inbox Items during intake and Case Adverse Events during subsequent case processing. See the following sections to enable your Vault for the updated feature:

• Multilingual MedDRA Browser & Autocode
• Multilingual MedDRA: Japanese

Grant Object Permissions

Ensure your permission sets are updated to grant the appropriate level of access for users to objects and fields according to your organization’s process. Manage object permissions from Admin > Users & Groups > Permission Sets > [Permission Set] > Objects > MedDRA (Localized). Add Read permission to the following permission sets:

• Administration Actions
• Case Distribution Actions
• Case Entry Actions
• Case Intake Actions
• Case Review Actions
• Safety Operations Actions
• Safety Writer
• Submission Actions

Select a MedDRA Language

To select a MedDRA language:

1. Ensure that your Vault is set up to use the Centralized MedDRA Dictionary.
2. Navigate to Business Admin > Dictionaries > MedDRA Dictionary.
3. Select Edit.
4. In the Languages field, select the language you want to use.
5. Select Save.

(21R2) Multilingual MedDRA: Japanese

To enable multilingual MedDRA for Japanese, select Japanese in the Language field for the MedDRA Dictionary. This enables Japanese MedDRA on a Case but is not needed to enable Japanese MedDRA for Inbox Items.

(21R2) Multilingual MedDRA Browser & Autocode

Complete the procedures in this section to enable the multilingual MedDRA Browser.

Update the MedDRA Layout

Update the MedDRA object layout to include the Enable Multilingual MedDRA Browser field in the Details section.

Create a Layout Rule

Create a layout rule to hide the Enable Multilingual MedDRA Browser field for local MedDRA:

1. Navigate to Admin > Configuration > Objects > Dictionary > Layouts > Dictionary Detail Page Layout > Layout Rules > Local Dictionary.
2. Select Edit.
3. In the Hide the following Page Layout Items section, for Values, add Enable Multilingual MedDRA Control.
4. Select Save.

Update the Case Adverse Event Layout

Update the Case Adverse Event object layout:

1. Navigate to Admin > Configuration > Objects > Case Adverse Event > Layouts > Case Adverse Event Detail Page Layout.
2. Select Edit.
3. In the Details section, remove the Event (Reported) - Language and Event (Reported) - English fields.
4. Select Save.