Enable Support for MedDRA Queries in Submission Rules

Learn how to update your Vault to enable extended support for submission rules in MedDRA queries.

About the Feature

MedDRA Queries (SMQs and CMQs) can be used to determine if a case should be reportable in order to support situations such as “Lack of Efficacy” or customer-managed lists of non-reportable terms.

Vaults created in 22R1 or later include the necessary configuration by default, while Vaults originally deployed earlier than 22R1 must have the configuration upgrades described on this page to enable this feature.

Update the MedDRA Query Layout

You must update the MedDRA Query layout with the following configurations to enable the feature.

Add the API Name Field

1. In Admin, go to Configuration > Objects > MedDRA Query.
2. On the Layouts tab, open the MedDRA Query layout.
3. Select Add from the System Information section.
4. Select API Name.
5. Select Save.

Add the Submission Rule Scope Field

1. Select Add from the System Information section.
2. Select Submission Rule Scope.
3. Select Save.

Update the Root Query Layout Rule

1. On the MedDRA Query layout, select Layout Rules.
2. Select Root Query.
3. Select .
4. In the Hide the following Page Layout Items section, add the following fields:
   • API Name
   • Submission Rule Scope
5. Select Save.

Add the API Name Field to the Study Layout

1. In Admin, go to Configuration > Objects > Study.
2. In the Layouts tab, open the Study layout.
3. Move the API Name field to the System Information section.
4. Select Save.

Add the API Name Field to Product Layouts

You must add the API Name field to the following Product-type layouts:

• Biologic Page Layout
• Combination Product Page Layout
• Device Detail Page Layout
• Drug Page Layout
• Vaccine Detail Page Layout

1. In Admin, go to Configuration > Objects > Product.
2. On the Layouts tab, open a [Product] layout.
3. Select Add from the System Information section.
4. Select API Name.
5. Select Save.