Learn how to configure your Vault to code Product-Event Combinations to MedDRA queries.
About the Feature
Vault SafetyDocs now offers greater flexibility in Signal Management by allowing you to code Product-Event Combinations to Standard MedDRA Queries (SMQ) and Custom MedDRA Queries (CMQ). For more information, see Signal Management and Enable Signal Management.
Support for this feature was added in 24R2, which includes the necessary configuration by default. Vaults deployed before 24R2 must have the configuration upgrades described on this page to enable this feature.
Configure Layouts
Layouts are managed through Admin > Configuration > Objects > [Object] > Layouts.
Product-Event Combination Layout
Complete the following steps to update this layout:
- On the Product-Event Combination object, go to Layouts > Product-Event Combination Detail Page Layout.
- In the Details section, add the MedDRA Query field.
- In the System section, delete the Primary MedDRA term field.
- Select Save.
Note: As described above, delete the Primary MedDRA term field from the layout but leave the Primary MedDRA Term control field with the Slider (
) icon as is. This ensures that when creating a Product-Event Combination, users can select either a MedDRA term or a MedDRA query.
PEC Period Layout
Complete the following steps to update this layout:
- On the PEC Period object, go to Layouts > PEC Period Detail Page Layout.
- In the Details section, select Add and add the MedDRA Query field.
- Select Save.