Enable MedDRA Query Building Blocks

Learn how to configure your Vault to use MedDRA Query Building Blocks.

Last Updated

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About the Feature

Vault Safety introduces MedDRA Query Building Blocks as a more efficient way to meet your organization’s adverse event monitoring needs. Building Blocks are reusable queries that combine Standard MedDRA Queries (SMQs), Custom MedDRA Queries (CMQs), and MedDRA Terms at any level of the hierarchy. Once configured, you can apply a single building block to multiple Datasheets and Watchlists. If a Building Block is updated, a single action applies the changes to any Datasheet or Watchlist using it. This automation reduces the administrative burden of maintaining large groups of products with the same adverse event lists, whether for Expectedness evaluations or Watchlist monitoring.

This feature offers an alternative to manually maintaining individual MedDRA Terms on each Datasheet and Watchlist. Using Building Blocks also reduces the need to use Vault Loader for maintenance, saving you extra effort and time.

After configuring this feature, see Manage Datasheets and Auto-Expectedness: Configure Datasheets, Configure Adverse Event Watchlists: Set Up a Watchlist, and Use MedDRA Queries for more information.

Update the Datasheet MedDRA Query Page Layout

Complete the following steps to configure the page layout of the Datasheet MedDRA Query object:

  1. Go to Admin > Configuration > Objects > Datasheet MedDRA Query > Page Layouts > Datasheet MedDRA Query Detail Page Layout.
  2. In the Details section, we recommend updating the list of fields to the following:
    • Datasheet
    • MedDRA Query
    • Scope
    • Expectedness
    • Seriousness Exclusion
    • Active Date Start
    • Active Date End
    • Description
  3. Select Add Section, and then create a Detail Form as follows:
    • Section Label: System
    • Section Layout: Detail Form - Two Columns
  4. In the System section, add the following fields:
    • Created By
    • Created Date
    • Last Modified By
    • Last Modified Date
  5. Select Save.

Update the Datasheet Object and Object Lifecycle

Apply the following changes to the Datasheet object and Datasheet Lifecycle object lifecycle:

  • Add the Datasheet MedDRA Query related object to the page layout
  • Add the Update from MedDRA Queries user action
  • Update the Datasheet Lifecycle object lifecycle

Update the Datasheet Page Layout

Complete the following steps to add the Datasheet MedDRA Query related object to the Datasheet object:

  1. Go to Admin > Configuration > Objects > Datasheet > Page Layouts > Datasheet Detail Page Layout.
  2. Select Add Section, and then add the Datasheet MedDRA Query related object section, including the following setting:
    • In the Creation Option section, select Create record in pop-up dialog.
  3. In the Datasheet MedDRA Queries section, select Edit Default Columns to update the list of columns to the following:
    • MedDRA Query
    • Scope
    • Expectedness
    • Seriousness Exclusion
    • Active Date Start
    • Active Date End
    • Description
  4. Drag and drop to move the Datasheet MedDRA Queries section below the Expected/Unexpected Event Terms section.
  5. Select Save.

Add the Update from MedDRA Queries User Action

Complete the following steps to add the Update from MedDRA Queries user action to the Datasheet object:

  1. Go to Admin > Configuration > Objects > Datasheet > Actions.
  2. Select Create.
  3. In the Create Action dialog, select Update from MedDRA Queries and then select Continue.
  4. Select Save.

Update the Datasheet Lifecycle Object Lifecycle

Complete the following steps to add the Update from MedDRA Queries action to the Datasheet Lifecycle object lifecycle:

  1. Go to Admin > Configuration > Object Lifecycles > Datasheet Lifecycle.
  2. In the States section, select Active.
  3. In the User Actions section, select Edit.
  4. On the User Actions page, select Create Rule with the following settings:
    • Always
    • Allow the following actions: Update from MedDRA Queries
    • Action Label: Update from MedDRA Queries
  5. Select Save.

Update the Watchlist MedDRA Query Page Layout

Complete the following steps to configure the page layout of the Watchlist MedDRA Query object:

  1. Go to Admin > Configuration > Objects > Watchlist MedDRA Query > Page Layouts > Watchlist MedDRA Query Detail Page Layout.
  2. In the Details section, we recommend updating the list of fields to the following:
    • Watchlist
    • MedDRA Query
    • Scope
  3. Select Add Section, and then create a Detail Form as follows:
    • Section Label: System
    • Section Layout: Detail Form - Two Columns
  4. In the System section, add the following fields:
    • Created By
    • Created Date
    • Last Modified By
    • Last Modified Date
  5. Select Save.

Update the Watchlist Object and Object Lifecycle

Apply the following changes to the Watchlist object and Watchlist Lifecycle object lifecycle:

  • Add the Watchlist MedDRA Query related object to the page layout
  • Add the Update from MedDRA Queries user action
  • Update the Watchlist Lifecycle object lifecycle

Update the Watchlist Page Layout

Complete the following steps to add the Watchlist MedDRA Query related object to the Watchlist object:

  1. Go to Admin > Configuration > Objects > Watchlist > Page Layouts > Watchlist Detail Page Layout.
  2. Select Add Section, and then add the Watchlist MedDRA Query related object section, including the following setting:
    • In the Creation Option section, select Create record in pop-up dialog.
  3. In the Watchlist MedDRA Queries section, select Edit Default Columns to update the list of columns to the following:
    • MedDRA Query
    • Scope
  4. Drag and drop to move the Watchlist MedDRA Queries section below the MedDRA Terms section.
  5. Select Save.

Add the Update from MedDRA Queries User Action

Complete the following steps to add the Update from MedDRA Queries user action to the Watchlist object:

  1. Go to Admin > Configuration > Objects > Watchlist > Actions.
  2. Select Create.
  3. In the Create Action dialog, select Update from MedDRA Queries and then select Continue.
  4. Select Save.

Update the Watchlist Lifecycle Object Lifecycle

Complete the following steps to add the Update from MedDRA Queries action to the Watchlist Lifecycle object lifecycle:

  1. Go to Admin > Configuration > Object Lifecycles > Watchlist Lifecycle.
  2. In the States section, select Active.
  3. In the User Actions section, select Edit.
  4. On the User Actions page, select Create Rule with the following settings:
    • Always
    • Allow the following actions: Update from MedDRA Queries
    • Action Label: Update from MedDRA Queries
  5. Select Save.

Update the MedDRA Query Object and Object Lifecycle

Apply the following changes to the MedDRA Query object and MedDRA Query Lifecycle object lifecycle:

  • Update the MedDRA Query page layout so that it includes the MedDRA Query Building Blocks, Datasheet MedDRA Queries, and Watchlist MedDRA Queries related objects
  • Update the Layout Rules to hide sections based on settings
  • Add the Update Datasheet and Watchlist Terms user action
  • Update the MedDRA Query Lifecycle object lifecycle

Update the MedDRA Query Page Layout

Complete the following steps to add the MedDRA Query Building Blocks, Datasheet MedDRA Queries, and Watchlist MedDRA Queries related objects to the MedDRA Query object:

  1. Go to Admin > Configuration > Objects > MedDRA Query > Layouts > MedDRA Query Detail Page Layout.
  2. In the Details section, add the MedDRA Query Type field.
  3. Select Add Section, and then add the MedDRA Query Building Blocks related object section.
  4. Repeat step 2 to add the Datasheet MedDRA Queries and Watchlist MedDRA Queries related object sections.
  5. Drag and drop so that the sections appear in the following order:
    • Details
    • MedDRA Terms
    • MedDRA Query Building Blocks
    • Datasheet MedDRA Queries
    • Watchlist MedDRA Queries
    • Sub-Queries
    • Workflow Timeline
  6. Select Save.

Update the Layout Rules

Complete the following steps to hide the MedDRA Query Building Blocks, Datasheet MedDRA Queries, and Watchlist MedDRA Queries sections on MedDRA Query records based on settings.

Go to Admin > Configuration > Objects > MedDRA Query > Layouts > MedDRA Query Detail Page Layout to configure Layout Rules.

Hide When Hierarchical Is Set to No

Complete the following steps to hide the sections when the Hierarchical field is set to No:

  1. On the MedDRA Query Detail Page Layout page, select Layout Rules and then Hierarchical.
  2. Select Edit and update the Layout Rule with the following details:
    • IF this Layout Expression is TRUE: hierarchical__v
    • Apply the following display effects:
      • Effect: Hide
      • Type: Sections
      • Values: MedDRA Terms
  3. Select Save.

Hide When MedDRA Query Type is Not Set to No

Complete the following steps to hide the sections when the MedDRA Query Type field is not set to No:

  1. On the MedDRA Query Detail Page Layout page, select Layout Rules and then Create.
  2. Complete the Create Layout Rule form with the following details:
    • Label: Not Building Blocks
    • Name: not_building_blocks__c
    • IF this Layout Expression is TRUE: meddra_query_type__v != "building_block__v" || hierarchical__v
    • Apply the following display effects:
      • Effect: Hide
      • Type: Sections
      • Values: MedDRA Query Building Blocks, Datasheet MedDRA Queries, Watchlist MedDRA Queries
  3. Select Save.

Add the Update Datasheet and Watchlist Terms User Action

Complete the following steps to add the Update Datasheet and Watchlist Terms user action to the MedDRA Query object:

  1. Go to Admin > Configuration > Objects > MedDRA Query > Actions.
  2. Select Create.
  3. In the Create Action dialog, select Update Datasheet and Watchlist Terms and then select Continue.
  4. Select Save.

Update the MedDRA Query Lifecycle Object Lifecycle

Complete the following steps to add the Update Datasheet and Watchlist Terms action to the MedDRA Query Lifecycle object lifecycle:

  1. Go to Admin > Configuration > Object Lifecycles > MedDRA Query Lifecycle.
  2. In the States section, select Active.
  3. In the User Actions section, select Edit.
  4. On the User Actions page, select Create Rule with the following settings:
    • Always
    • Allow the following actions: Update Datasheet and Watchlist Terms
    • Action Label: Update Datasheet and Watchlist Terms
  5. Select Save.

Update the MedDRA Query Building Block Object

Complete the procedures in this section to update the page layout of the MedDRA Query Building Block object and add a VQL constraint to the MedDRA Query field.

Go to Admin > Configuration > Objects > MedDRA Query Building Block to make the changes.

Update the MedDRA Query Building Block Page Layout

Complete the following steps to update the page layout of the MedDRA Query Building Block object:

  1. On the Page Layouts tab, select MedDRA Query Building Block Detail Page Layout.
  2. In the Details section, we recommend updating the list of fields to the following:
    • CMQ
    • MedDRA Query
    • Scope
  3. Select Add Section, and then create a Detail Form as follows:
    • Section Label: System
    • Section Layout: Detail Form - Two Columns
  4. In the System section, add the following fields:
    • Created By
    • Created Date
    • Last Modified By
    • Last Modified Date
  5. Select Save.

Add a VQL Constraint to the MedDRA Query Field

To ensure only SMQs and CMQs can be added to a MedDRA Query Building Block, add the following VQL constraint to the MedDRA Query field:

  1. On the Fields tab, select MedDRA Query.
  2. Select Edit.
  3. In the Criteria VQL field, enter meddra_query_type__v != 'building_block__v'.
  4. Select Save.