Enable MedDRA Bulk Recode Cases

Learn how to update your Vault’s configuration to enable the bulk recode feature for Cases.

About the Feature

Vault Safety now supports bulk recoding of MedDRA-coded terms when MedDRA Dictionary updates are released. Using MedDRA Bulk Recode makes the process of updating Cases more efficient and accurate. Changes can be previewed and validated before they are committed, and are tracked in Case audit trails.

Once enabled, for more information about using this feature, see Bulk Recode MedDRA-Coded Terms on Cases for more information.

24R3 Update: MedDRA Bulk Recode Without Case Upversioning

With the 24R3 release, you can configure your Vault so that the Preview Bulk Recode and Run Bulk Recode actions apply to all Case versions, including the latest version. To support this feature, you must add the Dictionary Bulk Action Scope field to the Dictionary Bulk Action object layout.

Configure Dictionary Bulk Actions

To enable MedDRA Bulk Recoding, you must add the Preview Bulk Recode and Run Bulk Recode actions to the Dictionary Bulk Action object.

  1. Go to Admin > Configuration > Objects > Dictionary Bulk Action > Actions.
  2. Add both the Preview Bulk Recode and Run Bulk Recode actions.
  3. (Recommended) Go to Configuration > Object Lifecycles > Dictionary Bulk Action Case Lifecycle > States > Active.
    • Add both the Preview Bulk Recode and Run Bulk Recode actions.

Add and Configure the Dictionary Bulk Action Layout

  1. Go to Admin > Configuration > Objects > Dictionary Bulk Action > Layouts.
  2. Create the Dictionary Bulk Action Detail Page Layout.
  3. Configure the Dictionary Bulk Action Detail Page Layout as shown below.
  4. To support the MedDRA Bulk Recode Without Case Upversioning feature, add the Dictionary Bulk Action Scope field to the Case Inclusion Criteria section.
  5. Select Save.

Dictionary Bulk Action Layout

Optionally, add a layout rule so that the Study and Study Type fields appear only for Study Cases.

  1. Go to Admin > Configuration > Objects > Dictionary Bulk Action > Layouts > Dictionary Bulk Action Detail Page Layout.
  2. Select Layout Rules.
  3. On the Layout Rules page, select Create to add rules with the following details:
    • Label: MedDRA Bulk Recode
    • Name: meddra_bulk_recode
  4. Under Hide the following Page Layout Items:
    • For Type, select Fields.
    • For Values, select Study and Study Type.
  5. Under IF this Layout Rule Expression is TRUE, add the following expression: report_type__vr.name__v != 'Study'
  6. Select Save.

Optionally, add a filter so that the options in the Study Type picklist are based on the Organization and the selection in the Study field.

  1. Go to Admin > Configuration > Objects > Dictionary Bulk Action > Fields > Study.
  2. Select Edit.
  3. In the Constrain Records in Referenced Object section, update the Criteria VQL field to include organization and study type with the following VQL:
    organization__v = {{this.organization__v}} AND study_type__v = {{this.study_type__v}}
  4. Select Save.

Update the MedDRA Dictionary Layout for Dictionary Bulk Recode

  1. Go to Admin > Configuration > Objects > Dictionary > Layouts > MedDRA Detail Page Layout.
  2. Insert the Dictionary Bulk Action related object section.
  3. In the Dictionary Bulk Action section, select Edit Columns, and then add the Bulk Action Status and Replacement MedDRA Version columns.
  4. Select Save.