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.

Configure Dictionary Bulk Actions

To enable MedDRA Bulk Recoding, the Preview Bulk Recode and Run Bulk Recode actions must be added to the Dictionary Bulk Action Object.

  1. In the Admin area, go to Configuration > Objects > Dictionary Bulk Action > Actions.
  2. Add both the Preview Bulk Recode and Run Bulk Recode actions.
    Add MedDRA Bulk Recode Dictionary Bulk 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. Enable MedDRA Bulk Recode User Actions on Dictionary Bulk Action Lifecycle State

Add and Configure the Dictionary Bulk Action Layout

  1. In the Admin area, go to 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 rearrange sections, drag and drop.
  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. In the Admin area, go to Configuration > Objects > Dictionary Bulk Action > Layouts.
  2. Open the Dictionary Bulk Action Detail Page Layout for editing, and then 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:
    • From the Type picklist, select Fields.
    • From the Values picklist, select Study and Study Type.
  5. Under IF this Layout Rule Expression is TRUE, add the following expression:
    report_type__vr.name__v != 'Study' Hide Study and Study Type Fields for Non-Study Cases
  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. In the Admin area, go to 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.

Filter the Study Type Picklist Based on the Organization and Study

Update the MedDRA Dictionary Layout for Dictionary Bulk Recode

  1. In the Admin area, go to Configuration > Objects > Dictionary > Layouts.
  2. Open the MedDRA Detail Page Layout for editing.
  3. Insert the Dictionary Bulk Action related object section. To rearrange sections, drag and drop.
  4. In the Dictionary Bulk Action section, select Edit Columns, and then add the Bulk Action Status and Replacement MedDRA Version columns.
  5. Select Save.

MedDRA Dictionary Layout for Dictionary Bulk Actions