Enable JDrug and WHODrug Cross Reference Tool

Set up and manage the WHODrug Cross Reference Tool (CRT) Japan, which cross-references JDrug and WHODrug codes for case processing and submissions.

About the Feature

With the 24R3 release, Vault Safety now cross-references JDrug and WHODrug codes during case processing using the WHODrug Cross Reference Tool (CRT) Japan. This eliminates manual code entry in the following instances:

  • Adding the applicable WHODrug code when processing a Japan domestic Case with an External Product coded using a JDrug code.
  • Adding the applicable JDrug code when processing a Japan foreign Localized Case with an External Product coded using a WHODrug code.

When new versions of the WHODrug CRT Japan are released, they become available in your Vault. You control which version of the WHODrug CRT Japan Vault uses for coding.

Once configured, Manage the WHODrug Cross Reference Tool (CRT) Japan describes how to maintain the WHODrug CRT Japan version, and Code Japan Drug Dictionary Products and Code WHODrug Products describe how to use this feature.

Prerequisites

Before configuring this feature in your Vault, consider the following:

  • Your organization must maintain a valid WHODrug CRT Japan license.
  • You must contact Veeva Support to add your current WHODrug CRT Japan license for use in Vault Safety.
    • Your WHODrug CRT Japan license will be validated with WHO-UMC. Customers with invalid licenses will not be able to fetch WHODrug CRT Japan release versions.
  • Your Vault must include both a Japan Drug Dictionary and a WHODrug dictionary in the Active state. These dictionaries must have values in the Active JDrug Version and Active WHODrug Version fields respectively.

Configure the Dictionary Object

To configure the Dictionary object, you must create the WHODrug CRT Japan layout, configure the Active Version field, and configure the Fetch Dictionary Releases user action. To complete these procedures, navigate to Admin > Configuration > Objects > Dictionary.

Create the WHODRug CRT Japan Layout

Create an object layout for the Dictionary object:

  1. Navigate to the Layouts tab and select Create.
  2. In the Add Layout window, in the Object Type field, select WHODrug CRT Japan.
  3. Select Done.
  4. On the Dictionary: Record Name page, in the Details section, replace the Active CRT Version field with the Active CRT Version control field with the Slider (app-control) icon.
  5. Optional: Based on your business process, remove any fields from the Details section.
  6. Insert a Detail Form section with the following configuration:
    • Section Label: System Information
    • Fields:
      • Last Modified Date
      • Last Modified By
      • Created Date
      • Created By
  7. Select Save.

Configure the Active Version Field

Complete the following steps to configure the Active Version field to display which version of the WHODrug CRT Japan is active in your Vault:

  1. Navigate to the Fields tab and select Active Version.
  2. Select Edit.
  3. Edit the Formula Expression to match the following:
    if(not(IsBlank(active_meddra_version__c)), text(active_meddra_version__c), if(not(IsBlank(active_imdrf_version__c)), text(active_imdrf_version__c), if(not(IsBlank(active_whodrug_version__c)), text(active_whodrug_version__c), if(not(IsBlank(active_jdrug_version__c)), text(active_jdrug_version__c), if(not(IsBlank(active_crt_version__c)), text(active_crt_version__c), '')))))
  4. Select Save. If an Alert message appears, select OK.

Configure the Fetch Dictionary Releases Action

Add the Fetch Dictionary Releases user action to the WHODrug CRT Japan object type on the Dictionary object.

Update the Case Product Layout

Add the External Product Coding Status field to the Case Product object layout for External Products on Cases:

  1. Navigate to Admin > Configuration > Objects > Case Product > Layouts > External Product Page Layout.
  2. In the Details section, add the External Product Coding Status picklist field.
  3. (Recommended) Move the External Product Coding Status field below the WHODrug field.
  4. Select Save.

Configure the Localized Case Product Object

To configure the Localized Case Product object, update the layout and add a layout rule. To complete these procedures, navigate to Admin > Configuration > Objects > Localized Case Product > Layouts > Localized Case Product Detail Page Layout.

Update the Localized Case Product Layout

Add the External Product Coding Status field:

  1. In the Details section, add the External Product Coding Status field.
  2. (Recommended) Move the External Product Coding Status field below the JDrug field.
  3. Select Save.

Create a Layout Rule for the External Product Coding Status Field

Create a layout rule so the External Product Coding Status field is available only for Localized Cases reportable to Japan:

  1. Select Layout Rules.
  2. On the Layout Rules list page, select Create.
  3. Add a Layout Rule with the following configuration:
    • Label: Hide External Product Coding Status
    • IF this Layout Rule Expression is TRUE: localization__cr.name__v!='Japanese'
    • Apply the following display effects: Hide > Fields > External Product Coding Status
  4. Select Save.

Configure the WHODrug CRT Japan Dictionary

To configure the Dictionary object, you must add the WHODrug CRT Japan dictionary and configure the active version. To complete these procedures, navigate to Business Admin > Objects > Dictionaries.

Add the WHODrug CRT Japan Dictionary

Complete the following steps to add the WHODrug CRT Japan dictionary to your Vault:

  1. On the Dictionaries page, select Create.
  2. From the Select Dictionary Type picklist, select WHODrug CRT Japan and then select Continue.
  3. On the Create WHODrug CRT Japan page, in the Name field, enter a name for the dictionary. We recommend WHODrug CRT Japan.
  4. Select Save.

Update the Active CRT Version

When first adding the WHODrug CRT Japan, you must update the active version.

  1. On the Dictionaries page, select the WHODrug Japan CRT dictionary you added in the previous procedure.
  2. From the All Actions menu, select Fetch Dictionary Releases.
  3. Select Edit.
  4. In the Active CRT Version field, select the desired WHODrug CRT Japan version from the picklist.
  5. Select Save.

Result

Vault imports the selected WHODrug CRT Japan version. When the import is complete, Vault provides system and email notifications. When the dictionary status becomes Active, Vault cross-references WHODrug and JDrug codes using that WHODrug CRT Japan version.