Enable the Japan Drug Dictionary

Set up and manage the Japan Drug Dictionary (JDD) for maintenance, Case processing, and Submissions.

About the Feature

Vault Safety now supports the Japan Drug Dictionary (JDD), which is available when processing Domestic and Localized Cases for Japan. This capability includes looking up and coding External Products and Substances with JDrug codes. For Company Products in your Product library, the system continues to snapshot codes from the Local Product Code field of Japan Product Registration records.

When new versions of the JDD are released, they are made available in your Vault. You control which version of the JDD the system uses for coding.

Once enabled, Manage the Japan Drug Dictionary describes how to maintain the dictionary and Code Japan Drug Dictionary Products describes how to use this feature.

Prerequisite

Your organization must maintain a valid JDD license to use the centralized JDD service.

Add the Japan Drug Dictionary (JDD) Layout

Complete the following steps to add the JDrug Dictionary layout to your Vault:

  1. Go to Admin > Configuration > Objects > Dictionary > Layouts.
  2. Select Create.
  3. On the Add Layout page, select JDrug Dictionary from the picklist, and then select Create.
  4. On the Dictionary: Record Name page, in the Details section, replace the Active JDrug Version field with the App Control Active JDrug Version field.
  5. Insert a Detail Form section with the Section Label “System Information”.
  6. In the System Information section that you just created, add the following fields:
    • Last Modified Date
    • Last Modified By
    • Created Date
    • Created By
  7. Select Save.

Configure the Active Version Field on the JDD

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

  1. Go to Admin > Configuration > Objects > Dictionary > Fields.
  2. In the Field column, select Active Version, and then select Edit.
  3. Edit the Formula Expression to match the following:
    if(not(IsBlank(active_meddra_version__v)), text(active_meddra_version__v), if(not(IsBlank(active_imdrf_version__v)), text(active_imdrf_version__v), if(not(IsBlank(active_whodrug_version__v)), text(active_whodrug_version__v), if(not(IsBlank(active_jdrug_version__v)), text(active_jdrug_version__v), ''))))
  4. Select Save. If an Alert message appears, select OK.

Enable Fetch Dictionary Releases for the JDrug Dictionary

Complete the following steps to enable the Fetch Dictionary Releases user action on the JDrug Dictionary object type:

  1. Go to Admin > Configuration > Objects > Dictionary > Object Types.
  2. On the right side of the page, toggle to Actions.
  3. In the All Actions menu, select Edit Object Type Actions.
  4. In the JDrug Dictionary column, select the Fetch Dictionary Releases checkbox.
  5. Select Save.

Configure the Case Product Layout for Adding JDrug Codes to External Products

Complete the following steps to configure the JDrug field on External Products for Cases that are reportable to Japan:

  1. Go to Admin > Configuration > Objects > Case Product > Layouts > External Product Page Layout.
  2. (Recommended) Move the Country Obtained field below the Drug Role field.
  3. In the Details section, add the App ControlJDrug field. (Recommended) Move this field below the Product (Reported) field.
  4. Select Save.

Configure the Localized Case Product Layout

Go to Admin > Configuration > Objects > Localized Case Product to complete the following configurations to support JDD coding on Localized Cases reportable to Japan.

  1. Create a Lookup field for Case Product Type.
  2. Update the layout.
  3. Create a Layout Rule.

Create a Lookup Field for Case Product Type

Complete the following steps to create a Lookup Field for Case Product Type:

  1. On the Fields tab, select Create.
  2. Complete the Create Field form with the following information:
    • Field Type: Lookup
    • Label: Case Product Type
    • Name: case_product_type__c
    • Lookup Relationship: Case Product (case_product__vr)
    • Lookup Source Field: Product Type
  3. Select Save. If a system message appears, select Continue.

Update the Layout

Complete the following steps to update the layout:

  1. On the Layouts tab, select Localized Case Product Detail Page Layout.
  2. Move the App Control JDrug field below the Product (Reported) field.
  3. Select Save.

Create a Layout Rule

Complete the following steps to create a Layout Rule so that the JDrug field appears only when coding External Products on a Localized Case that is reportable to Japan.

  1. From the Localized Case Product Detail Page Layout page, select Layout Rules.
  2. Select Create and then configure the fields of the Layout Rule as follows:
    • Label: Enter a label, for example, “Japan External”.
    • Hide the following Page Layout Items:
      • Type: Fields
      • Values: Product (Coded), Registration Holder/Applicant, Local MPID
    • IF this Layout Rule Expression is TRUE:
      (case_product_type__cr.name__v = 'External Product') &&
      (localization__cr.name__v != 'Japanese')
  3. Select Save.

Add the Japan Drug Dictionary (JDD)

Complete the following steps to add the Japan Drug Dictionary (JDD) to your Vault:

  1. Go to Business Admin > Objects > Dictionaries.
  2. On the Dictionaries page, select Create.
  3. In the Create Dictionary window, select JDrug Dictionary from the Select Dictionary Type picklist.
  4. On the Create JDrug Dictionary page, in the Name field enter a name for the dictionary. For example, “JDrug Dictionary”.
  5. Select Save.

Result

The JDD is available in your Vault. Update the active dictionary version to make it ready for coding.

Update the Active JDrug Version

When first adding the JDD, you must update the active dictionary version.

  1. Go to Business Admin > Objects > Dictionaries.
  2. On the Dictionaries page, select the JDrug Dictionary from the table. The JDrug Dictionary page appears.
    • When the list of available JDD versions is out of sync with the server, you see the following notification in the Active JDrug Version field: The list of available JDrug versions is out of sync with the server. Please sync the JDrug versions to update the list.
  3. To sync the list of available JDrug versions, perform the following steps:
    1. Open the All Actions menu.
    2. Select Fetch Dictionary Releases. The system retrieves any new versions.
  4. To activate a JDrug version, perform the following steps:
    1. On the JDrug Dictionary page, select Edit.
    2. In the Active JDRUG Version field, select the desired dictionary version from the picklist.
    3. Select Save.

Result

The system imports the selected version of the JDD. When the import is complete, you receive an email notification.

The status of the JDD becomes Active. When the JDrug Browser is used, the search results are based on the version selected.