Enable Local Fields for PMDA (Japan)

Learn how to update your Vault’s configuration to enable Japanese localization fields.

About the Feature

Support for local fields for PMDA (Japan) was added in 21R1. Vaults created in 21R2 or later include the necessary configuration by default, while Vaults originally deployed earlier than 21R2 must have the configuration upgrades described on this page to enable this feature.

Update the Product Registration Layout

  1. Navigate to Admin > Configuration > Objects > Product Registration.
  2. On the Layouts tab, open the Product Registration Detail Page Layout.
  3. Insert a Detail Form section.
  4. Complete the Add Detail Form form with the following details:
    • Section Label: PMDA
  5. Select Done.
  6. Add the following fields to the PMDA Detail section:
    • Dose Form
    • Japan Product Code Type
    • Clinical Compound Number
    • OTC Drug Classification
  7. Select Add from the Registration Details section.
  8. Select Local Product Code.
  9. Select Save.

Add the E2B Field to the Localized Dose Form Layout

  1. Navigate to Admin > Configuration > Objects > Localized Dose Form.
  2. On the Layouts tab, open the Localized Dose Form Detail Page Layout.
  3. Select Add from the Details section.
  4. Select E2B Code. We recommend placing this field above the Localization field.
  5. Select Save.

Insert the Localized Substance Section on the Substance Layout

  1. Navigate to Admin > Configuration > Objects > Substance.
  2. On the Layouts tab, open the Substance Detail Page Layout.
  3. Insert a Related Object section.
  4. Complete the Add Related Object form with the following details:
    • Related Object: Localized Substance
    • Section Label: Localized Substances
    • Create Option: Create record in new page
    • We recommend placing the Localized Substance section above the Workflow Timeline section.
  5. Select Done.

Add the Development Phase Field to the Study Layout

  1. Navigate to Admin > Configuration > Objects > Study.
  2. On the Layouts tab, open the Study Detail Page Layout.
  3. Select Add from the Details section.
  4. Select Development Phase.
  5. Select Save.

Update the Localized Study Layout

Insert the PMDA Detail Section

  1. Navigate to Admin > Configuration > Objects > Localized Study.
  2. On the Layouts tab, open the Localized Study Detail Page Layout.
  3. Insert a Detail Form section.
  4. Complete the Add Detail Form form with the following details:
    • Section Label: PMDA
  5. Select Done.
  6. Add the following fields to the PMDA Detail section:
    • Target Disease
    • Existence of Subjects
    • Number of Clinical Trial Notifications
  7. Select Save.

Update the Localized Case Layout

Update the Details Section

  1. Select Add from the Details section.
  2. Add the following fields:
    • Local Awareness Date
    • Localized Parent Information
  3. Select Save.

Add the Local MPID Field to the Localized Case Product Layout

  1. Navigate to Admin > Configuration > Objects > Localized Case Product.
  2. On the Layouts tab, open the Localized Case Product Detail Page Layout.
  3. Select Add from the Details section.
  4. Select Local MPID.
  5. Select Save.

Add the Local Product Code Field to the Localized Case Product Substance Layout

  1. Navigate to Admin > Configuration > Objects > Localized Case Product Substance.
  2. On the Layouts tab, open the Localized Case Product Substance Detail Page Layout.
  3. Select Add from the Details section.
  4. Select Local Product Code. We recommend placing this field above the Organization field.
  5. Select Save.

Create the Japan Layout for the Case Product Registration Object

  1. Navigate to Admin > Configuration > Objects > Case Product Registration.
  2. Select Create on the Layouts tab.
  3. Complete the Add Layout form with the following details:
    • Object Type: Japan
    • Layout Label: Japan Detail Page Layout
  4. Select Create.
  5. Configure the Japan Detail Page Layout with the sections and fields/columns as shown in the table below.
  6. Select Save.
Section Settings Fields/Columns
Details
  • Type: Detail Form
  • Section Label: Details
  • Section Name: details__c
  • Section Layout: Detail Form - Two Columns
  • Name
  • Case
  • Localized Case
  • Case Product
  • Product
  • Rank
  • Product Registration
  • Registration Type
  • Registration Country
  • Registration Holder/Applicant
  • Registration Number
  • Dose Form
  • Local Product Code
  • OTC Drug Classification
  • OTC Drug Channel
  • Product (Reported)
Reporting Information
  • Type: Detail Form
  • Section Label: Reporting Information
  • Section Name: reporting_information__c
  • Section Layout: Detail Form - Two Columns
  • PMDA Reporting Category
  • Completeness
  • Immediate Report Type
  • Report Overview
Case Comments
  • Type: Related Object
  • Related Object: Localized Case Comment
  • Section Label: Case Comments
  • Section Name: case_comments__c
  • Name
  • Comments Label
  • Comments Text
  • Case Product Registration

Configure the Case Comments Object

Add the Organization Custom Field

  1. Navigate to Admin > Configuration > Objects > Case Comments.
  2. Select Create on the Fields tab.
  3. Complete the Create Field form with the following information:
    • Field Type: Lookup
    • Label: Organization
    • Lookup Relationship: Case (case__vr)
    • Lookup Source Field: Organization
  4. Select Save.

Update the Case Comments Layout

  1. Navigate to Admin > Configuration > Objects > Case Comments.
  2. On the Layouts tab, open the Case Comments Detail Page Layout.
  3. Configure the Details section fields as follows:
    • Case
    • Localized Case
    • Case Product
    • Case Product Registration
    • Comments Label
    • Comments Text
  4. Select Save.

Security

Update the Case Translation Actions Permission Set

  1. In Admin, go to Users & Groups > Permission Sets.
  2. Select Case Translation Actions.
  3. Select Edit from the Objects tab.
  4. Add the object permissions outlined in the following table and select Save.
Object Read Create Edit Delete
Case Comments Yes - Yes -
Case Product Registration Yes - Yes -
Localized Substance Yes - - -

Update the Administration Actions Permission Set

  1. In Admin, go to Users & Groups > Permission Sets.
  2. Select Administration Actions.
  3. Select Edit from the Objects tab.
  4. Add the object permissions outlined in the following table and select Save.
Object Read Create Edit Delete
Case Product Registration Yes - - -
Controlled Vocabulary Yes - - -
Localization Yes - - -
Localized Case Yes - - -
Localized Case Adverse Event Yes - - -
Localized Case Assessment Yes - - -
Localized Case Assessment Result Yes - - -
Localized Case Cause of Death Yes - - -
Localized Case Contact Yes - - -
Localized Case Drug History Yes - - -
Localized Case Identifier Yes - - -
Localized Case Medical History Yes - - -
Localized Case Product Yes - - -
Localized Case Product Dosage Yes - - -
Localized Case Product Indication Yes - - -
Localized Case Product Substance Yes - - -
Localized Case Test Result Yes - - -
Localized Case Controlled Vocabulary Yes - Yes -
Localized Country Yes - Yes -
Localized Dose Form Yes - Yes -
Localized Organization Yes Yes Yes Yes
Localized Product Yes Yes Yes Yes
Localized Route of Administration Yes - Yes -
Localized Study Yes Yes Yes Yes
Localized Substance Yes Yes Yes Yes
Localized Transmission Yes Yes Yes Yes
Localized Unit of Measurement Yes - Yes -

Add Roles to the Case Comments Object Lifecycle

  1. Navigate to Admin > Configuration > Object Lifecycles > Case Comments Lifecycle.
  2. Select + from the Roles section.
  3. Add the following roles:
    • Data Entry
    • Translator
    • Head of Safety
    • Distribution Manager
  4. Select OK.
  5. Select Edit from the Roles section.
  6. Add the permissions from the following table to the roles and select Save.
Role Read Edit Delete
Data Entry Yes Yes Yes
Translator Yes Yes -
Head of Safety Yes - -
Distribution Manager Yes - -

Add Roles to the Case Product Registration Object Lifecycle

  1. Navigate to Admin > Configuration > Object Lifecycles > Case Product Registration Lifecycle.
  2. Select + from the Roles section.
  3. Add the following roles:
    • Data Entry
    • Translator
    • Head of Safety
    • Distribution Manager
  4. Select OK.
  5. Select Edit from the Roles section.
  6. Add the permissions from the following table to the roles and select Save.
Role Read Edit Delete
Data Entry Yes Yes Yes
Translator Yes Yes -
Head of Safety Yes - -
Distribution Manager Yes - -

Add Roles to the Localized Substance Object Lifecycle

  1. Navigate to Admin > Configuration > Object Lifecycles > Localized Substance Lifecycle.
  2. Select + from the Roles section.
  3. Add the following roles:
    • Data Entry
    • Translator
    • Head of Safety
    • Distribution Manager
  4. Select OK.
  5. Select Edit from the Roles section.
  6. Add the permissions from the following table to the roles and select Save.
Role Read Edit Delete
Data Entry Yes - -
Translator Yes - -
Head of Safety Yes - -
Distribution Manager Yes - -

Add Sharing Rules to the Case Comments Object Lifecycle

  1. Navigate to Admin > Configuration > Object Lifecycles > Case Comments Lifecycle.
  2. Select Edit from the Details tab.
  3. Select Enable Matching Sharing Rules.
  4. Select Create from the Sharing Rules tab.
  5. Add the sharing rules outlined in the following table and select Save.
Label Role Rule Criteria
Case Comments - Data Entry Data Entry Organization
Case Comments - Distribution Distribution Manager Organization
Case Comments - Head of Safety Head of Safety Organization
Case Comments - Translator Translator Organization

Add Sharing Rules to the Case Product Registration Object Lifecycle

  1. Navigate to Admin > Configuration > Object Lifecycles > Case Product Registration Lifecycle.
  2. Select Edit from the Details tab.
  3. Select Enable Matching Sharing Rules.
  4. Select Create from the Sharing Rules tab.
  5. Add the sharing rules outlined in the following table and select Save.
Label Role Rule Criteria
Case Comments - Data Entry Data Entry Organization
Case Comments - Distribution Distribution Manager Organization
Case Comments - Head of Safety Head of Safety Organization
Case Comments - Translator Translator Organization