Enable Local Fields for PMDA (Japan)

Learn how to update your vault's configuration to enable Japanese localization fields.

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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.

Note Before you enable this feature, the configuration for Localized Submissions and Translation Support must be complete.

Update the Product Registration Page Layout

  1. In Admin, go to Configuration > Objects > Product Registration.
  2. On the Page Layouts tab, open the Product Registration Detail Page Layout.
  3. Select Detail Form from the Add Section drop-down menu.
  4. Complete the Add Detail Form form with the following details:
    • Section Label: PMDA
    • Section Name: pmda__c
  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.

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Add the E2B Field to the Localized Dose Form Page Layout

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

  6. Select Save.

Add the Localized Substance Section to the Substance Page Layout

  1. In Admin, go to Configuration > Objects > Substance.
  2. On the Page Layouts tab, open the Substance Detail Page Layout.
  3. Select Related Object from the Add Section drop-down menu.
  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 Page Layout

  1. In Admin, go to Configuration > Objects > Study.
  2. On the Page 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 Page Layout

Add the PMDA Detail Section

  1. In Admin, go to Configuration > Objects > Localized Study.
  2. On the Page Layouts tab, open the Localized Study Detail Page Layout.
  3. Select Detail Form from the Add Section drop-down menu.
  4. Complete the Add Detail Form form with the following details:
    • Section Label: PMDA
    • Section Name: pmda__c
  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 Page 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 Page Layout

  1. In Admin, go to Configuration > Objects > Localized Case Product.
  2. On the Page 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 Page Layout

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

  6. Select Save.

Create the Japan Page Layout for the Case Product Registration Object

  1. In Admin, go to Configuration > Objects > Case Product Registration.
  2. Select Create on the Page Layouts tab.
  3. Complete the Add Page Layout form with the following details:
    • Object Type: Japan
    • Page Layout Label: Japan Detail Page Layout
    • Page Layout Name: japan_detail_page_layout
  4. Select Create.
  5. Configure the Japan Page Layout to match the following image:
  6. alt-text
  7. Select Save.

Configure the Case Comments Object

Add the Organization Custom Field

  1. In Admin, go to 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
    • Name: organization__c
    • Lookup Relationship: Case (case__vr)
    • Lookup Source Field: Organization
  4. Select Save.

Update the Case Comments Page Layout

  1. In Admin, go to Configuration > Objects > Case Comments.
  2. On the Page Layouts tab, open the Case Comments Detail Page Layout.
  3. Configure the Details section to match the following image:
  4. alt-text
  5. Select Save.

Security

Update the Case Translation Actions Permission Set

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

Update the Administration Actions Permission Set

  1. In Admin, go to Configuration > Users & Groups > Permission Sets.
  2. Select Administration Actions.
  3. Select Edit from the Objects tab.
  4. Add the following object permissions:
    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 -
  5. Select Save.

Add Roles to the Case Comments Object Lifecycle

  1. In Admin, go to 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 following permissions to the roles:
    Name Read Edit Delete
    Data Entry Yes Yes Yes
    Translator Yes Yes -
    Head of Safety Yes - -
    Distribution Manager Yes - -
  7. Select Save.

Add Roles to the Case Product Registration Object Lifecycle

  1. In Admin, go to 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 following permissions to the roles:
    Name Read Edit Delete
    Data Entry Yes Yes Yes
    Translator Yes Yes -
    Head of Safety Yes - -
    Distribution Manager Yes - -
  7. Select Save.

Add Roles to the Localized Substance Object Lifecycle

  1. In Admin, go to 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 following permissions to the roles:
    Name Read Edit Delete
    Data Entry Yes - -
    Translator Yes - -
    Head of Safety Yes - -
    Distribution Manager Yes - -
  7. Select Save.

Add Sharing Rules to the Case Comments Object Lifecycle

  1. In Admin, go to 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 following sharing rules:
    Label Name Role Rule Criteria
    Case Comments - Data Entry case_comments_data_entry__c Data Entry Organization
    Case Comments - Distribution case_comments_distribution__c Distribution Manager Organization
    Case Comments - Head of Safety case_comments_head_of_safety__c Head of Safety Organization
    Case Comments - Translator case_comments_translator__c Translator Organization
  6. Select Save.

Add Sharing Rules to the Case Product Registration Object Lifecycle

  1. In Admin, go to 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 following sharing rules:
    Label Name Role Rule Criteria
    Case Comments - Data Entry case_comments_data_entry__c Data Entry Organization
    Case Comments - Distribution case_comments_distribution__c Distribution Manager Organization
    Case Comments - Head of Safety case_comments_head_of_safety__c Head of Safety Organization
    Case Comments - Translator case_comments_translator__c Translator Organization
  6. Select Save.

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