Enable PMDA E2B(R3) Export

Learn how to update your vault's configuration to enable PMDA E2B(R3) exports for ICSR submissions to the PMDA.

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About the Feature

Vault Safety 21R3 introduced support to export PMDA E2B(R3) files for individual cases. This page outlines the configuration required to use this feature.

Vaults originally deployed from the 21R3 release template (December 2021) will have this configuration already.

Once this feature is enabled, for more information about PMDA Submissions, see the following pages:

Ensure your vault has the following configuration to enable data entry of Japan local fields and submissions to the PMDA:

  1. Enable Localized Submissions and Translation Support
  2. Enable Local Fields for PMDA (Japan)
  3. Enable PMDA (Japan) Submission Rules

Update Localized Case Page Layout

  1. In the Admin area, go to Configuration > Objects > Localized Case.
  2. On the Page Layouts tab, open the Localized Case Detail Page Layout for editing.
  3. Add a Related Object section with the following section settings:
    Setting Value
    Section Type Related Object
    Related Object Localized Case Document
    Section Label Documents
    Creation Option Prevent record creation
    Columns
    • Name
    • Document
    • Attachment Description
  4. (Optional) Move the Documents section above the Submissions & Distributions section.
updated-localized-case-layout
Updated Localized Case Page Layout

Update Case Product Registration Page Layout

  1. Go to Configuration > Objects > Case Product Registration.
  2. On the Page Layouts tab, open the Japan Detail Page Layout for editing.
  3. Add the following fields:
    • PMDA Rank
    • OTC Drug Channel Control
  4. Remove the following fields, which are now replaced by the field control added in step 3:
    • OTC Drug Channel
    • OTC Drug Channel Reason Omitted
updated-case-product-registration-layout
Updated Japan Case Product Registration Layout

Configure the Localized Case Document Object

Configure the page layout and security for the new Localized Case Document object.

Update the Localized Case Document Page Layout

  1. Go to Configuration > Objects > Localized Case Document.
  2. On the Page Layouts tab, open the Localized Case Document Detail Page Layout for editing.
  3. Edit the page layout to match the following sections:
    Section Fields
    Details
    • Localized Case
    • Document
    • Attachment Description
    • Reference Text
    Workflow Timeline N/A
    System
    • Organization
    • Name
    • Created By
    • Created Date
    • Last Modified By
    • Last Modified Date
localized-case-document-layout
Localized Case Document Layout

Configure Security Settings for Localized Case Document

  1. Go to Configuration > Objects > Localized Case Document.
  2. Select Edit, and then enable the following settings under Options:
    • Enable Matching Sharing Rules
    • Use Action security to control Audit Trail

Secure Localized Case Document Relationship to Localized Case Field

  1. Go to Configuration > Objects > Localized Case Document.
  2. Go to the Fields tab.
  3. Open the Localized Case (localized_case__v) field.
  4. Select Edit, and then enable the Secure relationship option.

Add Localized Case Document Matching Sharing Rules

  1. Go to Configuration > Objects > Localized Case Document.
  2. Go to the Sharing Rules tab.
  3. Add the following Sharing Rules:
    Label Application Role
    Localized Case Document - Data Entry Data Entry
    Localized Case Document - Distribution Manager Distribution Manager
    Localized Case Document - Head of Safety ICSR Approver
    Localized Case Document - Translator Translator
    Sharing Rules for Localized Case Document
    Sharing Rules for Localized Case Document
  4. For each sharing rule, configure the matching criteria to use the Organization (organization__v) field:
    Rule Criteria
    Rule Criteria

Grant Permissions to Localized Case Document

  1. Go to Users & Groups > Permission Sets > Case Translation Actions.
  2. On the Objects tab, grant the following permissions for the Localized Case Document object:
    • Read
    • Edit

    Leave the default settings for the field permissions. That is, Read access on all fields.

Add Roles and Permissions to Localized Case Document Lifecycle

  1. Go to Configuration > Object Lifecycles > Localized Case Document Lifecycle.
  2. Edit the lifecycle to add the following user roles, under Roles:
    • Data Entry
    • Distribution Manager
    • ICSR Approver (previously named Head of Safety)
    • Translator
  3. Configure permissions for each role per the following table:
    Lifecycle State Role Permission
    Read Edit Delete
    Inactive Data Entry X X X
    Distribution Manager X - -
    Editor X X X
    ICSR Approver (previously named Head of Safety) X - -
    Owner X X X
    Translator X X -
    Viewer X - -
    Locked Data Entry X - -
    Distribution Manager X - -
    Editor X - -
    ICSR Approver (previously named Head of Safety) X - -
    Owner X - -
    Translator X - -
    Viewer X - -
    Closed Data Entry X - -
    Distribution Manager X - -
    Editor X - -
    ICSR Approver (previously named Head of Safety) X - -
    Owner X - -
    Translator X - -
    Viewer X - -
    Active Data Entry X X X
    Distribution Manager X - -
    Editor X X X
    ICSR Approver (previously named Head of Safety) X - -
    Owner X X -
    Translator X X -
    Viewer X - -

Add Entry Actions for Localized Case Lifecycle States

From Configuration > Object Lifecycles > Localized Case Lifecycle, add the following lifecycle state entry actions:

State Entry Action
Revision Change state to Active for records that are related by Localized Case Document
Approved Change state to Locked for records that are related by Localized Case Document
Closed Change state to Closed for records that are related by Localized Case Document

Add Atomic Security Relationships to Localized Case Lifecycle

  1. Go to Configuration > Object Lifecycles > Localized Case Lifecycle.
  2. Under States, open the following states:
    • Approved
    • Closed
  3. On each state, edit the Atomic Security: Relationships to default to Read for the Localized Case Document object.

Update Transmission Profile Page Layout

  1. Go to Configuration > Objects > Transmission Profile.
  2. On the Page Layouts tab, open the System Gateway Detail Page Layout for editing.
  3. Add a Related Object section with the following section settings:
    Setting Value
    Section Type Related Object
    Related Object Email Destination
    Section Label Recipients
    Columns
    • Name
    • Destination Person
    • Recipient Type
    • Transmission Profile
    • Destination Person > Country
    • Destination Person > Title
    • Destination Person > Name
    Updated Transmission Profile Layout
    Updated System Gateway Transmission Profile Page Layout
  4. Add the following Layout Rule:
    Setting Value
    Label Hide PMDA
    Hide the following Page Layout Items
    Type Values
    Sections Recipients
    IF this Layout Rule Expression is TRUE api_name__v != 'jp_pmda__v'
    Hide Recipients Section Layout Rule
    Hide Recipients Section Layout Rule
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