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

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 Layout

  1. In the Admin area, go to Configuration > Objects > Localized Case.
  2. On the Layouts tab, open the Localized Case Detail Page Layout for editing.
  3. Insert a Related Object section with the following settings:
    • 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

Update Case Product Registration Layout

  1. Go to Configuration > Objects > Case Product Registration.
  2. On the 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

Configure the Localized Case Document Object

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

Update the Localized Case Document Layout

  1. Go to Configuration > Objects > Localized Case Document.
  2. On the Layouts tab, open the Localized Case Document Detail Page Layout for editing.
  3. Edit the Details section to include the following fields:
    • Localized Case
    • Document
    • Attachment Description
    • Reference Text
  4. Insert the Workflow Timeline section without any fields.
  5. Edit the System section to include the following fields:
    • Organization
    • Name
    • Created By
    • Created Date
    • Last Modified By
    • Last Modified Date

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 Sharing Rules as follows:
    • Add the Localized Case Document - Data Entry sharing rule to the Data Entry application role
    • Add the Localized Case Document - Distribution Manager sharing rule to the Distribution Manager application role
    • Add the Localized Case Document - Head of Safety sharing rule to the ICSR Approver application role
    • Add the Localized Case Document - Translator sharing rule to the Translator application role Sharing Rules for Localized Case Document
  4. For each sharing rule, configure the matching criteria to use the Organization (organization__v) field: 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 Layout

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