Enable PMDA Local Reporting Details Generation and Submission Linking

To support PMDA multi-submission requirements, Case Processors can now generate local reporting details, which drive Transmission generation. Through a single action, users generate Local Reporting Details, Product Joins, and Localized Case Comments based on Japan Case Product Registrations. Previously, users had to manually create and link these records, which was time-consuming and error-prone.

After configuring this feature, learn more about the Local Reporting Details section in Complete Intake and Process Cases for the PMDA.

24R1 Update: PMDA Local Reporting Details Generation and Submission Linking Enablement

With the 24R1 release, the PMDA Local Reporting Details Generation and Submission Linking feature no longer requires Support enablement.

Prerequisite

This feature is Auto-on, however, some components require additional configuration. Before configuring this feature, ensure you have also enabled the following features:

Configure the Generate Local Reporting Details Action on Cases and Localized Cases

To configure the Generate Local Reporting Details action:

  1. Assign the action to the Case and Localized Case objects.
    1. (Optional) On the Create Action page, enter the following Description: Generate Local Reporting Details on [Domestic OR Localized] Cases for Japan.
  2. Add the action as a user action to the following Case object lifecycle states:
    • Data Entry (Initial)
    • Data Entry (Reopened)
    • Revision
  3. Add the action as an entry action to the following Localized Case object lifecycle states:
    • Active
    • Revision

Update the Case Product Registration Layout

Add the Due Date and Due in Days fields to the Case Product Registration object layout.

Update the Local Reporting Details Layout

Add the System Generated LRD Category field to the Local Reporting Details object layout.

Update the Localized Case Layout

Add the Due Date field to the Localized Case object layout.

Update the Localized Case Assessment Layout

Add the Due Date and Due in Days fields to the Localized Case Assessment object layout.

Configure a Non-Submittable Localization State for PMDA Submissions

To support multiple submissions from a single Case to the PMDA, Transmissions for the PMDA must now be associated with Local Reporting Details, a child object of Localized Case, to be reportable.

To generate PMDA Submissions in an interim state, which are not submittable until Local Reporting Details are linked to the Submission, you must complete the following procedures:

Add a Localization State Type

Configure a Localization State Type in which non-submittable PMDA Submissions will be generated.

  1. Navigate to Admin > Configuration > Object Lifecycles > Transmission Lifecycle.
  2. In the State Type section, select Create.
  3. On the Create State Type Association page, complete the fields as follows:
    • State Type: Select Localization State
    • State: Select the state in which the non-submittable Submission will be generated. For example, Not Ready for Transmission, Waiting for Localization, or any state that is suitable for your organization’s business process. If an appropriate option does not exist, follow the steps below to create a state before configuring a Localization State Type.

(Optional) Create a State for the Localization State Type Setting

To configure a new state to apply to the Localization State Type setting:

  1. Navigate to Admin > Configuration > Object Lifecycles > Transmission Lifecycle.
  2. In the States section, select Create.
  3. In the State Label field, enter a name for the state. Vault populates the State Name field based on your entry.
  4. Select Save.

Update the Transmission Profile Layout

Add the Localize Transmission field to the Transmission Profile object layout for system gateways.

Configure Localize Transmission on the Transmission Profile

To configure the Localize Transmission setting on the PMDA Transmission Profile:

  1. Navigate to Business Admin > Objects > Transmission Profiles > PMDA.
  2. Select Edit.
  3. In the Details section, set the Localize Transmission field to Yes.
  4. Select Save.

Set the PMDA Reporting Rule Version to 3

To update the Active PMDA ICSR Reporting Rule Set to version 3.0, complete the following steps:

  1. Navigate to Business Admin > Objects > Safety Rule Sets > PMDA ICSR Reporting Rule Set.
  2. Select Edit
  3. In the Active Rule Version field, enter “3”.
  4. Select Save.