Enable PMDA Local Reporting Details Generation and Submission Linking

Learn how to configure your Vault with options for generating Local Reporting Details and linking Submissions.

About the Feature

To support PMDA multi-Submission requirements, Vault Safety now gives Case Processors the ability to generate Local Reporting Details that drive Submission generation. Completed in a single action, this feature generates Local Reporting Details, Product Joins, and Localized Case Comments based on Case Product Registrations that are reportable to Japan. Previously, these records required manual creation and linking, 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:

• PMDA Multi-Submission with Localized Case
• PMDA Local Case Processing Automations
• PMDA Due Dates Based on Localized Case Assessments
• PMDA Clinical Trial Reporting Enhancements

Add the Generate Local Reporting Details Action to the Case and Localized Case Objects

To add the Generate Local Reporting Details action to the Case and Localized Case objects, complete the following steps:

1. Go to Admin > Configuration > Objects > [object] > Actions.
2. Select Create.
3. In the Create Action window, select Generate Local Reporting Details from the picklist and then select Continue.
4. (Optional) On the Create Action page, in the Description field, enter “Generate Local Reporting Details on [Domestic OR Localized] Cases for Japan.”
5. Select Save.

Add the Generate Local Reporting Details User Action to the Case and Localized Case Object Lifecycles

Add the Generate Local Reporting Details action to the following object lifecycles and states:

Object Lifecycle	State
Case	Data Entry (Initial) Data Entry (Reopened) Revision
Localized Case	Active Revision

Complete the following steps to update the object lifecycles:

1. Go to Admin > Configuration > Object Lifecycles > [object lifecycle] > States.
2. Select a state.
3. In the User Actions section, select Edit and then select Create Rule.
4. Select Always.
5. Under Allow the following actions:
   • Select Generate Local Reporting Details.
   • In the Action Label field, enter “Generate Local Reporting Details”.
6. Select Save.

Update the Case Product Registration Layout

To add the Due Date and Due in Days fields to the Case Product Registration layout, complete the following steps:

1. Go to Admin > Configuration > Objects > Case Product Registration > Layouts > Japan Detail Page Layout.
2. In the Details section, add the following fields:
   • Due Date
   • Due in Days
3. Select Save.

Update the Local Reporting Details Layout

To add the System Generated LRD Category field to the Local Reporting Details layout, complete the following steps:

1. Go to Admin > Configuration > Objects > Local Reporting Details > Layouts > Local Reporting Details Detail Page Layout.
2. In the System section, add the System Generated LRD Category field.
3. Select Save.

Update the Localized Case Layout

To add the Due Date field to the Localized Case layout, complete the following steps:

1. Go to Admin > Configuration > Objects > Localized Case > Layouts > Localized Case Detail Page Layout.
2. In the Details section, add the Due Date field.
3. Select Save.

Update the Localized Case Assessment Layout

To add the Due Date and Due in Days fields to the Localized Case Assessment layout, complete the following steps:

1. Go to Admin > Configuration > Objects > Localized Case Assessment > Layouts > Localized Case Assessment Detail Page Layout.
2. In the Details section, add the following fields:
   • Due Date
   • Due in Days
3. Select Save.

Configure a Non-Submittable Localization State for PMDA Submissions

To support multiple submissions from a single Case to the PMDA, Transmission records for the PMDA must now be associated with Local Reporting Details, which is 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
• Update the Transmission Profile Layout
• Configure Localize Transmission on the Transmission Profile

Add a Localization State Type

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

1. Go 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 name that is suitable for your organization’s business process. If an appropriate option is not already configured, follow the steps below to create a state before configuring a Localization State Type.

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

If you want to configure a new state to apply to the Localization State Type setting, complete the following steps:

1. Go 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. The system auto-populates the State Name field based on your entry.
4. Select Save.

Update the Transmission Profile Layout

To add the Localize Transmission field to the Transmission Profile layout, complete the following steps:

1. Go to Admin > Configuration > Objects > Transmission Profile > Layouts > System Gateway Detail Page Layout.
2. In the Details section, add the Localize Transmission field.
3. Select Save.

Configure Localize Transmission on the Transmission Profile

To configure the Localize Transmission setting on the PMDA Transmission Profile, complete the following steps:

1. Go 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. Go 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.