# 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 <a href="/en/lr/696910/#lrd-section">Complete Intake and Process Cases for the PMDA</a>.

## 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:

* <a href="/en/lr/01309/">PMDA Multi-Submission with Localized Case</a>
* <a href="/en/lr/01315/">PMDA Local Case Processing Automations</a>
* <a href="/en/lr/01369/">PMDA Due Dates Based on Localized Case Assessments</a>
* <a href="/en/lr/01298/">PMDA Clinical Trial Reporting Enhancements</a>

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

To configure the _Generate Local Reporting Details_ action:

1. <a href="/en/lr/43127/#assign-actions">Assign</a> the action to the _Case_ and _Localized Case_ objects.
    2. (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 <a href="/en/lr/59885/#define-actions">user action</a> to the following _Case_ object lifecycle states:
    * _Data Entry (Initial)_
    * _Data Entry (Reopened)_
    * _Revision_
3. Add the action as an <a href="/en/lr/59885/#entry-actions">entry action</a> to the following _Localized Case_ object lifecycle states:
    * _Active_
    * _Revision_

## Update the Case Product Registration Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Due Date_ and _Due in Days_ fields to the _Case Product Registration_ object layout.

## Update the Local Reporting Details Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _System Generated LRD Category_ field to the _Local Reporting Details_ object layout.

## Update the Localized Case Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Due Date_ field to the _Localized Case_ object layout.

## Update the Localized Case Assessment Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> 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:

* <a href="#add-lst-field">Add a Localization State Type</a>
* <a href="#update-tp">Update the Transmission Profile Layout</a>
* <a href="#config-lt">Configure Localize Transmission on the Transmission Profile</a>

### <a id="add-lst-field"></a>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 {#update-tp}

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Localize Transmission_ field to the _Transmission Profile_ object layout for system gateways.

### Configure Localize Transmission on the Transmission Profile {#config-lt}

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**.