# Enable Local Fields for PMDA (Japan)

Learn how to update your Vault's configuration to enable Japanese localization fields.

## About the Feature

Support for local fields for PMDA (Japan) was added in 21R1. Vaults created in 21R2 or later include the necessary configuration by default, while Vaults originally deployed earlier than 21R2 must have the configuration upgrades described on this page to enable this feature.



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      <p><strong>Note</strong>:  Before you enable this feature, the configuration for <a href="/en/gr/01358/">Localized Submissions and Translation Support</a> must be complete.</p>
    </div>
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## Update the Product Registration Layout

1. Navigate to **Admin > Configuration > Objects > Product Registration**.
2. On the **Layouts** tab, open the **Product Registration Detail Page Layout**.
3. Insert a **Detail Form** section.
4. Complete the **Add Detail Form** form with the following details:
    * **Section Label:** PMDA
5. Select **Done**.
6. Add the following fields to the **PMDA Detail** section:
    * Dose Form
    * Japan Product Code Type
    * Clinical Compound Number
    * OTC Drug Classification
7. Select **Add** from the **Registration Details** section.
8. Select **Local Product Code**.
9. Select **Save**.

## Add the E2B Field to the Localized Dose Form Layout

1. Navigate to **Admin > Configuration > Objects > Localized Dose Form**.
2. On the **Layouts** tab, open the **Localized Dose Form Detail Page Layout**.
3. Select **Add** from the **Details** section.
4. Select **E2B Code**. We recommend placing this field above the **Localization** field.
5. Select **Save**.

## Insert the Localized Substance Section on the Substance Layout

1. Navigate to **Admin > Configuration > Objects > Substance**.
2. On the **Layouts** tab, open the **Substance Detail Page Layout**.
3. Insert a **Related Object** section.
4. Complete the **Add Related Object** form with the following details:
    * **Related Object:** Localized Substance
    * **Section Label:** Localized Substances
    * **Create Option:** Create record in new page
    * We recommend placing the **Localized Substance** section above the **Workflow Timeline** section.
5. Select **Done**.

## Add the Development Phase Field to the Study Layout

1. Navigate to **Admin > Configuration > Objects > Study**.
2. On the **Layouts** tab, open the **Study Detail Page Layout**.
3. Select **Add** from the **Details** section.
4. Select **Development Phase**.
5. Select **Save**.

## Update the Localized Study Layout

### Insert the PMDA Detail Section

1. Navigate to **Admin > Configuration > Objects > Localized Study**.
2. On the **Layouts** tab, open the **Localized Study Detail Page Layout**.
3. Insert a **Detail Form** section.
4. Complete the **Add Detail Form** form with the following details:
    * **Section Label:** PMDA
5. Select **Done**.
6. Add the following fields to the **PMDA Detail** section:
    * Target Disease
    * Existence of Subjects
    * Number of Clinical Trial Notifications
7. Select **Save**.

## Update the Localized Case Layout

### Update the Details Section

1. Select **Add** from the **Details** section.
2. Add the following fields:
    * Local Awareness Date
    * Localized Parent Information
3. Select **Save**.

### Add the Local MPID Field to the Localized Case Product Layout

1. Navigate to **Admin > Configuration > Objects > Localized Case Product**.
2. On the **Layouts** tab, open the **Localized Case Product Detail Page Layout**.
3. Select **Add** from the **Details** section.
4. Select **Local MPID**.
5. Select **Save**.

### Add the Local Product Code Field to the Localized Case Product Substance Layout

1. Navigate to **Admin > Configuration > Objects > Localized Case Product Substance**.
2. On the **Layouts** tab, open the **Localized Case Product Substance Detail Page Layout**.
3. Select **Add** from the **Details** section.
4. Select **Local Product Code**. We recommend placing this field above the **Organization** field.
5. Select **Save**.

### Create the Japan Layout for the Case Product Registration Object

1. Navigate to **Admin > Configuration > Objects > Case Product Registration**.
2. Select **Create** on the **Layouts** tab.
3. Complete the **Add Layout** form with the following details:
    * **Object Type:** Japan
    * **Layout Label:** Japan Detail Page Layout
4. Select **Create**.
5. Configure the **Japan Detail Page Layout** with the sections and fields/columns as shown in the table below.
6. Select **Save**.

<table>
  <col style="width:20%">
  <col style="width:50%">
  <col style="width:30%">
  <thead>
    <tr>
      <th>Section</th>
      <th>Settings</th>
      <th>Fields/Columns</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>Details</em></td>
      <td>
        <ul>
          <li><strong>Type</strong>: <em>Detail Form</em></li>
          <li><strong>Section Label</strong>: <em>Details</em></li>
          <li><strong>Section Name</strong>: <code>details__c</code></li>
          <li><strong>Section Layout</strong>: <em>Detail Form - Two Columns</em></li>
        </ul>
      </td>
      <td>
        <ul>
          <li><em>Name</em></li>
          <li><em>Case</em></li>
          <li><em>Localized Case</em></li>
          <li><em>Case Product</em></li>
          <li><em>Product</em></li>
          <li><em>Rank</em></li>
          <li><em>Product Registration</em></li>
          <li><em>Registration Type</em></li>
          <li><em>Registration Country</em></li>
          <li><em>Registration Holder/Applicant</em></li>
          <li><em>Registration Number</em></li>
          <li><em>Dose Form</em></li>
          <li><em>Local Product Code</em></li>
          <li><em>OTC Drug Classification</em></li>
          <li><em>OTC Drug Channel</em></li>
          <li><em>Product (Reported)</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Reporting Information</em></td>
      <td>
        <ul>
          <li><strong>Type</strong>: <em>Detail Form</em></li>
          <li><strong>Section Label</strong>: <em>Reporting Information</em></li>
          <li><strong>Section Name</strong>: <code>reporting_information__c</code></li>
          <li><strong>Section Layout</strong>: <em>Detail Form - Two Columns</em></li>
        </ul>
      </td>
      <td>
        <ul>
          <li><em>PMDA Reporting Category</em></li>
          <li><em>Completeness</em></li>
          <li><em>Immediate Report Type</em></li>
          <li><em>Report Overview</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Case Comments</em></td>
      <td>
        <ul>
          <li><strong>Type</strong>: <em>Related Object</em></li>
          <li><strong>Related Object</strong>: <em>Localized Case Comment</em></li>
          <li><strong>Section Label</strong>: <em>Case Comments</em></li>
          <li><strong>Section Name</strong>: <code>case_comments__c</code></li>
        </ul>
      </td>
      <td>
        <ul>
          <li><em>Name</em></li>
          <li><em>Comments Label</em></li>
          <li><em>Comments Text</em></li>
          <li><em>Case Product Registration</em></li>
        </ul>
      </td>
    </tr>
  </tbody>
</table>

### Configure the Case Comments Object

#### Add the Organization Custom Field

1. Navigate to **Admin > Configuration > Objects > Case Comments**.
2. Select **Create** on the **Fields** tab.
3. Complete the **Create Field** form with the following information:
    * **Field Type:** Lookup
    * **Label:** Organization
    * **Lookup Relationship:** `Case (case__vr)`
    * **Lookup Source Field:** Organization
4. Select **Save**.

### Update the Case Comments Layout

1. Navigate to **Admin > Configuration > Objects > Case Comments**.
2. On the **Layouts** tab, open the **Case Comments Detail Page Layout**.
3. Configure the **Details** section fields as follows:
   * _Case_
   * _Localized Case_
   * _Case Product_
   * _Case Product Registration_
   * _Comments Label_
   * _Comments Text_
4. Select **Save**.

## Security

### Update the Case Translation Actions Permission Set

1. In Admin, go to **Users & Groups > Permission Sets**.
2. Select **Case Translation Actions**.
3. Select **Edit** from the **Objects** tab.
4. Add the object permissions outlined in the following table and select **Save**.

| Object | Read | Create | Edit | Delete
|--- |--- |--- |--- |---
| Case Comments | Yes | - | Yes | -
| Case Product Registration | Yes | - | Yes | -
| Localized Substance | Yes | - | - | -

### Update the Administration Actions Permission Set

1. In Admin, go to **Users & Groups > Permission Sets**.
2. Select **Administration Actions**.
3. Select **Edit** from the **Objects** tab.
4. Add the object permissions outlined in the following table and select **Save**.

| Object | Read | Create | Edit | Delete
|--- |--- |--- |---
| Case Product Registration | Yes | - | - | -
| Controlled Vocabulary | Yes | - | - | -
| Localization | Yes | - | - | -
| Localized Case | Yes | - | - | -
| Localized Case Adverse Event | Yes | - | - | -
| Localized Case Assessment | Yes | - | - | -
| Localized Case Assessment Result | Yes | - | - | -
| Localized Case Cause of Death | Yes | - | - | -
| Localized Case Contact | Yes | - | - | -
| Localized Case Drug History | Yes | - | - | -
| Localized Case Identifier | Yes | - | - | -
| Localized Case Medical History | Yes | - | - | -
| Localized Case Product | Yes | - | - | -
| Localized Case Product Dosage | Yes | - | - | -
| Localized Case Product Indication | Yes | - | - | -
| Localized Case Product Substance | Yes | - | - | -
| Localized Case Test Result | Yes | - | - | -
| Localized Case Controlled Vocabulary | Yes | - | Yes | -
| Localized Country | Yes | - | Yes | -
| Localized Dose Form | Yes | - | Yes | -
| Localized Organization | Yes | Yes | Yes | Yes
| Localized Product | Yes | Yes | Yes | Yes
| Localized Route of Administration | Yes | - | Yes | -
| Localized Study | Yes | Yes | Yes | Yes
| Localized Substance | Yes | Yes | Yes | Yes
| Localized Transmission | Yes | Yes | Yes | Yes
| Localized Unit of Measurement | Yes | - | Yes | -

### Add Roles to the Case Comments Object Lifecycle

1. Navigate to **Admin > Configuration > Object Lifecycles > Case Comments Lifecycle**.
2. Select **+** from the **Roles** section.
3. Add the following roles:
    * Data Entry
    * Translator
    * Head of Safety
    * Distribution Manager
4. Select **OK**.
5. Select **Edit** from the **Roles** section.
6. Add the permissions from the following table to the roles and select **Save**.

| Role | Read | Edit | Delete
|--- |--- |--- |---
| Data Entry | Yes | Yes | Yes
| Translator | Yes | Yes | -
| Head of Safety | Yes | - | -
| Distribution Manager | Yes | - | -

### Add Roles to the Case Product Registration Object Lifecycle

1. Navigate to **Admin > Configuration > Object Lifecycles > Case Product Registration Lifecycle**.
2. Select **+** from the **Roles** section.
3. Add the following roles:
    * Data Entry
    * Translator
    * Head of Safety
    * Distribution Manager
4. Select **OK**.
5. Select **Edit** from the **Roles** section.
6. Add the permissions from the following table to the roles and select **Save**.

| Role | Read | Edit | Delete
|--- |--- |--- |---
| Data Entry | Yes | Yes | Yes
| Translator | Yes | Yes | -
| Head of Safety | Yes | - | -
| Distribution Manager | Yes | - | -

### Add Roles to the Localized Substance Object Lifecycle

1. Navigate to **Admin > Configuration > Object Lifecycles > Localized Substance Lifecycle**.
2. Select **+** from the **Roles** section.
3. Add the following roles:
    * Data Entry
    * Translator
    * Head of Safety
    * Distribution Manager
4. Select **OK**.
5. Select **Edit** from the **Roles** section.
6. Add the permissions from the following table to the roles and select **Save**.

| Role | Read | Edit | Delete
|--- |--- |--- |---
| Data Entry | Yes | - | -
| Translator | Yes | - | -
| Head of Safety | Yes | - | -
| Distribution Manager | Yes | - | -

### Add Sharing Rules to the Case Comments Object Lifecycle

1. Navigate to **Admin > Configuration > Object Lifecycles > Case Comments Lifecycle**.
2. Select **Edit** from the **Details** tab.
3. Select **Enable Matching Sharing Rules**.
4. Select **Create** from the **Sharing Rules** tab.
5. Add the sharing rules outlined in the following table and select **Save**.

| Label | Role | Rule Criteria
|--- |--- |---
| Case Comments - Data Entry | Data Entry | Organization
| Case Comments - Distribution | Distribution Manager | Organization
| Case Comments - Head of Safety | Head of Safety | Organization
| Case Comments - Translator | Translator |  Organization

### Add Sharing Rules to the Case Product Registration Object Lifecycle

1. Navigate to **Admin > Configuration > Object Lifecycles > Case Product Registration Lifecycle**.
2. Select **Edit** from the **Details** tab.
3. Select **Enable Matching Sharing Rules**.
4. Select **Create** from the **Sharing Rules** tab.
5. Add the sharing rules outlined in the following table and select **Save**.

| Label | Role | Rule Criteria
|--- |--- |---
| Case Comments - Data Entry | Data Entry | Organization
| Case Comments - Distribution | Distribution Manager | Organization
| Case Comments - Head of Safety | Head of Safety | Organization
| Case Comments - Translator | Translator |  Organization