# Enable Localized Submissions and Translation Support

Learn how to update your Vault's configuration to enable localized submissions and language translation support.

## About the Feature

Support for Localized Submissions was first added in 20R3. Vaults originally deployed in 20R3 or later include some of the required configurations by default.

However, additional changes to the Veeva Safety template were introduced in 21R2 to address data model issues with localized objects introduced in 20R3. Throughout this article, sections are prepended with (21R2) to identify configuration added in 21R2.

Vaults deployed from 21R2 and later already have the necessary configuration for this feature. 

## (Optional) Navigation

Optionally, add a **Localized Cases** navigation tab:

1. In Admin, go to **Configuration > Tabs**.
2. Select **Create**.
3. Create the **Localized Cases** tab with the following details: 
    * **Label**: Localized Cases
    * **Tab Type**: Object
    * **Object**: Localized Cases
    * **Creation Options**: Prevent record creation
4. Select **Save**.

## Configure the Localized Country Object

The following configurations are required for enabling localized submissions.

### Insert the Localized Country Section on the Country Layout

1. In Admin, go to **Configuration > Objects > Country**.
2. On the **Layouts** tab, open the **Country Detail Page Layout**.
3. Insert a **Related Object** section.
4. Complete the **Add Related Object** form with the following details:
    * **Related Object**: Localized Country
    * **Create Option**: Prevent Record Creation
5. Select **Edit Columns** from the **Localized Country** related object section.
6. Add the following columns:
    * Name
    * Localization
7. Select **Done**.
8. Select **Save**.

### Hide the Localized Country Object in Business Admin

1. In Admin, go to **Configuration > Objects > Localized Country**.
2. Select **Edit**.
3. De-select **Display in Business Admin Menu**.
4. Select **Save**.

## Configure the Localized Organization Object

### Insert the Localized Organization Section on Organization Layouts

1. In Admin, go to **Configuration > Objects > Organization > Layouts**.
2. Insert the **Localized Organization** related object section on the following layouts:
    * CRO Detail Page Layout
    * Ethics Committee Detail Page Layout
    * Organization Detail Page Layout
    * Partner Detail Page Layout
    * Site Detail Page Layout
    * Sponsor Detail Page Layout
    * Vendor Detail Page Layout
3. Complete the **Add Related Object** form with the following details:
    * **Related Object**: Localized Organization
    * **Create Option**: Create record in new page
4. Select **Edit Columns** from the **Localized Organization** related object section.
5. Add the following columns:
    * Name
    * Localization
    * Official Name
6. Select **Done**.
7. Select **Save**.

### Hide the Localized Organization Object in Business Admin

1. In Admin, go to **Configuration > Objects > Localized Organization**.
2. Select **Edit**.
3. De-select **Display in Business Admin Menu**.
4. Select **Save**.

### Update the Agency Layout

1. In Admin, go to **Configuration > Objects > Organization**.
2. On the **Layouts** tab, open the **Agency Detail Page Layout**. If this layout does not exist, create a new layout for the Agency object type.
3. Add the **Localization** field to the **Details** section.
4. Insert a **Related Object** section.
5. Complete the **Add Related Object** form with the following details:
    * **Related Object**: Localized Organization
    * **Create Option**: Prevent Record Creation
6. Select **Edit Columns** from the **Localized Organization** related object section.
7. Add the following columns:
    * Name
    * Localization
    * Official Name
8. Select **Done**.
9. Select **Save**.

## Configure the Controlled Vocabulary Object

Insert the **Localized Controlled Vocabulary** section on the **Controlled Vocabulary** layout: 
1. In Admin, go to **Configuration > Objects > Controlled Vocabulary**.
2. On the **Layouts** tab, open the **Base Controlled Vocabulary Records Page Layout**.
3. Insert the **Localized Controlled Vocabulary** related object section.
4. Select **Edit Columns** from the **Localized Controlled Vocabulary** related object section.
5. Add the Localization column.
6. Select **Done**.
7. Select **Save**.

## Configure the Dose Form Object

Insert the **Localized Dose Form** section on the **Dose Form** layout: 
1. In Admin, go to **Configuration > Objects > Dose Form**.
2. On the **Layouts** tab, open the **Dose Form Detail Page Layout**.
3. Insert a **Related Object** section.
4. Complete the **Add Related Object** form with the following details:
    * **Related Object**: Localized Dose Form
    * **Create Option**: Prevent Record Creation
5. Select **Edit Columns** from the **Localized Dose Form** related object section.
6. Add the following columns:
    * Name
    * Localization
7. Select **Done**.
8. Select **Save**.

## Configure the Study Object

Insert the **Localized Study** section on the **Study** layout: 
1. In Admin, go to **Configuration > Objects > Study**.
2. On the **Layouts** tab, open the **Study Detail Page Layout**.
3. Insert a **Related Object** section.
4. Complete the **Add Related Object** form with the following details:
    * **Related Object**: Localized Study
    * **Create Option**: Create record in new page
5. Select **Edit Columns** from the **Localized Study** related object section.
6. Add the following columns:
    * Name
    * Localization
    * Study Name
7. Select **Done**.
8. Select **Save**.

## (21R2) Configure the Localized Case Contact Object

### Update the Localized Case Contact Layout

1. In Admin, go to **Configuration > Objects > Localized Case Contact**.
2. On the **Layouts** tab, open the **Localized Case Contact Detail Page Layout**.
3. Edit the **Details** section to match the following configuration in this order:
    * Case
    * Localized Case
    * Title
    * First Name
    * Middle Name
    * Last Name
    * Organization
    * Department
    * Facility Name
4. Insert a **Detail Form** section.
5. Complete the **Add Detail** form with the following details:
    * **Section Label**: Address
6. Select **Done**.
7. Add the following fields to the **Address Detail** section:
    * Street
    * Street Line 2
    * City
    * State / Province
    * Contact Country
8. Select **Save**.

### (Optional) Update the Localized Study Name Field

1. In Admin, go to **Configuration > Objects > Localized Study > Fields > Name**.
2. Select **Edit**.
3. Select **System manages field value (read-only)**.
4. Enter "VV-{######}" in the **Value Format** field.
5. Select **Save**.

## (21R2) Configure the Case Object

Add a **Localized Case** column to the **Case** layout: 
1. In Admin, go to **Configuration > Objects > Case > Layouts > Case Page Layout**.
2. In the Submissions & Distributions related object section, add a column for **Localized Case**.

## Configure the Localized Case Object

### (Optional) Enable Display in Lists and Hovercards for Fields

1. In Admin, go to **Configuration > Objects > Localized Case > Fields**.
2. Select **Case**.
3. Select **Edit**.
4. Select the checkbox beside **display in lists and hovercards**.
5. Select **Save**.
6. Go to **Configuration > Objects > Localized Case > Fields > Organization**.
7. Select **Edit**.
8. Select the checkbox beside **display in lists and hovercards**.
9. Select **Save**.

### (21R2) Configure the Localized Case Layout

Go to **Configuration > Objects > Localized Case > Layouts** and configure the **Localized Case Detail Page Layout**. See the following for detailed instructions for each section on the layout:

#### Details Section

The **Details** section should include the following fields:
* Case
* Name (Required)
* Localization
* Local Awareness Date
* Global Due Date
* Localized Parent Information
* NMPA Report Classification<br>This field should be added once <a href="/en/lr/01389/">local fields for NMPA</a> have been enabled in your Vault.
* CIOMS Remarks

#### Contacts Section
The layout should have a **Contacts** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Contact</td>
                                 <td>Contacts</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Reporter Qualification</li>
                                       <li>First Name</li>
                                       <li>Last Name</li>
                                       <li>Contact Type</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>

#### Products Section

The layout should have a **Products** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Product</td>
                                 <td>Products</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Product (Coded)</li>
                                       <li>Product (Reported)</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
                        </table>

#### Product Registrations Section

Once <a href="/en/lr/01363/">Japanese Localization Fields</a> have been enabled in your Vault, the layout should have a **Product Registrations** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Case Product Registration</td>
                                 <td>Product Registration</td>
                                 <td>Create record in new page</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Registration Country</li>
                                       <li>PMDA Reporting Category</li>
                                       <li>Product Registration</li>
                                       <li>Rank</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>

#### Case Comments Section

Once <a href="/en/lr/01363/">Japanese Localization Fields</a> have been enabled in your Vault, the layout should have a **Case Comments** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Comment</td>
                                 <td>Product Registration</td>
                                 <td>Create record in new page</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Comments Label</li>
                                       <li>Comments Text</li>
                                       <li>Case Product Registration</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
                        </table>

#### Adverse Events Section

The layout should have a **Adverse Events** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Adverse Event</td>
                                 <td>Adverse Events</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Case Adverse Event</li>
                                       <li>Event (Reported)</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
                        </table>

#### Assessments Section

The layout should have a **Assessments** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Assessment</td>
                                 <td>Assessments</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Case Assessment</li>
                                       <li>Expected</li>
                                       <li>Expected (Status)</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
                        </table>

#### Assessment Results Section

The layout should have a **Assessment Results** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Assessment Result</td>
                                 <td>Assessment Results</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Case Assessment Result</li>
                                       <li>Method (text)</li>
                                       <li>Result (text)</li>
                                       <li>Source (text)</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
                        </table>

#### Causes of Death Section

The layout should have a **Causes of Death** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Cause of Death</td>
                                 <td>Causes of Death</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Cause of Death (Reported)</li>
                                       <li>Case Cause of Death</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>

#### Medical History Section

The layout should have a **Medical History** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Medical History</td>
                                 <td>Medical History</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Condition/Procedure (Reported)</li>
                                       <li>Comments</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>

#### Drug History Section

The layout should have a **Drug History** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Drug History</td>
                                 <td>Drug History</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Drug (Coded)</li>
                                       <li>Drug (Reported)</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>                    
            
#### Test Results Section

The layout should have a **Test Results** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Test Result</td>
                                 <td>Test Results</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Test Name (Reported)</li>
                                       <li>Test Result</li>
                                       <li>Comments</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>

#### Narrative Section

The **Narrative** section should include the following fields:
* Case Narrative
* Narrative Preview
* Medical History Text
* Reporter's Comments
* Company Comments
* Additional Pregnancy Related Information<br>This field should be added once <a href="/en/lr/01389/">local fields for NMPA</a> have been enabled in your Vault.

#### Study Section

The **Study** section should include the following fields:
* Study Name
* Study Name (Continued)
* Reporting Summary
* Study Type
* MFDS Other Study Type<br>This field should be added once <a href="/en/lr/01399/">local fields for MFDS</a> have been enabled in your Vault.

#### Reference Numbers Section

The layout should have a **Reference Numbers** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Identifier</td>
                                 <td>Reference Numbers</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Case Identifier</li>
                                       <li>Source</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
                        </table>

#### Submissions & Distributions Section

The layout should have a **Submissions & Distributions** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Transmission</td>
                                 <td>Submissions & Distributions</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Lifecycle State</li>
                                       <li>Transmission Type</li>
                                       <li>Transmission Date</li>
                                       <li>Reason</li>
                                       <li>Origin</li>
                                       <li>Destination</li>
                                       <li>Due Date</li>
                                       <li>File</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
                        </table>

## (21R2) Localized Case Product

In Admin, go to **Configuration > Objects > Localized Case Product > Layouts > Localized Case Product Detail Page Layout** and configure the following sections on the layout:

### Details Section

* Localized Case
* Case Product
* Product (Reported)
* Product (Coded)
* Local MPID
* Registration Holder/Applicant
* Related Device Information<br>This field should be added once <a href="/en/lr/01389/">local fields for NMPA</a> have been enabled in your Vault.
* Other Additional Information

### Dosages Section

The layout should have a **Dosages** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Product Dosage</td>
                                 <td>Dosages</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Dose Text</li>
                                       <li>Dose (unit text)</li>
                                       <li>Dose Form Text</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>

### Indications Section

The layout should have an **Indications** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Product Indication</td>
                                 <td>Indications</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Name (Reported)</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>

### Substances Section

The layout should have an **Substances** related object section with the following settings:
<table>
                           <thead>
                              <tr>
                                 <th>Related Object</th>
                                 <th>Section Label</th>
                                 <th>Creation Option</th>
                                 <th>Columns</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Localized Case Product Substance</td>
                                 <td>Substances</td>
                                 <td>Prevent record creation</td>
                                 <td>
                                    <ul>
                                       <li>Name</li>
                                       <li>Substance Name</li>
                                    </ul>
                                 </td>
                              </tr>
                           </tbody>
</table>

## (21R2) Configure the Localized Case Assessment Object

Configure the **Localized Case Assessment** layout:
1. In Admin, go to **Configuration > Objects > Localized Case Assessment > Layouts > Localized Case Assessment Detail Page Layout**.
2. Insert a **Related Objects** section.
3. Complete the **Add Related Object** form with the following details:
    * **Related Object**: Localized Case Assessment Result
    * **Section Label**: Assessment Results
    * **Create Option**: Prevent Record Creation
4. Select **Done**.

## (21R2) Configure the Transmission Object

### Add the Localization lookup Field

1. In Admin, go to **Configuration > Objects > Transmission > Fields**.
2. Select **Create**.
3. Create the field with the following details:
    * **Field Type**: Lookup
    * **Label**: Localization
    * **Lookup Relationship**: Localized Case
    * **Lookup Source Field**: Localization
4. Select **Save**.
5. Go to **Transmission > Object Types**.
6. On the **Fields** view, select **Edit**.
7. Ensure the **Localization** lookup field is selected for the **Submission** object type.

### Add the Hide Localized Case layout rule to the Transmission Layout

1. In Admin, go to **Configuration > Objects > Transmission > Layouts > Submission Detail Page Layout > Layout Rules**.
2. Select **Create**.
3.  Create a Layout Rule with the following properties:
    * **Label**: Hide Localized Case
    * **Hide the Following Page Layout Items**:
        * **Type**: Fields
        * **Values**: Localized Case, Localization
    * **IF this Layout Rule Expression is TRUE:** `isblank(localized_case__vr.name__v)`
4. Select **Save**.

## (21R2) Configure the Case Product Registration Object

Secure the Case Product Registration Relationship to the Localized Case object:

1. In Admin, go to **Configuration > Objects > Case Product Registration > Fields > Localized Case**.
2. Select **Edit**.
3. Select **Secure Relationship**.
4. Select **Save**.

## (21R2) All Localized Objects (Non-Case)

If your Vault's localization object details layout has a system-related field in the **Details** section and it is not a Case child-object, insert the **System Information** section and move those fields to that section. 

Verify this configuration is done on the following objects:
* Localization
* Localized Controlled Vocabulary
* Localized Country
* Localized Dose Form
* Localized Organization
* Localized Product
* Localized Route of Administration
* Localized Study
* Localized Substance
* Localized Transmission
* Localized Unit of Measurement

### (Optional) Insert the System Information Section

1. In Admin, go to **Configuration > Objects > [Localized Object] > Layouts > [Localized Object] Detail Page Layout**.
2. Insert a **Detail Form** section.
3. Complete the section with the following properties:
   * **Section Label**: System Information
   * **Detail Form - Two Columns**
4. Select **Done**.
5. Move any system-related fields to this section.
6. Complete the section with the following properties:
   * Status
   * Created By
   * Created Date
   * Last Modified By
   * Last Modified Data
            
### (Optional) Remove Fields from the Details Section

If any of the following fields are in the **Details** section of any of the Localized Objects Detail Page Layouts, remove them from the section using the "x" next to the field:
* Lifecycle
* Lifecycle State
* Lifecycle Stage
* Lifecycle State Stage ID

## (21R2) All Localized Case Child-Objects

Certain Localized Case child object layouts may contain system-related fields in the **Details** section.

Verify this configuration is done on the following objects:
* Localized Case Cause of Death
* Localized Case Contact
* Localized Case Identifier
* Localized Case Product Substance

### (Optional) Insert the System Information Section

1. In Admin, go to **Configuration > Objects > [Localized Object] > Layouts > [Localized Object] Detail Page Layout**.
2. Insert a **Detail Form** section.
3. Complete the section with the following properties:
   * **Section Label**: System Information
   * **Detail Form - Two Columns**
4. Select **Done**.
5. Move any system-related fields to this section, including:
   * Status 
   * Created By
   * Created Date
   * Last Modified By
   * Last Modified Data
            
### (Optional) Remove Fields from the Details Section

If any of these fields appear in the **Details** section, move them to the **System Information Section**:
* Name
* Status
* Created By
* Created Date
* Last Modified By
* Last Modified Data
* Lifecycle
* Lifecycle State
* Lifecycle Stage
* Lifecycle State Stage ID

## Object Lifecycles and Workflows

### (21R2) Updates to Approved State in Localized Case Lifecycle

#### (Optional) Rename the Approved State

The 21R2 release includes a new standard Approved state for the Localized Case Lifecycle. The previously used Approved (`approved_state__c`) state can be relabelled and repurposed as a Revision state.
1. In Admin, go to **Configuration > Object Lifecycles > Localized Case Lifecycle**.
2. Select **Approved (approved_state__c)** from the **States** section. Ensure to select the custom (`__c`) state, not the standard (`__v`) Approved state.
3. Select **Edit** from the **Details** section. 
4. Enter "Revision" in the **State Label** field.
6. Select **Save**.
         
#### Configure the Approved State in the Localized Workflows

1. In Admin, go to **Configuration > Workflows**.
2. Open the following workflows for editing: 
   * Localized Case Workflow
   * Localized Case Translation Workflow
3. Select **State Change: Approved**.
4. Select **Edit**.
5. Under **State Change Options**, change the **Next State** field to the standard Approved (`approved__v`) state.
6. Select **Save**.

### (21R2) Configure the Localized Case Close Workflow

#### Create the Localized Case Close Workflow

1. In Admin, go to **Configuration > Workflows**.
2. Select **Create**.
3. Select **Object Workflow** from the drop-down menu.
4. Select **Continue**.
5. Create the workflow with the following details:
   * **Label**: Localized Case Workflow
   * **Lifecycle**: Localized Case Translation Workflow
6. Create the workflow with the following steps:
   * **Workflow Task**: Task: Case Close
   * **State Change**: State Change: Closed
7. Select **Save**.
            
#### Configure the Start Workflow: Start Workflow Step

1. Add the **Start** step.
2. Select **Add Control**.
3. Configure the **Start Options** with the following properties:
   * **Control 1**: Participants
      * **Participation Label**: Distribution Manager
      * **Add Participants**: Use roles as participants
         * **Roles allowed to participate**: Distribution Manager

#### Configure the Task: Case Close Workflow Step

1. Add a Workflow Task after the Start step, labelled **Task: Case Close** in the Localized Case Close Workflow.
2. Configure the **General Settings** with the following properties:
   * **Task Label**: Review Submissions
   * **Assign Task To**: Distribution Manager
      * Make available to users in participant group
   * **Instructions**: "Ensure localized case has been submitted to all required regulatory authorities."
   * **Task Requirement**: Required
3. Configure the Due Date:
   * **Task Creation Date**: + 1 Days
4. Select **Prompt for Verdicts** from the **Prompts** section.
5. Configure the **Verdicts** section with the following properties:
   * **Verdict Label**: Submissions Complete
   * **Capacity Label**: Signed by
      * Required
   * **Capacity Values**:
      * ICSR Approver
      * Distribution Manager<br>

### Configure the Localized Case Translation Workflow

The following configuration was originally provided in the 20R3 template:

#### Create the Localized Case Translation Workflow

1. In Admin, go to **Configuration > Workflows**.
2. Select **Create**.
3. Select **Object Workflow** from the drop-down menu.
4. Select **Continue**.
5. Create the workflow with the following details:
   * **Label**: Localized Case Translation
   * **Lifecycle**: Localized Case
6. Create the workflow with the following steps:
   * **Workflow Task**: Task: Case Close
   * **State Change**: State Change: Closed
7. Select **Save**.

#### Configure the Start Workflow: Start Workflow Step

1. Add the Start Step.
2. Select **Add Control**.
3. Configure the **Start Options** with the following properties:
   * **Control 1**: Participants
      * Participation Label: Distribution Manager
      * Add Participants: Use roles as participants
         * Roles allowed to participate: Distribution Manager, ICSR Approver
   * **Control 2**: Participants
      * Participation Label: Translators
      * Add Participants: Use roles as participants
         * Roles allowed to participate: Data Entry, Translator

#### Configure the Task: Translation Entry Workflow Step

1. Add a Workflow Task after the **State Change: Case Translation** step, labelled **Task: Translation Entry** in the Localized Case Translation Workflow.
2. Configure the **General Settings** with the following properties:
   * **Task Label**: Translation Entry
   * **Assign Task To**: Translators
      * Make available to users in participant group
   * **Instructions**: "Please ensure all necessary fields are translated."
   * **Task Requirement**: Required
3. Configure the Due Date:
   * **Task Creation Date**: + 2 Days
4. Select **Include verdicts and comments from previous tasks** from the **Notifications** section.
5. Select **Review Translation** from the **Select Tasks** drop-down menu.
6. Select **Save**.

#### Configure the Task: Review Translation Workflow Step

1. Add a Workflow Task after the **State Change: Translation Review** step, labelled **Task: Review Translation** in the Localized Case Translation Workflow.
2. Configure the **General Settings** with the following properties:
   * **Task Label**: Review Translation
   * **Assign Task To**: Approvers
      * Make available to users in participant group
   * **Instructions**: "Please ensure all necessary fields are translated."
   * **Task Requirement**: Required
3. Configure the Due Date:
   * **Task Creation Date**: + 2 Days
4. Select **Prompt for Verdicts** from the **Prompts** section.
5. Create two **Verdicts** with the following properties:
   * **Verdict Label**: Approve Revision
   * **Verdict Label**: Reject Revision
      * **Prompt for Comments**: "Comments"
      * **Required**
6. Select **Save**.

#### Configure the Decision: Approve Translation Workflow Step

1. Add a Workflow Task after the **Workflow Task: Translation Review** step, labelled **Decision: Approve Translation** in the Localized Case Translation Workflow.
2. Create a **Rule** with the following properties:
   * **IF**: Task - Review: Translation - at least one label equals - Approve Translation
   * **Then**: Approved
   * **Else**:
      * **Then**: Case Translation
3. Select **Save**.
                     

### (21R2) (Optional) Configure the Localized Case Revision Workflow

#### Create the Localized Case Revision Workflow

1. In Admin, go to **Configuration > Workflows**.
2. Select **Create**.
3. Select **Object Workflow** from the drop-down menu.
4. Select **Continue**.
5. Create the workflow with the following details:
   * **Label**: Localized Case Revision
   * **Lifecycle**: Localized Case
6. Select **Save**.
7. Select **Create** from the **Workflow Steps** section.
8. Add the following workflow steps:
   1. **State Change**: State Change: Revision
   2. **Workflow Task**: Task: Revision
   3. **Workflow Task**: Task: Review
   4. **Decision**: Approved?
   5. **State Change**: State Change: Approved
9. Select **Save**.

#### Configure the Start Workflow: Start Workflow Step

1. Add the **Start** step.
2. Select **Add Control**.
3. Configure the **Start Options** with the following properties:
   * **Control 1**: Instructions
      * **Instructions**: "You are starting a translation revision. Please provide instructions to the translators."
   * **Control 2**: Date
      * **Label**: Revision Due Date
   * **Control 3**: Participants
      * **Participation Label**: Approvers
      * Add Participants: Use roles as participants
         * Roles allowed to participate: Distribution Manager, ICSR Approver
   * **Control 4**: Participants
      * Participation Label: Translators
      * Add Participants: Allow workflow initiator to select participants
         * Roles allowed to participate: Translator
         * Allow task instructions for these participants
            * Required
         * Default users from sharing settings

#### Configure the Task: Revision Workflow Step

1. Navigate to **Task: Revision** in the Localized Case Revision Workflow.
2. Select **Edit**.
3. Configure the **General Settings** with the following properties:
   * **Task Label**: Revise Translation
   * **Assign Task To**: Translators
      * Make available to users in participant group
   * **Instructions**: "Revise case translations based on instructions."
   * **Task Requirement**: Required
4. Configure the Due Date:
   * **Task Creation Date**: - 1 Days
5. Select **Prompt for Comments** from the **Prompts** section.
6. Select **Save**.

#### Configure the Task: Review Workflow Step

1. Navigate to **Task: Review** in the Localized Case Revision Workflow.
2. Select **Edit**.
3. Configure the **General Settings** with the following properties:
   * **Task Label**: Review Translation
   * **Assign Task To**: Approvers
      * Make available to users in participant group
   * **Instructions**: "Please review revised translations."
   * **Task Requirement**: Required
4. Configure the Due Date:
   * **Task Creation Date**: + 0 Days
5. Select **Prompt for Verdicts** from the **Prompts** section.
6. Create two **Verdicts** with the following properties:
   * **Verdict Label**: Approve Revision
   * **Verdict Label**: Reject Revision
      * **Prompt for Comments**: "Comments"
      * **Required**
7. Select **Save**.                 

#### Configure the Decision: Approved? Workflow Step

1. Navigate to **Decision: Approved?** in the Localized Case Revision Workflow.
2. Select **Edit**.
3. Create a **Rule** with the following properties:
   * **IF**: Task - Task: Review - at least one label equals - Reject Revision
   * **Then**: Task: Revision
   * **Else**:
      * **Then**: State Change: Approved
4. Select **Save**.

### (21R2) Configure Entry Actions and Criteria in the Localized Case Lifecycle

#### Add Entry Actions on the Approved State

1. In Admin, go to **Configuration > Object Lifecycles > Localized Case Lifecycle > Approved**.
2. Select **Edit** from the **Entry Actions** section.
3. Add the "Change related object lifecycle state" action and **Change the State to Locked** for the following objects:
   * Localized Case Adverse Events
   * Localized Case Assessment Results
   * Localized Case Assessments
   * Localized Case Causes of Death
   * Localized Case Comment
   * Localized Case Contacts
   * Localized Case Drug History
   * Localized Case Identifiers
   * Localized Case Medical History
   * Localized Case Product Dosage
   * Localized Case Product Indications
   * Localized Case Product Substances
   * Localized Case Products
   * Localized Case Test Results
   * Case Product Registration
4. Add the "Change related Document lifecycle state" action to the following:
   * **Document Reference Field**: Case Narrative
   * **State Type: Document Workflow**: Approved
5. Select **Save**.
            
#### Add Entry Actions on the Closed State

1. In Admin, go to **Configuration > Object Lifecycles > Localized Case Lifecycle > Closed**.
2. Select **Edit** from the **Entry Actions** section.
3. Add the "Change related object lifecycle state" action and **Change the State to Locked** for the following objects:
    * Localized Case Adverse Events
    * Localized Case Assessment Results
    * Localized Case Assessments
    * Localized Case Causes of Death
    * Localized Case Comment
    * Localized Case Contacts
    * Localized Case Drug History
    * Localized Case Identifiers
    * Localized Case Medical History
    * Localized Case Product Dosage
    * Localized Case Product Indications
    * Localized Case Product Substances
    * Localized Case Products
    * Localized Case Test Results
4. Add the "Change related Document lifecycle state" action to the following:
   * **Document Reference Field**: Case Narrative
   * **State Type**: Steady State
5. Select **Save**.
            
#### Add Entry Actions on the Revision State

1. In Admin, go to **Configuration > Object Lifecycles > Localized Case Lifecycle > Revision**.
2. Select **Edit** from the **Entry Actions** section.
3. Add the "Change related object lifecycle state" action and **Change the State to Locked** for the following objects:
   * Localized Case Adverse Events
   * Localized Case Assessment Results
   * Localized Case Assessments
   * Localized Case Causes of Death
   * Localized Case Comment
   * Localized Case Contacts
   * Localized Case Drug History
   * Localized Case Identifiers
   * Localized Case Medical History
   * Localized Case Product Dosage
   * Localized Case Product Indications
   * Localized Case Product Substances
   * Localized Case Products
   * Localized Case Test Results
4. Add the "Change related Document lifecycle state" action to the following:
   * **Document Reference Field**: Case Narrative
   * **State Type**: Starting State
5. Select **Save**.
            
#### Add Entry Criteria on the Closed State

1. In Admin, go to **Configuration > Object Lifecycles > Localized Case Lifecycle > Closed**.
2. Select **Edit** from the **Entry Criteria** section.
3. Add **Validate That** criteria with the following properties:
   * **State of Related Record > Transmissions > No Records Equal** to each of the following lifecycle states:
       * Pending
       * E2B ACK Rejected
       * Error
       * E2B ACK Accepted
       * MDN Received
       * Sending Attachments
       * E2B ACK Warning
       * MDN Failure
       * Ready for Submission
       * Sending ICSR
4. Select **Save**.

### (21R2) Configure Lifecycle Stage Groups for the Localized Case Lifecycle

Hide the **Localized Organization** object in Business Admin:
1. In Admin, go to **Configuration > Lifecycle Stage Groups > Localized Case Stages**.
2. Select **Create**.
3. Create the following Stage Groups:
   * Translation
   * Review
   * Submission
   * Complete

## Security and Permissions

### (21R2) Configure Atomic Security on the Localized Case Lifecycle

#### Add Atomic Relationship Security Read Permissions to the Closed and Approved States

The objects must have **Secure Relationships** enabled before you can configure the Atomic Security: Relationship permissions.

1. In Admin, go to **Configuration > Object Lifecycles > Localized Case Lifecycle > [Approved/Closed]**.
2. Select **Edit** from the **Atomic Security: Relationships** section.
3. Change Atomic Security: Relationship permissions to Read on the following objects:
   * Localized Case Adverse Events
   * Localized Case Assessment Results
   * Localized Case Assessments
   * Localized Case Causes of Death
   * Localized Case Comment
   * Localized Case Contacts
   * Localized Case Drug History
   * Localized Case Identifiers
   * Localized Case Medical History
   * Localized Case Product Dosage
   * Localized Case Product Indications
   * Localized Case Product Substances
   * Localized Case Products
   * Localized Case Test Results
   * Case Product Registration
4. Select **Save**.

#### Add Read Access to Roles in the Localized Case Objects

You must add read access to all roles in all of the Localized Case objects:
* Localized Case
* Localized Case Adverse Events
* Localized Case Assessment Results
* Localized Case Assessments
* Localized Case Causes of Death
* Localized Case Comment
* Localized Case Contacts
* Localized Case Drug History
* Localized Case Identifiers
* Localized Case Medical History
* Localized Case Product Dosage
* Localized Case Product Indications
* Localized Case Product Substances
* Localized Case Products
* Localized Case Test Results

1. In Admin, go to **Configuration > Objects > [Localized Case Object]**.
2. Select **Edit** from the **Roles** section.
3. Add **Read** permissions to all roles.

### (21R2) Configure Matching Sharing Rules

Matching Sharing Rules must be enabled on every **Localized object**, the **Transmission** object, and the **Case Product Registration** object in your Vault. The list of localization objects are:

* Localized Case
* Localized Case Adverse Events
* Localized Case Assessment Results
* Localized Case Assessments
* Localized Case Causes of Death
* Localized Case Comment
* Localized Case Contacts
* Localized Case Drug History
* Localized Case Identifiers
* Localized Case Medical History
* Localized Case Product Dosage
* Localized Case Product Indications
* Localized Case Product Substances
* Localized Case Products
* Localized Case Test Results
* Localized Controlled Vocabulary 
* Localized Country 
* Localized Dose Form 
* Localized Organization 
* Localized Product
* Localized Reason Omitted
* Localized Route of Administration
* Localized Study
* Localized Substance
* Localized Unit of Measurement
* Transmission
* Case Product Registration

#### Enable Matching Sharing Rules on All Localized Objects

To enable matching sharing rules, perform the following steps:
1. In Admin, go to **Configuration > Objects > [Object]**.
2. Select **Edit**.
3. Select **Enable Matching Sharing Rules**.
4. Select **Continue** from the prompt.
5. Select **Save**.
            
#### Create Matching Sharing Rules on All Localized Objects

1. In Admin, go to **Configuration > Objects > [Object]**.
2. Go to the **Sharing Rules** tab.
3. Select **Create** from the **Matching Sharing Rules** section.
4. Add Sharing Rules using the [table below][1].
5. For each sharing rule, configure the matching criteria to use the **Organization** (`organization__v`) field:

<a id="all-localized-objects-sharing-rules"></a>
<table>
                                 <thead>
                                    <tr>
                                       <th>Label</th>
                                       <th>Application Role</th>
                                    </tr>
                                 </thead>
                                 <tbody>
                                    <tr>
                                       <td>[Object] - Data Entry</td>
                                       <td>Data Entry</td>
                                    </tr>
                                    <tr>
                                       <td>[Object]  - Dist Manager</td>
                                       <td>Distribution Manager</td>
                                    </tr>
                                    <tr>
                                       <td>[Object]  - Translator</td>
                                       <td>Translator</td>
                                    </tr>
                                    <tr>
                                       <td>[Object]  - ICSR Approver</td>
                                       <td>ICSR Approver</td>
                                    </tr>
                                 </tbody>
    </table>
For example: Localized Case Comments - Dist Manager
                    
#### Create Matching Sharing Rules for the Localized Organization Object

1. In Admin, go to **Configuration > Objects > Localized Organization**.
2. Go to the **Sharing Rules** tab.
3. Select **Create** from the **Matching Sharing Rules** section.
4. Add Sharing Rules using the [table below][2].
5. For each sharing rule, configure the matching criteria to use the **Organization** (`organization__v`) field.
6. Select **Save**.

<a id="localized-org-sharing-rules"></a>
<table>
                                 <thead>
                                    <tr>
                                       <th>Label</th>
                                       <th>Application Role</th>
                                    </tr>
                                 </thead>
                                 <tbody>
                                    <tr>
                                       <td>Organization - Data Entry</td>
                                       <td>Data Entry</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - Distribution Manager</td>
                                       <td>Distribution Manager</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - Editor</td>
                                       <td>Editor</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - Head of Safety</td>
                                       <td>Head of Safety</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - Intake</td>
                                       <td>Intake</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - Medical Coder</td>
                                       <td>Medical Coder</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - Medical Reviewer</td>
                                       <td>Medical Reviewer</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - QC</td>
                                       <td>QC</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - Safety Operations</td>
                                       <td>Safety Operations</td>
                                    </tr>
                                    <tr>
                                       <td>Organization - Safety Writer</td>
                                       <td>Safety Writer</td>
                                    </tr>
                                 </tbody>
                              </table>

### (21R2) Configure Permissions on the Transmission Lifecycle

Hide the **Localized Organization** object in Business Admin: 
1. In Admin, go to **Configuration > Object Lifecycles > Transmission Lifecycle**.
2. Select **Add** from the **Roles** section.
3. Ensure the following roles are added:
   * Data Entry
   * Distribution Manager
   * ICSR Approver
   * Intake
   * Medical Coder
   * Medical Reviewer
   * Quality Controller
   * Safety Operations
   * Safety Writer
4. Select **Save**.

### (21R2) Configure Permissions for the Translator Role on Document Lifecycles

You must add the **Translator** role and permissions to the following document lifecycles:
* Narrative Lifecycle
* Case Generated Document Lifecycle
* Case Source Document Lifecycle

Perform the configuration described in the following sections on each of the above lifecycles.

#### Add the Translator Role

1. In Admin, go to **Configuration > Document Lifecycles > [Document Lifecycle] > Roles**.
2. Select **Create**.
3. Create the Translator role with the following properties:
   * **Label**: Translator
   * **Application Role**: Translator
4. Select **Enable Dynamic Access Control**.
5. Select **Save**.
            
#### Add the Translator Sharing Rule

1. Go to the **Sharing Rules** tab.
2. Select **Create**.
3. Create the Sharing Rule with the following properties
   * **Label**: [Document Lifecycle Name] - Translator. For example, Narrative - Translator 
   * **Rule Criteria**: Translator
      * Organization (`organization__v`)
      * Blind Protection (`blind_protection__v`)
4. Select **Save**.
            
#### Add Translator Permissions

1. In Admin, go to **Configuration > Document Lifecycles > [Document Lifecycle] > States**.
2. Select a state.
3. Go to the **Security Settings** tab.
4. Select **Edit**.
5. Configure permissions for each lifecycle state, according to the following table:
<table>
                                 <thead>
                                    <tr>
                                       <th>Lifecycle</th>
                                       <th>State</th>
                                       <th>Permissions Granted for Translator Role</th>
                                    </tr>
                                 </thead>
                                 <tbody>
                                    <tr>
                                       <td>Case Source Lifecycle</td>
                                       <td>Imported</td>
                                       <td>
                                          <ul>
                                             <li>View Document</li>
                                             <li>Edit Fields</li>
                                          </ul>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td rowspan="4" style="vertical-align: middle;">Narrative Lifecycle</td>
                                       <td>Draft</td>
                                       <td>
                                          <ul>
                                             <li>View Document</li>
                                             <li>View Content</li>
                                             <li>Download Source</li>
                                             <li>Edit Document</li>
                                          </ul>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td>Review</td>
                                       <td>
                                          <ul>
                                             <li>View Document</li>
                                             <li>View Content</li>
                                             <li>Download Source</li>
                                          </ul>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td>Approved</td>
                                       <td>
                                          <ul>
                                             <li>View Document</li>
                                             <li>View Content</li>
                                             <li>Download Source</li>
                                          </ul>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td>Closed</td>
                                       <td>
                                          <ul>
                                             <li>View Document</li>
                                             <li>View Content</li>
                                             <li>Download Source</li>
                                          </ul>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td rowspan="2" style="vertical-align: middle;">Case Generated Document Lifecycle</td>
                                       <td>Generated</td>
                                       <td>
                                          <ul>
                                             <li>View Document</li>
                                             <li>View Content</li>
                                             <li>Download Source</li>
                                          </ul>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td>Closed</td>
                                       <td>
                                          <ul>
                                             <li>View Document</li>
                                             <li>View Content</li>
                                             <li>Download Source</li>
                                          </ul>
                                       </td>
                                    </tr>
                                 </tbody>
                              </table>

## Next Steps: Agency-Specific Configuration

* <a href="/en/lr/01363/">Enable Local Fields for PMDA (Japan)</a>
* <a href="/en/lr/01399/">Enable Local Fields for MFDS (Korea)</a>
* <a href="/en/lr/01389/">Enable Local Fields for NMPA (China)</a>

[1]: #all-localized-objects-sharing-rules
[2]: #localized-org-sharing-rules