# Prepare a Domestic Case

Vault supports Case processing for Domestic Cases. Domestic Case processing provides region-specific fields and dual-language fields for entering data in a non-English language on a Case.

A Domestic Case is for cases that must be reported to the same jurisdiction where the adverse event occurred, in the local, non-English language. If a product involved in a Domestic Case has a registration to an English-reporting country (such as the FDA and EMA), you can enter English translations on the Domestic Case.

Using a Domestic Case, you can perform data entry in the local language the report was received in, while translating to English. This is a different workflow from localizing a Global (English) Case to a different language, which is through <a href="/en/gr/01290/">Localized Cases</a>.

Domestic Cases support region-specific fields for the following agencies:

* PMDA (Japan)
* NMPA (China)
* MFDS (Korea)

For information on region-specific fields for reporting to the PMDA, see <a href="/en/gr/696910/#data-capture">Complete Intake and Process Cases for the PMDA</a>.

## Prerequisites

For Vaults created earlier than 21R3, Admins must <a href="/en/gr/01330/">Enable Domestic Case Processing</a> to process Domestic Cases.

For Vaults created earlier than 21R2, Admins must complete the following configuration:

* <a href="/en/gr/01358/">Enable Localized Submissions and Translations Support</a>
* <a href="/en/gr/01389/">Enable Local Fields for NMPA (China)</a> for Chinese case processing
* <a href="/en/gr/01399/">Enable Local Fields for MFDS (Korea)</a> for Korean case processing

To include Case Products with the Drug Role of Drug Not Administered when generating Assessments, your Admin must have enabled <a href="/en/gr/01294/">Extend Definition of Suspect to Drug Not Administered</a>. Otherwise, Assessment generation considers only Case Products with the Suspect or Interacting Drug Role.

## Create a Domestic Case

Vault generates a Domestic _Case_ after you promote an _Inbox Item_ with the _Localization_ field set to a non-English value. See <a href="/en/gr/01137/">Perform Local Language Intake</a> for more information.

You can also create a Follow-up Domestic _Case_ from a _Global_ type _Inbox Item_ or merge a _Global_ type _Inbox Item_ to an In-flight Domestic _Case_. See <a href="/en/gr/826980/#localization">Perform Inbox Item to Case Compare</a> for more information.

If your Admin has configured the _Auto-set Inbox Item Localization by Reporter Country_ setting, for primary Reporter-type Contacts, if the Country has a **Localization** record, Vault populates the <a href="/en/gr/760903/#localization">_Localization_</a> field on the Inbox Item based on the Reporter's locale. When configured by your Admin, Vault sets <a href="/en/gr/760903/#localization">_Localization_</a> using both the Primary Reporter Country and Report Type.

After promoting an Inbox Item (created through Intake in a non-English language) to a Domestic Case, you can view and process Domestic Cases entirely in the reported language from the Data Entry through to the Medical Review stage of the <a href="/en/gr/01171/">Case processing lifecycle</a>. Domestic Case Processing is completed on the Cases tab.

## Regenerate a Domestic Case

If a domestic _Case_ did not successfully generate after promoting an _Inbox Item_, you can use the _Re-generate Domestic Case_ action to trigger domestic _Case_ generation. This action is available from the **All Actions** menu on _Localized Cases_.

The _Re-generate Domestic Case_ action generates all child records or any child records that have been deleted. For example, if the domestic _Case_ includes _Parent Information_, Vault generates both a domestic _Localized Case_ and domestic _Localized Parent Information_.

## Set Vault Default Language

You can view fields in Vault in your preferred language by selecting a language from your User Profile. When you change this setting, all field labels and picklist values in Vault will display in the selected language. The **Default Localization** field determines the language in Object Reference fields, such as Report Type.

<a href="https://platform.veevavault.help/assets/images/saf-default-localization-field.png" data-lightbox="saf-default-localization-field.png" data-title="" data-alt="The Default Localization and Language Fields on the User Profile">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-default-localization-field.png" alt="The Default Localization and Language Fields on the User Profile" style=""  />
</a>

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: If the <strong>Default Localization</strong> field is blank, Vault automatically refers to the <strong>Language</strong> field to determine the language for the picklist field values.</p>
    </div>
  </div>
</div>



## Enter Translations

When an Inbox Item is created through Intake in a non-English language with the **Localization** field set to a non-global value, you can enter Inbox Item data in the reported language for all sections of the Inbox Item. 

<a href="https://platform.veevavault.help/assets/images/saf-inbox-localization-field.png" data-lightbox="saf-inbox-localization-field.png" data-title="The Localization Field" data-alt="The Localization Field">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-inbox-localization-field.png" alt="The Localization Field" style="max-width: 60%;"  />
</a>

<a href="https://platform.veevavault.help/assets/images/saf-jp-reporter.png" data-lightbox="saf-jp-reporter.png" data-title="The Reporter Section with Japanese Text Entered" data-alt="The Reporter Section with Japanese Text Entered">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-jp-reporter.png" alt="The Reporter Section with Japanese Text Entered" style=""  />
</a>

See <a href="/en/gr/01133/">Create an Inbox Item Manually</a> for more information on creating inbox items.

## Localization Scope

When processing domestic _Cases_, Vault includes dual-entry fields so you can perform data entry in both the reporter's local language and English at the same time. By default, text, picklist, and object fields are available for dual-language entry. However, your Admin can configure <a href="/en/gr/01194/#local-scope">_Localization Scope_</a> to limit dual-language entry to _Narratives_, _Company Comments_, or both.

E2B file export respects the _Localization Scope_ setting. For example, if the _Localization Scope_ is _Narrative_, only the localized narrative content is exported on E2B files. All other fields are English only.

Vault also considers _Localization Scope_ before generating _Parent Information_ for domestic _Cases_. If the _Localization Scope_ is _Narratives_, _Company Comments_, or both, Vault does not generate domestic _Parent Information_.

### Manual Text Translation

You can manually translate text fields during intake. For each text field that supports dual language intake, there are two fields:
1. In the first field, enter the information in the language the adverse event was reported in.
2. In the **English** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-dual-language-local-intake-english-field-label.png" alt="English" style=" width: 4rem;" />) field, enter the English translation.

### Code Multilingual MedDRA Terms

You can enter MedDRA terms in the reported language of the Case. For more information about how to code multilingual MedDRA terms, see <a href="/en/gr/01164/">Code MedDRA Terms</a>. 

## Domestic State Code Mapping {#domestic-state-code}

For domestic _Cases_ originating in a country, such as Spain or Italy, where the state code is required in submissions to a specific agency, such as the EMA, Vault provides a configurable _Country State/Province_ library with _Domestic State Codes_. If <a href="/en/gr/740208/#domestic-cases">configured</a> by your Admin, upon initial or follow-up domestic _Case_ creation, Vault selects the _Use Domestic State Code_ checkbox on the primary <em>Reporter</em>-type _Localized Case Contact_. This includes when a follow-up domestic _Inbox Item_ is merged into or promoted to a follow-up for an initial global _Case_. When the _Use Domestic State Code_ checkbox is selected, during E2B(R3) import and export, Vault attempts to map the _State/Province_ value on the _Case Contact_ to a _Country State/Province_ record.

On import, Vault selects the _Use Domestic State Code_ checkbox on the primary <em>Reporter</em>-type _Localized Case Contact_ and clears the value in the _State/Province_ field.

On export, Vault populates the <a href="/en/gr/700007/#mapping-logic-state-province">C.2.r.2.5 Reporter's State or Province</a> data element on EMA E2B(R3) files as follows:

* For countries within the jurisdiction of the EMA:
    * For primary <em>Reporter</em>-type _Case Contacts_ on global _Cases_ and primary <em>Reporter</em>-type _Localized Case Contacts_ on _Localized Cases_ with the _Use Domestic State Code_ checkbox selected, Vault maps the _State/Province_ to a _Country State/Province_ record. If the record includes a _Domestic State Code_, Vault exports the code. Otherwise, Vault exports the _Name_ of the _Country State/Province_ record.
    * For non-primary <em>Reporter</em>-type _Case Contacts_ on global _Cases_ and non-primary <em>Reporter</em>-type _Localized Case Contacts_ on _Localized Cases_ with the _Use Domestic State Code_ checkbox selected, Vault exports the _Name_ of the _Country State/Province_ record. 
* For countries outside the jurisdiction of the EMA:
    * For all primary and non-primary <em>Reporter</em>-type _Case Contacts_ on global _Cases_ and <em>Reporter</em>-type _Localized Case Contacts_ on _Localized Cases_ with the _Use Domestic State Code_ checkbox selected, Vault exports the _Name_ of the _Country State/Province_ record. 

In all of the above scenarios, if a _Country State/Province_ record is not available or the _Use Domestic State Code_ checkbox on the _Localized Case Contact_ is clear, Vault exports the _State/Province_ value on the _Case Contact_ or _Localized Case Contact_.

## Text Field Mapping on Case Promotion

When a Domestic Case is created upon Case promotion, the Inbox Item local text fields (that have data entered in their native language) are mapped to the corresponding local text fields on the Domestic Case in the same language.

The following table describes how Vault maps Inbox Item local text fields to the local text fields on the Domestic Case:

<table>
    <thead>
        <tr>
            <th colspan="2">Inbox Item</th>
            <th colspan="2">Domestic Case</th>
        </tr>
        <tr>
            <th>Section</th>
            <th>Field</th>
            <th>Object</th>
            <th>Field</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Awareness Details</td>
            <td>Reporter's Comments (Native)</td>
            <td>Localized Case</td>
            <td>Reporter's Comments</td>
        </tr>
        <tr>
            <td>Awareness Details</td>
            <td>Reporter's Comments (English)</td>
            <td>Case Version</td>
            <td>Reporter's Comments</td>
        </tr>
        <tr>
            <td>Contacts > Contact</td>
            <td>Additional Information (Native)</td>
            <td>Localized Case Contact</td>
            <td>Additional Information</td>
        </tr>
        <tr>
            <td>Contacts > Contact</td>
            <td>Additional Information (English)</td>
            <td>Case Contact</td>
            <td>Additional Information</td>
        </tr>
        <tr>
            <td>Contacts > Contact</td>
            <td>Organization (Native)</td>
            <td>Localized Case Contact</td>
            <td>Organization</td>
        </tr>
        <tr>
            <td>Contacts > Contact</td>
            <td>Organization (English)</td>
            <td>Case Contact</td>
            <td>Organization</td>
        </tr>
        <tr>
            <td>Contacts > Contact</td>
            <td>Department (Native)</td>
            <td>Localized Case Contact</td>
            <td>Department</td>
        </tr>
        <tr>
            <td>Contacts > Contact</td>
            <td>Department (English)</td>
            <td>Case Contact</td>
            <td>Department</td>
        </tr>
        <tr>
            <td>Contacts > Reporter (primary)</td>
            <td>State/Province</td>
            <td>Case Contact > Reporter </td>
            <td>State/Province</td>
        </tr>
        <tr>
            <td>Products > Case Product</td>
            <td>Product (Native)</td>
            <td>Localized Case Product</td>
            <td>Product (Reported)</td>
        </tr>
        <tr>
            <td>Products > Case Product</td>
            <td>Product (English)</td>
            <td>Case Product</td>
            <td>Product (Reported)</td>
        </tr>
        <tr>
            <td>Products > Case Product</td>
            <td>Indication (Native)</td>
            <td>Localized Case Product Indication</td>
            <td>Name (Reported)</td>
        </tr>
        <tr>
            <td>Products > Case Product</td>
            <td>Indication (English)</td>
            <td>Case Product Indication</td>
            <td>Name (Reported)</td>
        </tr>
        <tr>
            <td>Products > Case Product > Dosage</td>
            <td>Dose Text (Native)</td>
            <td>Localized Case Product Dosage</td>
            <td>Dose Text</td>
        </tr>
        <tr>
            <td>Products > Case Product > Dosage</td>
            <td>Dose Text (English)</td>
            <td>Case Product Dosage</td>
            <td>Dose Text</td>
        </tr>
        <tr>
            <td>Events > Medical Event > Medical History & Concurrent Conditions</td>
            <td>Event (Native)</td>
            <td>Localized Case Medical History</td>
            <td>Name (Reported)</td>
        </tr>
        <tr>
            <td>Events > Medical Event > Medical History & Concurrent Conditions</td>
            <td>Event (English)</td>
            <td>Case Medical History</td>
            <td>Name (Reported)</td>
        </tr>
    </tbody>
</table>

### English Field Translation Mapping

On Case promotion, only the <img class="inline" src="https://platform.veevavault.help/assets/images/saf-dual-language-local-intake-english-field-label.png" alt="English" style=" width: 3rem;" /> field translations are mapped to the Global Case. The field values in the local language are not copied over to the Global Case.

The following table describes how Vault maps text fields with local and English values on Case promotion:

<table>
    <thead>
        <tr>
            <th colspan="2">Inbox Item</th>
            <th colspan="2">Case</th>
        </tr>
        <tr>
            <th>Section</th>
            <th><img class="inline" src="https://platform.veevavault.help/assets/images/saf-dual-language-local-intake-english-field-label.png" alt="English" style=" width: 2.75rem;" /> Field</th>
            <th>Object</th>
            <th>Field</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Details</td>
            <td>Reporter Comments</td>
            <td>Case (Narrative)</td>
            <td>Reporters Comments</td>
        </tr>
        <tr>
            <td>Case Contact</td>
            <td>Additional Information</td>
            <td>Case Contact</td>
            <td>Additional Information</td>
        </tr>
        <tr>
            <td>Case Contact</td>
            <td>Organization</td>
            <td>Case Contact</td>
            <td>Organization</td>
        </tr>
        <tr>
            <td>Case Contact</td>
            <td>Department</td>
            <td>Case Contact</td>
            <td>Department</td>
        </tr>
        <tr>
            <td>Product</td>
            <td>Product (Reported)</td>
            <td>Case Product</td>
            <td>Product (Reported)</td>
        </tr>
        <tr>
            <td>Product > Dosage</td>
            <td>Dose Form (Custom)*</td>
            <td>Case Product Dosage</td>
            <td>Dose Form</td>
        </tr>
        <tr>
            <td>Product > Dosage</td>
            <td>Patient RoA (Custom)*</td>
            <td>Case Product Dosage</td>
            <td>Patient RoA</td>
        </tr>
        <tr>
            <td>Product > Dosage</td>
            <td>Dose Text</td>
            <td>Case Product Dosage</td>
            <td>Dose Text</td>
        </tr>
    </tbody>
    <tfoot>
        <tr>
            <td colspan="4">*Text translations are only available when entering custom Dose Forms or Patient RoAs. Translations for standard system-provided Dose Forms and Patient RoA values are automatically mapped upon Case promotion.</td>
        </tr>
    </tfoot>
</table>

### About the Local Narrative Preview

When you promote an Inbox Item to a domestic Case, Vault generates a localized and English narrative document based on your Admin's configuration, which you can review and access in the _Narrative_ section. You can edit the generated narrative document or upload another document to replace the generated narrative. For more information, see <a href="/en/gr/01167/">Generate a Case Narrative</a>.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: You cannot edit the narrative previews in this section.</p>
    </div>
  </div>
</div>



<a href="https://platform.veevavault.help/assets/images/saf-domestic-narrative.png" data-lightbox="saf-domestic-narrative.png" data-title="The Narrative Section of a Japanese Localized Case" data-alt="The Narrative Section of a Japanese Localized Case">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-domestic-narrative.png" alt="The Narrative Section of a Japanese Localized Case" style="width: 50%;"  />
</a>

### PMDA-Specific Sections

The following related sections are available only for processing Cases that may be reportable to the PMDA:

* Case Product Registrations
* Local Reporting Details
* PMDA Reportable Products
* Case Comments

For information on these sections, see <a href="/en/gr/696910/#cpr-section">Complete Intake and Process Cases for the PMDA</a>.