**Source URL:** https://safety.veevavault.help/en/lr/1026369/

# Set Up the Localized Business Admin Library

Safety supports capturing data in fields required by regional agencies, such as the NMPA and MFDS. To support domestic _Case_ and _Localized Case_ processing and meet reporting requirements, you can configure certain data in the _Business Admin_ library. For example, you can:

* Customize [_Localizations_][3], such as the scope of dual-language entry and whether Vault processes cases for that _Localization_ as domestic or global. 
* Configure how your Vault populates [_Localizations_ on _Inbox Items_][1].
* Add local [_Product_ and _Substance_][4] details, such as generic names, trade names, and regional identification codes.
* Manage [localized _Controlled Vocabularies_][5] to meet your business needs

There are additional configuration options available for the intake and processing of _Cases_ for Japan.

## Prerequisites

To support _Localized Case_ processing, ensure your Vault is configured for:

* Localized submissions and translation support.
* The appropriate _Product Registrations_ and _Study Registrations_.
* A _Transmission Profile_ for a _Destination_ organization with a non-global _Localization_.
* To automatically generate _Localized Cases_, reporting rules.

Depending on your business process, you may also enable:

* Extend Definition of Suspect to Drug Not Administered: Includes _Case Products_ with the _Drug Role_ of _Drug Not Administered_ when generating _Localized Case Assessments_. Otherwise, _Localized Case Assessment_ generation considers only _Case Products_ with the _Drug Role_ of _Suspect_ or _Interacting_.
* Localized Cases: Global Narrative Override on Follow-ups: Overrides localized narratives based on related global and domestic _Case_ narratives.
* Local Case Resync: Enables anytime data-syncing from a global _Case_ to all of its foreign _Localized Cases_.
* Destination-Specific Case Document Management Improvements: Offers reporting destination-specific attachment control when exporting E2B reports and fast generation of _Localized Case Documents_.

In addition to Vault language support, you can configure your Vault to connect to Amazon Translate for translation of _Case_ text fields. Depending on your business process, you can set up automatic or manual translation requests.

**Note**: When using the Auto-Translation Framework, Vault imports the translated text as received. Vault does not perform any quality checks on the content.

### Automate Inbox Item Localization {#localization}

You can configure your Vault to populate the _Localization_ field based on reporter locale:

* If users populate the _Site Reporter_ on the _Inbox Item_, Vault populates the _Localization_ based on the reporter's _Country_ and _Reporter Language_. 
* If you configure the _Enable auto-set Inbox Item Localization by Reporter Country_ setting, Vault may populate the _Localization_ based on the primary reporter's locale. For imported structured files without a specified reporter country or language, Vault attempts to detect the language based on the _Event (Reported)_, _Narrative_, _Reporter's Comments_, and _Company Comments_ values on the generated _Inbox Item_ and populates the _Localization_ field with the _Localization_ record for the detected language. If multiple _Localizations_ exist for the language, Vault leaves the field blank. If Vault cannot detect a language, and for all other scenarios, Vault references the _Reporter_ type of _Case Contact_ with a _Rank_ of _1_:
    * If the _Country_ has a related _Localization_, Vault populates the _Localization_ field based on the _Language_ of the reporter's _Country_. 
    * If the _Country_ has multiple associated _Languages_, Vault populates the _Localization_ field based on the _Reporter Language_ field of the _Case Contact_.
    * If no match exists, Vault checks for an _English_ record. 
    * If no _English_ record exists, Vault applies the first _Localization_ record in alphabetical order for that country.
* If configured by your Admin, Vault may populate the _Localization_ based on the [primary reporter's locale and the report type][2] of the _Inbox Item_.

When users promote the _Inbox Item_, Vault processes the _Case_ as domestic or global based on the [_Localization Type_][3] of the matching _Localization_.

#### Reporter Locale and Report Type Localization {#report-localization}

You can configure your Vault to populate the _Localization_ on imported _Inbox Items_ based on the primary reporter's locale and the report type of the _Inbox Item_. Vault references the _Reporter_ type of _Case Contact_ with a _Rank_ of _1_ and the _Report Type_ of the _Inbox Item_. When the _Report Type_ is _Study_, Vault also references the _Study Type_ of the associated _Study_. Vault matches _Localization_ based on _Case Type_ values as follows:

* **Blank**: Matches regardless of the _Report Type_ of the _Inbox Item_.
* **Investigational**: Matches if the _Report Type_ of the _Inbox Item_ maps to E2B code `2` (Report in Clinical Trial) and the _Study Type_ of the _Study_ maps to E2B code `1` (Clinical Trial), or _Study Type_ is blank. For example, the _Study Type_ is _Clinical Trial_.
* **Marketing**: Matches if either of the following conditions are true:
  * The _Report Type_ of the _Inbox Item_ maps to any E2B code except `2` (Report in Clinical Trial). For example, when the _Report Type_ is any value other than _Study_. 
  * The _Report Type_ of the _Inbox Item_ maps to E2B code `2` (Report in Clinical Trial) and the _Study Type_ of the _Study_ maps to any E2B code except `1`. For example, when the _Study Type_ is any value other than _Clinical Trial_.

Vault then populates the _Localization_ field based on the matching _Localization_ record:

* If one match for the primary reporter's _Country_ and _Report Type_ exists, Vault populates the field with the corresponding _Localization_ value.
* If multiple matches for the primary reporter's _Country_ and _Report Type_ exist, Vault references the _Reporter Language_ field of the _Case Contact_.
  * If _Reporter Language_ is blank, Vault checks for an _English_ record.
  * If there are still multiple matches, Vault applies the first _Localization_ record for that _Country_ or _Report Type_.
* If zero matches for the primary reporter's _Country_ and _Report Type_ exist, Vault does not populate the field.

## Manage Localizations {#local-scope}

Vault provides the ability to manage details about locales through the _Localization_ object. This includes updating the associated, country, language, and display language, along with settings for how Vault processes some case details based on the localization. To manage _Localizations_, navigate to **Business Admin > Objects > Localizations**. Additional fields are specific to the Japan _Localization_.

The following fields are available:

* **Localization Type**: Select _Global_ or _Local_. The _Localization Type_ determines whether _Inbox Items_ and _Cases_ are processed as global, domestic, or localized.
* **Localization Scope**: You can control which fields are available for dual-language domestic _Case_ processing. 
    * Leave this field blank to include all fields. 
    * Select _Narratives_, _Company Comments_, or both to limit the fields. If configured, Vault exports the localized values for only your selections in E2B formats.
* **Case Type**: You can configure _Localizations_ by _Case Type_. For example, you can configure how your Vault localizes postmarket cases for a specific country. When setting _Inbox Item_ localization, Vault considers whether the specified _Case Type_ for the _Localization_ matches the _Report Type_ of the _Inbox Item_.

## Create Localized Organizations {#local-orgs}

You can configure _Localized Organizations_ to support local reporting, such as to the MFDS, NMPA, and PMDA. You can also configure _Localized Organizations_ to support non-PMDA Japan reporting. 

1. Navigate to an existing _Organization_.
2. Expand the _Localized Organization_ section, and then select **Create**.
3. Populate the available fields, some of which appear only for certain _Localizations_.
4. Select **Save**.

### Localized Organization Fields

The following fields may appear:

| Field | Description |
| --- | --- |
| _Name_ | Enter a name for the localized organization. |
| _Localization_ | Select the localization of the organization. |
| _Official Name_ | Enter the official name of the localized organization. Vault maps this value to the _Local MAH_ field of _Cases_ for China and on reports to the PMDA. |
| _Abbreviation_ | Enter an abbreviated name for the localized organization. |
| _MFDS Health Professional Type_ | This field displays when the _Localization_ is _Korean (South Korea)_. Select a classification of the facility type of a sender or reporting health professional. Vault transmits this value in the C.3.1.KR.1 data element of MFDS E2B(R3) files. The MFDS requires a value when the sender type of the organization is _Health Professional_. |

## Add Local Product Details {#local-products}

You can add local details for products and substances. Before you can add these details, the related _Product_ must already exist. 

### Add a Localized Product

To add a _Localized Product_:

1. Navigate to **Business Admin > Objects > Products** and select the _Product_ to which you want to add the _Localized Product_. 
2. Expand the **Localized Products** section, and then select **Create**.
3. On the _Create Localized Product_ page, complete the applicable fields:
    * **Name**: Enter the local product name. This value appears as the name on _Localized Case Products_.
    * **Localization**: Select the applicable localization.
    * **Generic Name**: Enter the local generic name for the product. Vault maps this value to the _Generic Name_ field on _Localized Case Products_ for the NMPA.
    * **Trade Name**: Enter the local trade name for the product. Vault maps this value to the _Trade Name_ field on _Localized Case Products_ for the NMPA.     
4. Select **Save**.

### Add a Localized Substance {#localized-substance}

To add a _Localized Substance_:

1. Navigate to **Business Admin > Objects > Substances** and select the _Substance_ to which you want to add the _Localized Substance_. 
2. Expand the **Localizations** section, and then select **Create**.
3. On the _Create Localized Substance_ page, complete the applicable fields:
    * **Substance Name**: Enter the local substance name.
    * **Substance**: Vault populates a link to the parent _Substance_.
    * **Local Product Code**: Enter the local product code for the substance. Vault maps this value to the _Local Product Code_ field on _Localized Case Product Substance_ records. 
    * **Localization**: Select the applicable localization.
4. Select **Save**.

## Add Localized Studies {#localized-study}

You can set up _Localized Studies_ to support compliant reporting to the NMPA and MFDS. To add a _Localized Study_ to an existing _Study_:

1. Navigate to **Business Admin > Objects > Studies > [Study]**.
2. Expand the **Localizations** section, and then select **Create**.
3. On the _Create Localized Study_ page, complete the applicable fields:
    * **Localization**: Select the applicable localization.
    * **Study Name**: Enter the local study name. Vault maps this value to the C.5.2 data element of NMPA E2B(R3) files.
    * **Study Type**: Vault populates this field based on the parent _Study_.
    * **Localized Study Number**: Enter the local study number. Vault maps this value to the C.5.3 data element of MFDS E2B(R3) files.
    * **MFDS Other Study Type**: Select the MFDS study type. Vault maps this value to the _MFDS Other Study Type_ field on Korea _Localized Cases_ with a _Study Type_ of _Other Study_.
4. Select **Save**.

### Add Local Study Registrations

To support local reporting, you can add _Study Registrations_ for each country the study is registered in.

## Local Controlled Vocabularies {#local-cv}

Vault includes _Controlled Vocabularies_ that contain standard ICH-based terminologies used to describe or code information on a _Case_. Some _Controlled Vocabulary_ types are specific to Japan. Other local _Controlled Vocabularies_ include:

* _Action Taken_
* _Case Assessment Method_
* _Case Assessment Result_
* _Drug Role_
* _Localized Case Assessment Result_
* _Localized Case Assessment Source_
* _MFDS Health Professional Type_
* _MFDS Other Health Professional Type_
* _MFDS Other Study Type_
* _NMPA Patient Nationality Code_
* _NMPA Report Source_
* _NMPA Report Classification_
* _NMPA Race_
* _Outcome_

### Add Localized Controlled Vocabularies

You can add _Localized Controlled Vocabulary_ values that correspond to _Controlled Vocabulary_ values. When generating E2B reports for that _Localization_, Vault maps the local name. To add a _Localized Controlled Vocabulary_:

1. Navigate to **Business Admin > Objects > Localized Controlled Vocabularies**.
2. Select **Create**.
3. Complete the following fields:
    * **Name**: Enter a name for the local _Controlled Vocabulary_ value.
    * **Controlled Vocabulary**: Select the corresponding _Controlled Vocabulary_ value. Based on your selection, Vault populates the _Controlled Vocabulary_ type in the _Type_ field.
    * **Localization**: Select the applicable localization.
3. Select **Save**. 

[1]: #localization
[2]: #report-localization
[3]: #local-scope
[4]: #local-products
[5]: #local-cv