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:

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:

Depending on your business process, you may also enable:

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.

Automate Inbox Item 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 of the Inbox Item.

When users promote the Inbox Item, Vault processes the Case as domestic or global based on the Localization Type of the matching Localization.

Reporter Locale and Report Type 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

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

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

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

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

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

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.
  4. Select Save.