Prepare a Domestic Case

Learn how to process Domestic Cases with region-specific data in the reported language.

Sections in This Article

About Domestic Cases

Vault Safety 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 Localized Cases.

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

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

Create a Domestic Case

Vault Safety automatically generates a Domestic Case once you promote an Inbox Item with the Localization field set to a non-English value. See Perform Local Language Intake for more information.

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 Case processing lifecycle.

Re-generate 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 Actions menu on a Localized Case.

Note This action will generate all child records or any child records that have been deleted

Prerequisites

Vaults created earlier than 21R3 must:

Vaults created earlier than 21R2 must:

Set Vault Default Language

You can view and process Cases in Vault in your preferred language by selecting a language from your user profile. When you change this setting, all labels in Vault will change to the selected language. The Default Localization field determines the language in Object Reference fields, such as Report Type.

To change your Vault language:

  1. Select User Profile from the user section in the top right of Vault.
  2. Select download-doc.
  3. Select your preferred language from the Language field.
  4. Select a value from the Default Localization field.
  5. Select Save.
The Default Localization and Language Field on the User Profile
The Default Localization and Language Field on the User Profile

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.

The Localization Field
The Localization Field
The Reporter Section with Japanese Text Entered
The Reporter Section with Japanese Text Entered

See Create an Inbox Item Manually for more information on creating inbox items.

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 second field, marked with English, enter the English translation.

Code Multilingual MedDRA Terms

You can enter MedDRA terms in the reported language of the Case. The system will automatically determine and select a language from the dropdown menu next to the Auto-code button.

When you select Auto-code with a valid MedDRA term in any of the supported languages, Vault will automatically translate the MedDRA code into English below the MedDRA field.

See Code Multilingual MedDRA Terms for more information on coding MedDRA terms in non-English languages.

The Localized MedDRA Term Coded
The Localized MedDRA Term Coded

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 Safety maps Inbox Item local text fields to the local text fields on the Domestic Case:

Inbox Item Domestic Case
Section Field Object Field
Details > Awareness Details Reporter’s Comments (Native) Localized Case (Narrative) Reporter's Comments
Details > Awareness Details< Reporter’s Comments (English) Case Version (Narrative) Reporter's Comments<
Case Contacts > Contact Additional Information (Native) Localized Case Contact Additional Information
Case Contacts > Contact Additional Information (English) Case Contact Additional Information
Case Contacts > Contact Organization (Native) Localized Case Contact Organization
Case Contacts > Contact Organization (English) Case Contact Organization
Case Contacts > Contact Department (Native) Localized Case Contact Department
Case Contacts > Contact Department (English) Case Contact Department
Product Product (Native) Localized Case Product Product (Reported)
Product Product (English) Case Product Product (Reported)
Product Indication (Native) Localized Case Product Indication Name (Reported)
Product Indication (English) Case Product Indication Name (Reported)
Product > Case Product > Dosage Dose Text (Native) Localized Case Product Dosage Dose Text
Product > Case Product > Dosage Dose Text (English) Case Product Dosage Dose Text
Medical Events > Medical history & Concurrent Conditions Event (Native) Localized Case Medical History Name (Reported)
Medical Events > Medical history & Concurrent Conditions Event (English) Case Medical History Name (Reported)

English Field Translation Mapping

On Case promotion, only the English 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 Safety maps text fields with local and English values on Case promotion:

Inbox Item Case
Section English Field Object Field
Details Reporter Comments Case (Narrative) Reporters Comments
Case Contact Additional Information Case Contact Additional Information
Case Contact Organization Case Contact Organization
Case Contact Department Case Contact Department
Product Product (Reported) Case Product Product (Reported)
Product > Dosage Dose Form (Custom)* Case Product Dosage Dose Form
Product > Dosage Patient RoA (Custom)* Case Product Dosage Patient RoA
Product > Dosage Dose Text Case Product Dosage Dose Text
*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.

About the Local Narrative Preview

When you promote an Inbox Item to a Domestic Case, the system generates a localized and English Narrative document. For non-E2B imports, the Narrative documents will be blank by default.

You can edit the system-generated Narrative document or upload another document to replace the Narrative text. The local Narrative document and the English document are also linked in this section.

Note You cannot edit either of the Narrative previews at the Case-level.

The Narrative Section of a Japanese Localized Case
The Narrative Section of a Japanese Localized Case

Approve a Case
Revise an Approved Case
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