Sections in This Article
- About Domestic Cases
- Create a Domestic Case
- Re-generate a Domestic Case
- Prerequisites
- Set Vault Default Language
- Enter Translations
- Text Field Mapping on Case Promotion
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)
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 Safety provides a configurable Country State/Province library. During intake and case processing, users select the Country State/Province from a picklist. The system maps the domestic state codes upon E2B(R3) import and export. For more information, see Enable Domestic Case Processing for Agency Jurisdications.
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.
When the Auto-select Inbox Item Localization by Reporter Country feature is enabled, for primary Reporter-type Contacts, if the Country has a Localization record, the Localization field on the Inbox Item is automatically set based on the Reporter’s Locale. See the Country field on the Inbox Item Field Reference for more information.
Note Contact Veeva Support to consider the Inbox Item Report Type, along with the Reporter Country, to set the Localization field on the Inbox Item. See this note 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. Domestic Case Processing is completed on the Cases tab.
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:
- Enable Domestic Case Processing to process Domestic cases
Vaults created earlier than 21R2 must:
- Enable Localized Submissions and Translations Support
- Enable Local Fields for PMDA (Japan) for Japanese case processing
- Enable Local Fields for NMPA (China) for Chinese case processing
- Enable Local Fields for MFDS (Korea) for Korean case processing
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.
Note If the Default Localization field is blank, the system automatically refers to the Language field to determine the language for the picklist field values.
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.
See Create an Inbox Item Manually for more information on creating inbox items.
Note When processing Domestic Cases, Vault Safety includes dual-language entry so you can perform data entry in both the Reporter’s local language and English at the same time. By default, text fields, picklist and object fields, and adverse events are available for dual-language entry. However, your administrator can configure Localization Scope 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 set to Narrative, only the Localized Narrative is exported on the E2B file. All other fields are English only.
Manual Text Translation
You can manually translate text fields during intake. For each text field that supports dual language intake, there are two fields:
- In the first field, enter the information in the language the adverse event was reported in.
- In the second field, marked with
, 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.
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 |
| Case Contacts > Primary Reporter | State/Province | Case Contact > Reporter | State/Province |
| 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 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 | 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. The system compares the Case details against available custom narrative templates, and applies the template with the most matching details.
Comparison includes the following Case details:
- Case Type (E2B or manual)
- Organization
- Sponsor
- Report Type
- Study Type
- Study
- Blinded or Unblinded
If no custom template details match, a system-provided narrative template is applied to the Case. 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.
