Perform Local Language Intake

Through the Inbox Item, you can perform case intake in the native language a report was received in while translating to English.

Sections in This Article

Local Language to English Intake

Vault Safety supports dual language intake for entering cases that are received in a non-English language but require reporting in English. This article covers this intake scenario only. For localized (non-English) submissions, see Prepare a Localized Case.

When you promote an Inbox Item with local data to a Case, the system generates a Case in the local language. The system maps the relevant field values to the Cases.

For example, the EMA requires ICSR submissions in English. If an adverse event that occurred in Germany is reported in German. Vault Safety intake users can enter data in the source language (German) while entering the corresponding English translations in the text fields on the Inbox Item. When the Inbox Item is promoted to a Case, the system maps the data to create a Global Case which can be used for English Submissions.

Note This feature is available for intake using the Inbox Item object only. This feature is not available for AER intake.

Prerequisites

Language Display Settings

To make dual language data entry available, the Localization field must be set to the source language on the Inbox Item. Additionally, users can set the Language and Locale fields in their user profile to translate field labels and help text.

Show Dual Entry Fields and Localized Field Values

When an Inbox Item has the Localization field set to a non-global language, you can perform local language to English translation:

  1. Set the Localization field to the language the adverse event was reported in.
    The Localization field is typically in the Organization and Region section.
  2. Save the Inbox Item.

Result

After saving the Inbox Item with the Localization field, local intake fields are available.

Display Localized Field Labels

To show field labels and help text in your local language, set the Language and Locale fields in your User Profile.

Language and Locale Settings on User Profile
Language and Locale Settings on User Profile

Local Intake Fields with English Translations

The following sections provide more information on how information is translated during intake:

For descriptions of Inbox Item fields see, Inbox Item Field Reference.

Translate Text Fields

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.
Dual Language Entry Text Field
Dual Language Entry Text Field

Text Field Mapping on Case Promotion

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.

Picklist and Object Field Translations

For any system-provided and managed picklists and object lookup fields, values are shown in the locale selected in the Localization field, but automatically mapped to English on case promotion. Note that custom picklist and objects will not be automatically translated.

  • Controlled Vocabularies
  • Route of Administrations
  • Dose Forms
  • Units of Measurement
  • Reasons Omitted

Event MedDRA Translations

The Event field for Adverse Events contains an extended MedDRA control that can automatically translate coded MedDRA terms from the language selected in the Localization field to English.

If you set the Localization field to a specific language on the Inbox Item, that language is automatically selected as the MedDRA control language in the Medical Events section and Product section.

If a term cannot be coded, you can use the English field to manually enter the English translation of the reported term. See a Code Multilingual MedDRA Terms for more information.

MedDRA Translation Field
MedDRA Translation Field

Event Field Mapping on Case Promotion

For Case Adverse Events, the system maps the event as it was reported in the local language, the MedDRA code, and the English translation. However, the LLT term is always displayed in English on the promoted Case because Cases are processed in English.

The following image and corresponding table provides this mapping:

Case Adverse Event Local Intake Mapping
Case Adverse Event Local Intake Mapping
Reference Inbox Item Field Case Field
1 Event Event (Reported) (event_reported__v)
2 English Event (Reported) - English (event_reported_english__v)
3 MedDRA Code Event MedDRA (event_meddra__v)
N/A MedDRA Language Event (Reported) - Language (event_reported_language_v)

Import an Inbox Item from an E2B File
Inbox Item Field Reference
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