Sections in This Article
- Local Language to English Intake
- Language Display Settings
- Local Intake Fields with English Translations
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.
- For vaults originally deployed in 21R1 or earlier, an admin must Enable Local Language to English Intake.
- You must create an Inbox Item manually to be able to enter translations. See Create an Inbox Item Manually for instructions.
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:
- Set the Localization field to the language the adverse event was reported in.
The Localization field is typically in the Organization and Region section.
- Save the Inbox Item.
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.
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:
- 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.
Text Field Mapping on Case Promotion
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:
|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 field to manually enter the English translation of the reported term. See a Code Multilingual MedDRA Terms for more information.
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:
|Reference||Inbox Item Field||Case Field|
|Event||Event (Reported) (
|Event (Reported) - English (
|MedDRA Code||Event MedDRA (
|N/A||MedDRA Language||Event (Reported) - Language (