Sections in This Article
- Local Language to English Intake
- Display Localized Field Labels
- Show Dual Entry Fields
- 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 22R1 (April 2022) and earlier, an admin must add the Default Localization field to the User Profile.
- For vaults originally deployed in 21R1 (April 2021) 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.
Display Localized Field Labels
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.
Configuring the above settings allows you to perform localized manual intake with Inbox Items.
Show Dual Entry Fields
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.
Note By default on Localized Inbox Items and Cases, Vault Safety displays all local dual-entry fields on Inbox Items and Cases. For each Localization record, Administrators can configure Localization Scope to limit local language entry to Narratives, Company Comments, or both. Because Inbox Items do not include Narratives or Company Comments, when Localization Scope is limited, dual-entry fields first appear after the Promote to Case user action. All other Inbox Item and Case fields are for English-language entry, as on a Global Case.
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
Any system-provided and managed picklists and object lookup fields are shown in the value selected in the Default Localization field on your User Profile. Note that custom picklists and object records 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 (