Prepare a Localized Case

Vault Safety supports Case translations to meet local submission requirements.

About Localized Cases

Localized Cases are automatically generated based on local submission requirements.

When a Submission or Distribution is created for a Destination Organization with the Localization field set to a non-global value, Vault generates a Localized Case for the appropriate locale.

When the Auto-select Inbox Item Localization by Reporter Country feature is enabled, for primary Reporter-type Contacts, if the Reporter Country has a Localization record, the Localization field on the Inbox Item is automatically populated. When the Inbox Item is promoted to a Case, it is processed as a Domestic Case and a Localized Case is generated. For more information, see Prepare a Domestic Case.

As part of the process for generating a Localized Case, Vault also generates localized versions of several Case child objects. Localized Case is the root of all localized records, additional Localized Case child records are generated and linked.

If your Admin has configured your Vault to isolate blinded Product information on Clinical Trial Study Cases, see Isolate Blinded Clinical Trial Information for additional considerations during Localized Case processing.

Important Terms

• Global: Global refers to the main operating language of an international company. English is the only language considered global.
• Locale: The locale is determined by the country and language of regional agencies that require submissions. For example, Portuguese (Brazil).
• Localized Case: A Vault object used to prepare case translations for regional submissions and distributions.

Prerequisites

In Vaults originally deployed in 21R2 or earlier, your Admin must enable localized submissions and translation support.

The following items should be set up by your Admin:

• The appropriate Product and Study Registrations.
• A Transmission Profile for a Destination Organization with a non-Global Localization setting.
• To automatically generate Localized Cases, set up Reporting Rules.

• To include Case Products with the Drug Role of Drug Not Administered when generating Localized Case Assessments, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, Localized Case Assessment generation considers only Case Products with the Suspect or Interacting Drug Role.

Auto-Translation Framework

In addition to Vault Safety language support, you can configure your Vault to connect to Amazon Translate for translation of Case text fields. Depending on your business process, you can set up automatic or manual translation requests. For more information about the required setup, see Enable the Auto-Translation Framework for Localized Case Auto-Translation for Submissions.

How Localized Cases are Generated

When a Transmission (Submission or Distribution) is created, the localization settings on the Destination Organization determine whether a Localized Case is generated and for which locale.

Localization requirements are configured using the Localization field on Organization records in the Business Admin library. When a Transmission specifies a Destination for which the Organization’s Localization field is populated, a Localized Case is generated.

For example, consider the following process illustration where a Case matched Global Transmission Profiles for the FDA and EMA, and also matched a PMDA (Japan) Transmission Profile:

If there are two transmissions with the same target language, they will reference the same Localized Case. Vault does not generate duplicate Localized Cases with the same language.

Vault checks for localization requirements for both manually and automatically generated Transmissions. To be automatically generated, the Case must trigger pre-configured reporting rules for a reporting destination.

How to Generate a Localized Case

Vault generates Localized Cases automatically when a Transmission is generated for a global Case with a non-Global Localization setting.

1. Generate a Transmission using one of the following methods:
   • Automatically: Move the Case into the Approved state or run the Evaluate Reporting Obligations action on the Case.
   • Manually: Add a Submission or Distribution.
2. Verify the Transmission meets the following criteria:
   • Destination: Specifies a destination Organization with the Localization field set to any value other than Global.
   • Transmission Document Type: Set to one of the following:
     • ICH E2B R2
     • ICH E2B R3
   • Origin and Destination: Match the Transmission Profile.

Result

Vault automatically generates Localized Cases for the target languages required for submissions.

Evaluate Reporting Obligations for Localized Transmissions

The Evaluate Reporting Obligation action is used to review the reporting requirements to the local Case’s agency and re-calculate the due date once local Case processing has been completed.

The Evaluate Reporting Obligations action is available from the All Actions menu on Localized Cases.

When you use this action, Vault searches for a matching reporting rule. Vault then regenerates and validates Submissions with the following conditions:

If Vault finds a matching reporting rule:

• If there are no Localized Cases in an In Progress state, Vault creates a new Transmission.

OR

• If there are Localized Cases in an In Progress state, the Transmission field values of the Cases are updated with the parameters of the matched reporting rule.

If Vault does not find a matching reporting rule, Vault gathers all existing In Progress Transmission records related to the Localized Cases and moves them to the Withdrawn state.

An In Progress Transmission refers to any Transmission in one of the following states:

• Active
• Error
• Pending
• Ready for Submission
• Ready
• Validation Error

Translating Case Data

Vault snapshots fields and child records from the global Case into the Localized Case as a starting point for conducting translations.

Note that, in the standard configuration for this feature, you cannot add child objects to a Localized Case that are not already on the global Case, such as Case Products. The only exception to this is Case Comments and Case Product Registrations.

You can then use the Localized Case to translate text fields, translate the narrative, and enter region-specific information.

Non-text fields such as Units of Measurements, picklists, and Controlled Vocabularies are automatically translated for standard supported languages.

Changes made to the Localized Case will not impact the global Case or narrative.

Narrative Translation

For every Localized Case that is generated, Vault generates a corresponding Narrative document to be used for the narrative translation. Vault populates the Localized Case Narrative document with the English narrative at the point in time when the Localized Case was generated.

When creating a Localized Follow-up Case through the Case Compare page, Vault Safety generates the Localized Narrative document based on the Inbox Item and Case Narratives. If both include a Narrative, all information is combined on the Localized Narrative document. If neither the Inbox Item nor the Case include a Narrative, the Localized Narrative document is blank.

For more information on narratives, see Compose a Case Narrative.

Supported Languages and Locales

Vault Safety supports a number of languages by default. See About Supported Languages for the list of standard supported languages.

Locale is determined using a combination of language and country. English is the only language considered global. All other languages generate Localized Case records.

Vault Safety supports generating Localized Cases for many standard languages. If you require additional languages for translations, your administrator can update your Vault configuration to support additional locales.

Send Translation Requests Through the Auto-Translation Framework

If your organization has set up the Auto-Translation Framework, you can send Localized Case text fields to Amazon Translate for translation.

The Auto-Translation Framework can be set up as follows:

• Automated Translation Requests: Translation requests are sent automatically when Localized Cases are generated.
• Manual Translation Requests: Translation requests are sent manually after Localized Case creation. Select the All Actions menu, and then select Translate Localized Case.

For both automated and manual translation requests, after Vault Safety sends the translation request, the Localized Case enters the Translation Requested state.

When third-party translations are generated and returned to Vault Safety, they are automatically applied to the Localized Case. Vault does not verify the quality of the translation, but simply imports it. The Localized Case enters the Translation Verification state.

Considerations for Translation Requests

• Localized Cases in the Translation Requested state are editable. If text fields are edited in this state, the updated values are overridden when translations are returned to Vault Safety.
• If the length of the translated text exceeds the character limit of any text field, the text is truncated to that field’s maximum length. Vault displays a notification message indicating which fields have been truncated.
• The translation must be returned within 60 minutes or the task will expire. Vault displays a notification message for failed translation requests.

Generate Localized Case Transmission Documents

Once translations have been entered into a Localized Case, go to the Transmission and use the Generate Transmission Document(s) action.

For more information, see Manually Generate a Submittable Report.

Manage Localized Follow-Up Cases

When a Follow-up Case is created with the Localization type set to Local, a Domestic Localized Follow-up Case is generated. All of the related Localized field data and Localized Case records, including foreign Localized Case records, are copied from the previous version to the Domestic Localized Follow-up Case. If the Follow-up Case is created from an Inbox Item, new data from the Inbox Item is merged into the Domestic Localized Follow-up Case. For more information, see the Localized Data section under Default Merge Behavior.

Because Localized Follow-up Cases are automatically generated when the global Follow-up Case is created, Vault does not allow edits to Localized Follow-up Cases until the associated global Follow-up Case has a Transmission record. This prevents starting translations before all the information from the global Case has been entered.

Foreign Localized Case Syncing

When a global Follow-Up Case is automatically or manually transmitted, Vault performs a one-time data sync from the global Case to the Localized Case, as follows:

• New and edited records from the global Follow-Up Case are copied to the Localized Case
• Deleted records and fields on the global Follow-Up Case are deleted from the Localized Follow-Up Case
• Populated text fields on the Localized Case are copied to the Localized Follow-Up Case. If the Localized Case contains blank text fields, these fields are copied from the global Follow-Up Case to the Localized Follow-Up Case.

Translation Workflow

Refer to your organization’s standard operating procedures for details on your organization’s translation workflow.

Enter Localized Case Data

Vault Safety supports entering regional data fields for local submissions using the Localized Case object and child records. The following sections describe the fields on Localized Cases that are specific to regional submissions.

For information on entering Localized Case Data when reporting to the PMDA, see Complete Intake and Process Cases for the PMDA.

Details Section

Use the Details section to view information about the Localized Case being prepared. Certain fields appear for local data entry when the Localized Case is for China, Japan, or Korea.

For information on Details section fields when processing Cases for Japan, see Complete Intake and Process Cases for the PMDA.

Field	Agency	Description
Case	N/A	Reference link to the global Case. The system automatically populates this field.
Name	N/A	The name of the Localized Case record. The system automatically generates a record name and populates this field.
Localization	N/A	The local language for which this Localized Case is being prepared. The system automatically populates this field with the Localization setting used to generate the Localized Case.
Global Due Date	N/A	The system automatically populates this field using the Due Date field on the Case.
Due Date	N/A	The system populates this field with the earliest regulatory due date for the Localization. This is calculated based on the Reporting Rule Set for the applicable agency. When reporting to the PMDA, the Due Date calculation also considers the Localized Case Assessment Due Date to find the earliest date.
Localized Parent Information	NMPA MFDS	Reference to the Localized Case for the parent from the current (child) case. For a parent-child case, select the Localized Case for the parent.
NMPA Report Classification	NMPA	Select the NMPA report classification type from the drop-down menu. The following options are available by default: Domestic Report, Clinical Study Domestic Reporting Post Marketing Overseas report Clinical Study Overseas Reporting Post Marketing
CIOMS Remarks	N/A	Translate any comments or additional information that should be populated in field 26. REMARKS on the CIOMS I form. To learn more, see To learn more, see CIOMS I Generation Data Mapping.
Access Group	N/A	The Case Access Group on the associated global Case. This field does not appear on layouts by default. Depending on your organization's security configuration, it may be added by your Admin.

Contacts Section

Each Case Contact from the global Case is snapshotted to create Localized Case Contacts.

Localized Case Contact Details Section

Use the Details section to translate general information about the contact. Certain fields appear for local data entry when the Localization field is set to Korea or China.

The following table outlines the local fields available on a Localized Case Contact. For information about other fields, see the global Case field equivalents.

Field	Agency	Description
MFDS Other Health Professional Type	MFDS	Select the MFDS Other Health Professional Type from the drop-down menu. This field is only available when the Reporter Qualification is set to Other Health Professional for a Korean Domestic Case.
NMPA Report Source	NMPA	For Reporter-type Case Contacts, select the report source from the drop-down menu.
NMPA Patient Nationality	NMPA	For Patient-type Case Contacts, enter the 2-letter Chinese nationality code.
NMPA Patient Race	NMPA	For Patient-type Case Contacts, select the patient's race from the drop-down menu.

Localized Case Contact Address Section

Use the Address section to translate contact information.

For Domestic Cases, when Country State / Province records exist, the information is mapped to the Localized Case. If Localized Country State / Province records exist, the information appears in the local language. For information about the other fields in this section, see the global Case field equivalents.

Products Section

Each Case Product from the global Case is snapshotted to create Localized Case Products.

Localized Case Product Details Section

Use the Details section to translate general information about the product and enter local data. Certain fields appear for local data entry when the Localized Case is for China, Japan, or Korea.

The following table outlines the local fields available on a Localized Case Product. For information about other fields, see the global Case field equivalents.

Field	Agency	Description
Local MPID	NMPA MFDS	Use this field to enter the region-specific Medicinal Product Identification (MPID) code on a Localized Case Product for an External Product. For Company Products, the Local Product Code field on Case Product Registrations should be used.
Related Device Information	NMPA	Enter the Medical Device Information that may be associated with the reported adverse event. This field corresponds to NMPA E2B data element G.k.CN.2

Localized Case Product Dosages Section

Use a Localized Case Product Dosage to translate text fields from a global Case Product Dosage. For information about these fields, see the global Case field equivalents.

Localized Case Product Indications Section

Use a Localized Case Product Indication to translate text fields from a global Case Product Indication. For information about these fields, see the global Case field equivalents.

Localized Case Product Substances Section

Use a Localized Case Product Substance to translate text fields from a global Case Product Substance and add a Local Product Code.

The following table outlines the local field available on a Localized Case Product Substance. For information about other fields, see the global Case field equivalents.

Field	Agency	Description
Local Product Code	NMPA MFDS	Enter the region-specific product code for the substance.

Localized Case Product Device Section

This section captures the harmonized FDA/IMDRF codes for device-specific adverse events.

If the global Case includes a Case Product Device Code record, a Localized Case Product Device Code section is created. When the values on the global Case are updated, these changes are synced to the Localized Case.

The following table outlines the local fields available on a Localized Case Product Device. For information about other fields, see the global Case field equivalents.

Field	Agency	Description
Case	N/A	Reference link to the Case. The system automatically populates this field.
Case Product	N/A	Reference link to the Case Product linked to the Device Code. The system automatically populates this field.
Case Product Device Code	N/A	Displays the Device Code entered on the global Case. The available options are dependent on the Device Code Type selected and the active IMDRF dictionary version.
Localized Case	N/A	Reference link to the Localized Case. The system automatically populates this field.
Localized Case Product	N/A	Reference link to the Localized Case Product. The system automatically populates this field.
Device Code Type	N/A	Displays the selected IMDRF annex name for the category of device code. This value is copied from the global Case.
Local Code	N/A	Enter the local device code. This field is blank by default.

PMDA-Specific Sections

The following related sections are available only for processing Cases that may be reportable to the PMDA:

• Case Product Registrations
• Local Reporting Details
• PMDA Reportable Products
• Case Comments

For information on these sections, see Complete Intake and Process Cases for the PMDA.

Adverse Events Section

Each Case Adverse Event from the global Case is snapshotted to create Localized Case Adverse Events.

Use a Localized Case Adverse Event to translate text fields from a global Case Adverse Event. For information about these fields, see the global Case field equivalents.

Assessments Section

For each Case Assessment on the global Case, a Localized Case Assessment is generated using the Local Datasheet for the country in the Localization field, if available.

Use a Localized Case Assessment to translate text fields from a global Case Assessment. For information about these fields, see the global Case field equivalents.

For information on Localized Case Assessments for Case Product Registrations, used for Localized Cases that are reportable to the PMDA, see Assessments Section in Complete Intake and Process Cases for the PMDA.

Field	Description
Localized Case	Reference link to the Case. Vault automatically populates this field.
Name	The name of the Localized Case Assessment record.
Case Assessment	Reference link to the Case Assessment. Vault automatically populates this field.
Expected	Whether the associated Localized Case Adverse Event is listed on the Local Datasheet associated with the suspect Case Product or associated Study. If your Admin has configured Datasheets, Vault automatically populates this field based on the expected reactions listed on the local datasheet. You can select a different option to override Vault-calculated value or to enter the value manually. If there are multiple local Datasheets, Vault calculates Expectedness as follows: For a Study Case, auto calculation is based on the Study Core Datasheet. For non-Study Cases, auto calculation is based on the most conservative assessment. If there is no local Datasheet, Vault applies the Case Assessment from the associated global Case.
Expected (status)	How the Expected field was populated, whether system-calculated or with a manual override. Vault automatically populates this field, but it can be edited.
Case Product	The Suspect, Interacting, or Drug Not Administered Case Product. For Cases reportable to the PMDA, Vault downloads all associated Products with registrations for Japan. In addition, when the Retrieve Reportable Case Product Registrations action is run, Vault downloads all Products that are reportable to Japan and have the same Substance as the Suspect, Interacting, or Drug Not Administered Case Product.
Case Product Registration	The Case Product Registration for the Case Product.
Datasheet	The Local or Core Datasheet based on which the Expectedness of the Adverse Event was evaluated.
Datasheet Document	The Company Core Data Sheet (CCDS), Investigational Brochures (IB), Development Core Safety Information (DCSI), or other document associated with the Datasheet.
Override Reason	Enter a reason for overriding Vault-calculated Expectedness.

Assessment Result Section

Each Case Assessment Result from the global Case is snapshotted to create Localized Case Assessment Results.

Use a Localized Case Assessment Result to translate text fields from a global Case Assessment Result. For information about these fields, see the global Case field equivalents.

Causes of Death Section

Each Case Cause of Death from the global Case is snapshotted to create Localized Case Cause of Death records.

Use a Localized Case Cause of Death to translate text fields from a global Case Cause of Death. For information about these fields, see the global Case field equivalents.

Medical History Section

Each Case Medical History record from the global Case is snapshotted to create Localized Case Medical History records.

Use a Localized Case Medical History to translate text fields from the global Case Medical History. For information about these fields, see the global Case field equivalents.

Drug History Section

Each Case Drug History record from the global Case is snapshotted to create Localized Case Drug History records

Use a Localized Drug History to translate text fields from the global Case Drug History and add a Local MPID for MFDS (Korea).

The following table outlines the local field available on a Localized Case Drug History. For information about other fields, see the global Case field equivalents.

Field	Agency	Description
Local MPID	MFDS	Enter the Local MPID. For South Korean submissions to MFDS, this field captures local drug codes on the Localized Case Drug History Object.

Test Results Section

Each Case Test Result record from the global Case is snapshotted to create Localized Case Test Results.

Use a Localized Case Test Result to translate text fields from a global Case Test Result. For information about these fields, see the global Case field equivalents.

Narrative Section

For every Localized Case that is generated, Vault generates a corresponding Narrative document to be used for the narrative translation. The Case Narrative and other Case text fields are snapshotted to the Narrative section on a Localized Case.

Use the Narrative section to translate text fields, prepare the local Case narrative, and add region-specific information.

The following table outlines the local fields available in the Narrative section. For information about other fields, see the global Case field equivalents.

Field	Agency	Description
Case Narrative	N/A	The system automatically populates this field with a link to the narrative document for the local language, which is generated along with the Localized Case. To open the narrative document, select the link. Any text entered on the global narrative is copied over to the local narrative to use as a starting point for translation. To learn more, see To learn more, see Compose a Case Narrative.
Narrative Preview	N/A	This field is read-only and automatically updated with a text excerpt of the local language narrative document, up to 32,000 characters. This field shows a preview of the narrative that will be populated in generated regulatory reports. To update the narrative, edit the narrative document.
Additional Pregnancy Related Information	NMPA	Enter any additional pregnancy-related information, such as history of previous pregnancy, fetus outcome, and so on.

Study Section

Use the Study section to translate text fields related to the study associated with the case and add region-specific information for MFDS (Korea).

The following table outlines the local field available in the Study section. For information about other fields, see the global Case field equivalents.

Field	Agency	Description
MFDS Other Study Type	MFDS	Select the MFDS Study Type from the drop-down menu. This field is only available when the Study Type is set to Other Study.

Reference Numbers Section

Each Case Reference Number from the global Case is snapshotted to create Localized Case Reference Numbers.

Use a Localized Case Reference Number to translate text fields from a global Case Reference Number. For information about these fields, see the global Case field equivalents.

Submissions & Distributions Section

The Submissions & Distributions section contains any outbound Transmission records associated with the Localized Case.

The following articles provide more information on preparing outbound Transmissions:

• Submissions and Distributions Overview
• Submission Generation and Linking for PMDA Localized Cases
• Create a Submission
• Create a Distribution