Localized Case Field Reference

Learn how to perform Localized Case data entry and use the sections and fields on the Localized Case page.

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About Localized Case Data

Vault supports entering regional data for local submissions using Localized Cases and child records. The following sections describe Localized Case fields 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. Certain fields appear for local data entry only when the Localized Case is for China, Japan, or Korea. For information about global Case fields, see Enter Case Data.

The following fields may be available:

Field	Agency	Description
Case	N/A	Reference link to the global Case. Vault automatically populates this field.
Name	N/A	The name of the Localized Case record. Vault automatically generates a record name and populates this field.
Localization	N/A	The local language for which this Localized Case is being prepared. Vault automatically populates this field with the Localization setting used to generate the Localized Case.
Global Due Date	N/A	Vault automatically populates this field using the Due Date field on the Case.
Due Date	N/A	Vault 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, on the Child Information Case you can select the Localized Case for the parent.
NMPA Report Classification	NMPA	Select the NMPA report classification type from the picklist. 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 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

Vault maps each Case Contact from a global Case to create Localized Case Contacts.

Localized Case Contact Details Section

Use the Details section of Localized Case Contacts to translate general information about the contact. Certain fields appear for local data entry only when the Localization field is set to Korea or China. For information about global Case fields, see Enter Case Data.

The following fields may be available:

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.
Use Domestic State Code	N/A	If configured by your Admin, upon initial or follow-up domestic Case creation, Vault selects the Use Domestic State Code checkbox on the primary Reporter-type Localized Case Contact.

Localized Case Contact Address Section

Use the Address section of Localized Case Contacts to translate address information about the contact.

For domestic Cases, when Country State / Province records exist, Vault maps the information to the Localized Case. If Localized Country State / Province records exist, the information appears in the local language. For information about global Case fields, see Enter Case Data.

Products Section

Vault maps each Case Product from a global Case to create Localized Case Products.

Localized Case Product Details Section

Use the Details section of Localized Case Products to translate general information about the product and enter local data. Certain fields appear for local data entry only when the Localized Case is for China, Japan, or Korea. For information about global Case fields, see Enter Case Data.

The following fields may be available:

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 the Dosages section of Localized Case Products to translate text fields from a global Case Product Dosage.

Localized Case Product Indications Section

Use the Indications section of Localized Case Products to translate text fields from a global Case Product Indication.

Localized Case Product Substances Section

Use the Substances section of Localized Case Products to translate substance information about the product and enter local data. For information about global Case fields, see Enter Case Data.

The following fields may be available:

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 a global Case includes a Case Product Device Code record, Vault creates a Localized Case Product Device Code section. When you update values on the global Case, Vault maps these changes to the Localized Case. For information about global Case fields, see Enter Case Data.

The following fields may be available:

Field	Agency	Description
Case	N/A	Reference link to the Case. Vault automatically populates this field.
Case Product	N/A	Reference link to the Case Product linked to the Device Code. Vault 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. Vault automatically populates this field.
Localized Case Product	N/A	Reference link to the Localized Case Product. Vault 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 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

Vault maps each Case Adverse Event from a global Case to create Localized Case Adverse Events. Use a Localized Case Adverse Event to translate text fields from a global Case Adverse Event.

Assessments Section

For each Case Assessment on a global Case, Vault generates a Localized Case Assessment using the available local Datasheet for the country in the Localization field. Use a Localized Case Assessment to translate text fields from a global Case Assessment.

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

The following fields may be available:

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	To map the applicable global Case Expectedness value to a Localized Case, Vault considers the Agency associated with the country of the Localized Case. If an Agency is configured to base expectedness evaluations on the Onset date of Case Adverse Events or does not specify an evaluation basis, Vault maps the Expected value from the global Study Case Assessment Expectedness record calculated based on Onset date. If an Agency is configured to base expectedness evaluations on the New Info Dates on Cases, Vault maps the Expected value from the global Study Case Assessment Expectedness record calculated based on New Info Date. If Expectedness records calculated from a Study Datasheet are not available, expectedness is evaluated using the following priority order: Local Datasheet expectedness matching the country of the Localized Case Product Core Datasheet expectedness Global Case Assessment expectedness Regardless of the evaluation basis, when Vault finds multiple overridden or manually created Expectedness records, Vault populates the Expected value from the record with the latest Last Modified Date. For more information about how Vault evaluates expectedness based on Agency settings, see Expectedness Evaluations for Clinical Trial Study Cases.
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.
Expectedness Justification	Vault populates the value from the Expectedness Justification field on the related Case Assessment Expectedness record. If your Admin has configured the Isolate Blinded Clinical Trial Information feature in your Vault, for blinded clinical trial study Cases, Vault leaves this field blank.
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 Vault used to evaluate the Expectedness of the Adverse Event.
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.

Expectedness Syncing

Vault may sync global and localized expectedness values as follows:

When you override the Expectedness or Expected (status) value on a Localized Case Assessment, Vault does not sync the update to the global Case.
When you override the Expectedness or Expected (status) value on a global Case Assessment, Vault syncs the update to the Localized Case Assessment if the Expected (status) value on the Localized Case is Auto Calculated. Vault does not sync the update if the Expected (status) value is Overridden.
If you update the Expectedness Justification value on the Expectedness record of the global Case Assessment, Vault syncs the update to the Localized Case Assessment for Localizations that do not have Localized Assessments for Case Product Registrations in the Assessment Generation field.

Assessment Result Section

Vault maps each Case Assessment Result from a global Case to create Localized Case Assessment Results. Use a Localized Case Assessment Result to translate text fields from a global Case Assessment Result.

The following fields may be available:

Field	Agency	Description
Localized Assessment Result	MFDS NMPA	Select an assessment result. Vault maps this value to the following reports and data elements: MFDS E2B(R3) > G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment NMPA E2B(R3) > G.k.9.i.2.r.CN.2 Assessment Results 评估结果
Localized Assessment Source	NMPA	Select an assessment source. A value is required if the NMPA Report Classification is Domestic Reporting Post Marketing. Vault maps this value to the G.k.9.i.2.r.CN.1 Initial Report/Marketing Licensee Evaluation Source 初始报告人/上市许可持有人评估来源 data element of NMPA E2B(R3) reports.

Causes of Death Section

Vault maps each Case Cause of Death record from a global Case to create Localized Case Cause of Death records. Use a Localized Case Cause of Death record to translate text fields from a global Case Cause of Death record.

Medical History Section

Vault maps each Case Medical History record from a global Case to create Localized Case Medical History records. Use a Localized Case Medical History record to translate text fields from a global Case Medical History record.

Drug History Section

Vault maps each Case Drug History record from a global Case to create Localized Case Drug History records. Use a Localized Case Drug History record to translate text fields from a global Case Drug History record and add a Local MPID for Localized Cases that are reportable to the MFDS.

The following fields may be available:

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

Vault maps each Case Test Result record from a global Case to create Localized Case Test Results records. Use a Localized Case Cause Test Result record to translate text fields from a global Case Test Result record.

Narrative Section

For every generated Localized Case, Vault generates a corresponding narrative document to use for the narrative translation. For more information about generated narratives, see Generate a Case Narrative.

Use the Narrative section to translate text fields, prepare the local Case narrative, and add region-specific information. For information about global Case fields, see Enter Case Data.

The following fields may be available:

Field	Agency	Description
Case Narrative	N/A	Vault 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 Generate 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.

Field

Agency

Description

Case Narrative

Vault 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 Generate a Case Narrative.

Narrative Preview

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 Localized Cases that are reportable to the MFDS. For information about global Case fields, see Enter Case Data.

The following fields may be available:

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

Vault maps each Case Reference Number record from a global Case to create Localized Case Reference Number records. Use a Localized Case Reference Number record to translate text fields from a global Case Reference Number record.

Documents Section

Use the Documents section to add and manage documents linked to the Localized Case, including the source report, narrative, attachments, literature, and other relevant documents. This section works the same way as adding documents to global and domestic Cases.

For Localized Cases linked to Literature Articles in your SafetyDocs Vault, Vault populates records for the related literature documents in this section. When generating E2B submissions for the Localized Case, if the Literature Documents field value on the Transmission is Include, Vault attaches all Literature Articles with Retransmit field values of Yes and any of the following classifications:

Literature > Literature Article > Full-Text
Literature > Literature Article > Summary

For more information on the export of Literature Documents, see E2B Documents and Attachments and Literature References.

Generate Localized Case Documents

You can quickly generate Localized Case Documents for all documents and literature articles attached to a related global Case. From the All Actions menu, select Generate Localized Case Documents. When you run this action, Vault maps all documents from the global Case with an applicable document type, including:

Case > Source > Literature
Case > Source > Attachment, unless the Attachment Type does not apply to the reporting destination
Literature > Literature Article > Summary
Literature > Literature Article > Full-Text

On each Localized Case Document record, Vault populates the global field values based on the document type. You can translate field values as needed. When multiple documents have the same name, Vault appends _n, where n is a sequential number, to the document name.

Submissions & Distributions Section

The Submissions & Distributions section contains any outbound Transmissions associated with the Localized Case. The following articles provide more information on preparing outbound Transmissions: