# Localized Case Field Reference Safety 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 Case Field Reference. The following fields may be available:
Field Agency Description
Case
  • N/A
 Vault populates a link to the global Case.
Name
  • N/A
 Vault populates a Localized Case name.
Localization
  • N/A
 Vault populates the language and country of the Localized Case.
Global Due Date
  • N/A
 Vault populates the Due Date on the global Case.
Due Date
  • N/A

Based on the Reporting Rule Set for the applicable agency, Vault populates the earliest regulatory due date for the Localization.

To find the earliest date when reporting to the PMDA, the Due Date calculation also considers the Due Date on the Localized Case Assessment.
Localized Parent Information
  • NMPA
  • MFDS
 Vault populates a link to the Localized Case for the parent from the current (child) Case. For a parent-child case, on the Child Information record you can select the Localized Case for the parent.
NMPA Report Classification
  • NMPA
 Select the NMPA report classification.
NMPA Report Source
  • NMPA
 Select the source of the report. Vault populates this value in the C.1.CN.1 data element of NMPA E2B(R3) files.
Local New Info Date/Time
  • NMPA
 Enter the latest date additional information was received about the Localized Case. Use the calendar to select the date or enter the date manually. During report generation, Vault maps this value to NMPA E2B(R3) data element C.1.5.
Local MAH
  • NMPA

Vault maps the Official Name on the Localized Organization related to the Registrant Holder/Applicant on a Product Registration for the NMPA using the following priority order:

  1. The earliest-created Product Registration of the Case Product Registration on the suspect primary Case Product
  2. The earliest-created Product Registration of the suspect primary Case Product
  3. The earliest-created Product Registration of:
    • The suspect Case Product with the next highest Rank that has a Product Registration for the NMPA
    • The earliest created suspect Case Product without a Rank
  4. The earliest-created Product Registration with a related Localized Organization that includes an Official Name
CIOMS Remarks
  • N/A
 Enter any comments or additional information that should appear in the 26. Remarks field on CIOMS I forms.
Access Group
  • N/A
 Vault populates the assigned Case Access Group inherited from the associated global Case.
## 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 Case Field Reference. The following fields may be available:
Field Agency Description
MFDS Other Health Professional Type
  • MFDS
 Select the type of healthcare professional. This field is available on domestic Cases for Korea when the reporter's Qualification is Other Health Professional.
NMPA Report Source
  • NMPA
 For Reporter-type Case Contacts, select the report source.
NMPA Patient Nationality
  • NMPA
 For Patient-type Case Contacts, enter the 2-letter Chinese nationality code.
NMPA Patient Nationality Code
  • NMPA
 Select the code for the NMPA Patient Nationality. Vault populates the corresponding E2B code in the D.CN.1 data element of NMPA E2B(R3) files.
NMPA Patient Race
  • NMPA
 For Patient-type Case Contacts, select the patient's race.
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 Case Field Reference. ## 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 Case Field Reference. The following fields may be available:
Field Agency Description
Local MPID
  • NMPA
  • MFDS
 For External Products, enter the region-specific Medicinal Product Identification (MPID) code. For Company Products, use the Local Product Code field on Case Product Registrations.
Related Device Information
  • NMPA
 Enter information about the medical device associated with the reported adverse event. Vault populates this value in the G.k.CN.2 data element of NMPA E2B(R3) files.
Trade Name
  • NMPA
 Based on the Case Product, Vault maps the Trade Name from the related Localized Product with Chinese as the Localization. Vault populates this value in the G.k.2.2 data element of NMPA E2B(R3) files.
Generic Name
  • NMPA
 Based on the Case Product, Vault maps the Generic Name from the related Localized Product with Chinese as the Localization. If the Generic Name is blank or no applicable Localized Product exists, Vault maps the Product (Coded) value from the Case Product and appends 无中文名. Vault populates this value in the G.k.CN.1 data element of NMPA E2B(R3) files.
MAH Product
  • NMPA
 For External Products, Vault populates No. Vault populates this value in the G.k.CN.3 data element of NMPA E2B(R3) files.
CTA Approval Number(s)
  • NMPA
 From any Study Products related to the Case Product, Vault comma separates all CTA Approval Numbers starting with the earliest-created Study Product records. When the value exceeds 250 characters, Vault maps remaining CTA Approval Numbers to the Additional CTA Approval Numbers field.
Additional CTA Approval Numbers
  • NMPA
 When the CTA Approval Number(s) field reaches its character limit, Vault comma separates additional CTA Approval Numbers from Study Products related to the Case Product.
### 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 Case Field Reference. The following field may be available:
Field Agency Description
Local Product Code
  • NMPA
  • MFDS
 Enter the region-specific product code for the substance.
### Localized Case Product Device Code Section {#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 Case Field Reference. For more information about PMDA-only fields, see PMDA Case Field Reference. The following fields may be available:
Field Agency Description
Case Product
  • N/A
 Vault populates a link to the Case Product linked to the Device Code.
Case Product Device Code
  • N/A
 Based on the Device Code Type selected on the global Case and the active IMDRF dictionary version, Vault populates the Device Code.
Localized Case
  • N/A
 Vault populates a link to the Localized Case.
Localized Case Product
  • N/A
 Vault populates a link to the Localized Case Product.
Device Code Type
  • N/A
 Vault maps the selected IMDRF annex name for the category of Device Code on the global Case.
Local Code
  • N/A
 Enter the local device code.
## 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 {#ae-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 {#assessment-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
Name Vault populates the name of the Localized Case Assessment.
Case Assessment Vault populates a link to the Case Assessment.
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) Vault indicates whether the Expected field was Vault-calculated or manually overridden. You can modify this value, if needed.
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

Vault populates 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 you run the Retrieve Reportable Case Product Registrations action, 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 Vault populates the Case Product Registration for the Case Product.
Datasheet Vault populates the local or core Datasheet used to evaluate the Expectedness of the Case Adverse Event.
Datasheet Document Vault populates 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 overwriting 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_. For more information about PMDA-only fields, see PMDA Case Field Reference. The following fields may be available:
Field Agency Description
Localized Assessment Result
  • MFDS
  • NMPA

Select an assessment result.

When Vault generates a Localized Case for China, Vault populates a value based on the Assessment Result on the global Case Assessment Result as follows:

  • For Related, Vault populates Positive
  • For Probably Related and Reasonable Possibility, Vault populates Likely
  • For Possibly Related, Vault populates Possible
  • For Unlikely Related and Not Related, Vault populates Probably Unrelated
  • For Not Applicable, Vault populates Not Available
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 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 field 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 {#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 Case Field Reference. The following fields may be available:
Field Agency Description
Case Narrative
  • N/A

Vault populates 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.
Narrative Preview
  • N/A
 Vault populates a preview of the narrative that will be populated in generated regulatory reports. This field is read-only and automatically updated with a text excerpt of the local language narrative document, up to 32,000 characters. 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 and fetus outcome.
## 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 Case Field Reference. The following field may be available:
Field Agency Description
MFDS Other Study Type
  • MFDS
 Select the MFDS Study Type. This field displays when the Study Type is 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 {#docs-fields} 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 {#generate-docs} 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_: * ICSR Transmissions Overview * Submission Generation and Linking for PMDA Localized Cases * Create an ICSR Transmission