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 |
|
Vault populates a link to the global Case. |
| Name |
|
Vault populates a Localized Case name. |
| Localization |
|
Vault populates the language and country of the Localized Case. |
| Global Due Date |
|
Vault populates the Due Date on the global Case. |
| Due Date |
|
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 |
|
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 |
|
Select the NMPA report classification. |
| NMPA Report Source |
|
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 |
|
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 |
|
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:
|
| CIOMS Remarks |
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Enter any comments or additional information that should appear in the 26. Remarks field on CIOMS I forms. |
| Access Group |
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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 |
|
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 |
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For Reporter-type Case Contacts, select the report source. |
| NMPA Patient Nationality |
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For Patient-type Case Contacts, enter the 2-letter Chinese nationality code. |
| NMPA Patient Nationality Code |
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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 |
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For Patient-type Case Contacts, select the patient's race. |
| Use Domestic State Code |
|
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:
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 |
|
Enter the region-specific product code for the substance. |
Localized Case Product Device Code 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 |
|
Vault populates a link to the Case Product linked to the Device Code. |
| Case Product Device Code |
|
Based on the Device Code Type selected on the global Case and the active IMDRF dictionary version, Vault populates the Device Code. |
| Localized Case |
|
Vault populates a link to the Localized Case. |
| Localized Case Product |
|
Vault populates a link to the Localized Case Product. |
| Device Code Type |
|
Vault maps the selected IMDRF annex name for the category of Device Code on the global Case. |
| Local Code |
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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
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 |
|---|---|
| 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:
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 |
|
Select an assessment result. For Localized Cases for China, Vault maps a value based on the Assessment Result on the global Case Assessment Result as follows:
Vault maps this value to the following reports and data elements:
|
| Localized Assessment Source |
|
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 field may be available:
| Field | Agency | Description |
|---|---|---|
| Local MPID |
|
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 Case Field Reference.
The following fields may be available:
| Field | Agency | Description |
|---|---|---|
| Case Narrative |
|
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 |
|
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 |
|
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 |
|
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
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: