Prepare a Localized Case

Vault Safety supports Case translations to meet local submission requirements.

Sections in This Article

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, the system generates a Localized Case for the appropriate locale.

As part of the process for generating a Localized Case, the system 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.

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, administrators must enable localized submissions and translation support.
  • The following items should be set up by an administrator:
    • 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

      Note Manually setting a Transmission's Destination to an Organization with a non-Global Localization setting also results in a Localized Case being generated.

Supported Languages and Locales

Vault supports a number of languages by default. See Vault Platform help 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.

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.

Note In the standard Vault Safety template configuration, the PMDA (Japan) and MFDS (Korea) Organization records have the Localization field populated with their respective locales.

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:

Example Localized Case Process
Example Localized Case Process

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

The system 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.

Note We recommend that Localized Cases are not translated until the initial Case is in the Approved state to ensure that the data is finalized before translation.

How to Generate a Localized Case

The system 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

The system automatically generates Localized Cases for the target languages required for submissions.

Re-Evaluate Reporting Obligations for Localized Transmissions

The Re-evaluate Reporting Obligations 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.

This action is available from the download-doc menu on a Localized Case.

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

If Vault finds a matching reporting rule:

  • Vault creates a new Transmission if no localized Case exists in an In Progress state.
  • OR
  • If there are localized Cases in an In Progress state, the Transmission field values of the Case(s) 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 Case(s) and moves them to the Withdrawn state.

An In Progress transmission refers to any transmission that is in one of the following states:

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

Translating Case Data

The system 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.

Note Fields with data that is transmitted through code in E2B, including MedDRA, are not translated.

Narrative Translation

For every Localized Case record that is generated, the system generates a corresponding narrative document to be used for the narrative translation.

The system populates the Localized Case narrative document with the English narrative at the point in time when the Localized Case was generated.

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

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 Follow-Up Localized Cases

When a Follow-Up Case is created with the Localization field set to a non-global value, a Localized Follow-Up Case is generated automatically. All of the related Localized Case records and localized field data are copied to the Follow-Up Localized Case. If the Follow-Up Case is created from an Inbox Item, new data from the Inbox Item is merged into the Localized Follow-Up Case.

Because Localized Follow-Up Cases are automatically generated when the global Follow-Up Case is created, the system does not allow edits to Follow-Up Localized 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 Synching

Contact Veeva Support to request foreign Localized Case synching in your Vault.

If enabled, when a global Follow-Up Case is automatically or manually transmitted, the system 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.

Note If a Localized Follow-Up Case exists and has a Transmission record, data will not be synched.

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.

Details Section

Use the Details section to view information about the Localized Case being prepared.

  • Localized Case Details Section
    Localized Case Details Section
  • Localized Case Details (China)
    Localized Case Details (China)
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.
Local Awareness Date
  • PMDA
Enter the date when the local affiliate became aware of the report.
Global Due Date
  • N/A
The system automatically populates this field using the Due Date field on the Case.
Localized Parent Information
  • PMDA
  • 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 CIOMS I Generation Data Mapping.

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.

  • Localized Case Contact
    Localized Case Contact
  • Localized Case Contact (China)
    Localized Case Contact (China)
  • Localized Case Contact (Korea)
    Localized Case Contact (Korea)

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. There are no local fields in the address section. For information about the fields in this section, see the global Case field equivalents.

Localized Case Contact Address Section
Localized Case Contact Address Section

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.

  • Localized Case Product
    Localized Case Product
  • Localized Case Product (China)
    Localized Case Product (China)

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
  • PMDA
  • 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.

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 Dosage
Localized Case Product Dosage

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 Indication
Localized Case Product Indication

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.

Localized Case Product Substance
Localized Case Product Substance

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
  • PMDA
  • NMPA
  • MFDS
Enter the region-specific product code for the substance.

Product Registrations Section

Use the Product Registrations section to add Case Product Registrations, with PMDA (Japan) region-specific product registration details.

Case Product Registration
Case Product Registration

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

Field Agency Description
PMDA Rank
  • PMDA

Enter a number to assign the PMDA Rank. The rank of 1 identifies the primary product for PMDA E2B(R3) reports.

In PMDA E2B(R3) exports, the system transmits section G.k for all Case Product Registrations under the Japan Localized Case that contain a value in the PMDA Rank field, ordered by rank.

At least one Case Product Registration must be assigned PMDA Rank 1 to export an E2B file with PMDA mappings.

Local Product Code
  • PMDA
Enter the region-specific product code.
Clinical Compound Number
  • PMDA
Enter the Japanese Clinical Compound Number (CCN) of the investigational drug.
OTC Drug Classification
  • PMDA
Select the PMDA OTC Drug Risk category.
OTC Drug Channel
  • PMDA
Select the route of acquiring the OTC drug.
OTC Drug Channel Reason Omitted
  • PMDA
When you do not know how the patient obtained the OTC drug or must mask the channel information, select the reason this information is unavailable.
Registration Type
  • PMDA
Select the product registration type. The following options are available:
PMDA Registration Type Registration Category (INV/ PMK)
Under EPPV PMK
Within 2 Years After Approval PMK
Unapproved INV
Under Partial Change Trial INV
Not Applicable PMK
Under Re-examination PMK
Post Market Study PMK
Approved (excluding investigational drugs) INV
Unapproved (excluding investigational drugs) INV
PMDA Reporting Category
  • PMDA
The reporting category that adverse event belongs to under the PMDA guidelines. This field is available when using Domestic Case Processing and Case Follow-Up (domestic or foreign). The PMDA Reporting Category determines:
  • If the Case is domestic or foreign.
  • If the Case report type is Infection, Adverse Event, Research, or Safety Measure Report.
Select the reporting category from the dropdown menu. The following options are available:
Category Description
AA Post-Marketing Domestic Infection
AB Post-Marketing Domestic AE
AC Post-Marketing Foreign Infection
AD Post-Marketing Foreign AE
AE Post-Marketing Research Infection
AF Post-Marketing Research AE
AG Post-Marketing Safety-Measures
DA Clinical Trial Domestic Infection
DB Clinical Trial Domestic AE
DC Clinical Trial Foreign Infection
DD Clinical Trial Foreign AE
DE Clinical Trial Research Infection
DF Clinical Trial Research AE
DG Clinical Trial Safety-Measures
Completeness
  • PMDA
Select the option that best describes the completeness of the data collection at the time of the PMDA Report.
Immediate Report Type
  • PMDA
Select System (E2B) to classify this report as an Immediate Report in PMDA reporting. When System (E2B) is selected, this field corresponds to code 1 in the PMDA J2.3 E2B data element.
Report Overview
  • PMDA
Enter a summary of the research or safety measure case. This field is used only for PMDA research and safety measure reports.

Case Comments Section

Use the Case Comments section to add Case Comments, with PMDA (Japan) region-specific comments.

Localized Case Comment
Localized Case Comment
Field Agency Description
Case Product
  • N/A
The Case Product to which this comment applies.
Case Product Registration
  • N/A
The Case Product Registration to which this comment applies.
Comments Label
  • PMDA

Select a label to describe the type of comment. The option that you select in this field determines how this Case Comment is exported in PMDA E2B(R3) reports. The following table outlines the E2B data elements corresponding to each option:

Comments Label E2B Element
Company Comments (companys_comments__v) H.4
Receipt Date Comments (receipt_date_comments__v) J2.2.2
Comments on Completeness (comments_on_completeness__v) J2.7.2
Downgrade Reason (downgrade_reason__v) J2.8.2
Retrospective analysis of infections (retrospective_analysis_of_infections__v) J2.9
Future Actions (future_actions__v) J2.10
Other References (other_references__v) J2.11
Comments Text
  • PMDA
Enter the comment.

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.

Localized Case Adverse Event
Localized Case Adverse Event

Assessment Section

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

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.

Localized Case Assessment
Localized Case Assessment

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.

Localized Case Assessment Result
Localized Case Assessment Result

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.

Localized Case Cause of Death
Localized Case Cause of Death

Medical History Section

Each Case Medical History 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.

Localized Case Medical History
Localized Case Medical History

Drug History Section

Each Case Cause Drug History 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).

Localized Case Drug History
Localized Case Drug History

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 Cause Test Result 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.

Localized Case Test Result
Localized Case Test Result

Narrative Section

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 for NMPA (China).

Localized Case Narrative Section
Localized Case Narrative Section

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 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.

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).

Localized Case Study Section
Localized Case Study Section

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.

Localized Case Identifier
Localized Case Identifier

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:

Localized Case Submissions & Distributions Section
Localized Case Submissions & Distributions Section

Auto-Submissions
Prepare Vaccine Submissions
Feedback?