Sections in This Article
- About Localized Cases
- Important Terms
- Supported Languages and Locales
- How Localized Cases are Generated
- Re-Evaluate Reporting Obligations for Localized Transmissions
- Translating Case Data
- Generate Localized Case Transmission Documents
- Manage Follow-Up Localized Cases
- Translation Workflow
- Enter Localized Case Data
- Details Section
- Contacts Section
- Products Section
- Product Registrations Section
- Case Comments Section
- Adverse Events Section
- Assessment Section
- Assessment Result Section
- Causes of Death Section
- Medical History Section
- Drug History Section
- Test Results Section
- Narrative Section
- Study Section
- Reference Numbers Section
- Submissions & Distributions Section
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.
- Global refers to the main operating language of an international company. English is the only language considered global.
- 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.
- 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:
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.
- Generate a Transmission using one of the following methods:
- 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.
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 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:
- Ready for Submission
- 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.
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.
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.
Use the Details section to view information about the Localized Case being prepared.
||Reference link to the global Case. The system automatically populates this field.|
||The name of the Localized Case record. The system automatically generates a record name and populates this field.|
||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||
||Enter the date when the local affiliate became aware of the report.|
|Global Due Date||
||The system automatically populates this field using the Due Date field on the Case.|
|Localized Parent Information||
||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||
Select the NMPA report classification type from the drop-down menu. The following options are available by default:
||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.|
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.
|MFDS Other Health Professional Type||
||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||
||For Reporter-type Case Contacts, select the report source from the drop-down menu.|
|NMPA Patient Nationality||
||For Patient-type Case Contacts, enter the 2-letter Chinese nationality code.|
|NMPA Patient Race||
||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.
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.
The following table outlines the local fields available on a Localized Case Product. For information about other fields, see the global Case field equivalents.
||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||
||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.
|Local Product Code||
||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.
The following table outlines the local fields available on a Case Product Registration. For information about other fields, see the global Case field equivalents.
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
|Local Product Code||
||Enter the region-specific product code.|
|Clinical Compound Number||
||Enter the Japanese Clinical Compound Number (CCN) of the investigational drug.|
|OTC Drug Classification||
||Select the PMDA OTC Drug Risk category.|
|OTC Drug Channel||
||Select the route of acquiring the OTC drug.|
|OTC Drug Channel Reason Omitted||
||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.|
Select the product registration type. The following options are available:
|PMDA Reporting Category||
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:
||Select the option that best describes the completeness of the data collection at the time of the PMDA Report.|
|Immediate Report Type||
Select System (E2B) to classify this report as an Immediate Report in PMDA reporting. When System (E2B) is selected, this field corresponds to code
||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.
||The Case Product to which this comment applies.|
|Case Product Registration||
||The Case Product Registration to which this comment applies.|
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:
||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.
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.
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 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 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).
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.
||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.
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).
The following table outlines the local fields available in the Narrative section. For information about other fields, see the global Case field equivalents.
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.
||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||
||Enter any additional pregnancy-related information, such as history of previous pregnancy, fetus outcome, and so on.|
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.
|MFDS Other Study Type||
||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: