Sections in This Article
- About Localized Cases
- Important Terms
- Prerequisites
- How Localized Cases are Generated
- Evaluate Reporting Obligations for Localized Transmissions
- Evaluate Reporting Obligations for Localized Case Assessments
- Translating Case Data
- Supported Languages and Locales
- Generate Localized Case Transmission Documents
- Manage Localized Follow-Up Cases
- Translation Workflow
- Enter Localized Case Data
- Details Section
- Contacts Section
- Products Section
- Product Registrations Section
- Local Reporting Details Section
- PMDA Reportable Products 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
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 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.
When the Auto-select Inbox Item Localization by Reporter Country feature is enabled, for primary Reporter-type Contacts, if the Reporter Country has a Localization record, the Localization field on the Inbox Item is automatically populated. When the Inbox Item is promoted to a Case, it is processed as a Domestic Case and a Localized Case is generated. For more information, see Prepare a Domestic Case.
Note Contact Veeva Support to consider the Inbox Item Report Type, along with the Reporter Country, to set the Localization field on the Inbox Item. See this note for more information.
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, your Admin must enable localized submissions and translation support.
- The following items should be set up by your Admin:
- 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.
- Configuration for PMDA Local Case Processing Automations.
- To use the Japan Drug Dictionary for coding External Products on Cases reportable to the PMDA, enable the Japan Drug Dictionary (JDD).
- To include Case Products with the Drug Role of Drug Not Administered when generating Localized Case Assessments, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, Localized Case Assessment generation considers only Case Products with the Suspect or Interacting Drug Role.
- For the system to generate Local Reporting Details and Submissions for Localized Cases reportable to Japan, enable PMDA Local Reporting Details Generation and Submission Linking.
Auto-Translation Framework
In addition to Vault Safety language support, you can configure your Vault to connect to Amazon Translate for translation of Case text fields. Depending on your business process, you can set up automatic or manual translation requests. For more information about the required setup, see Enable the Auto-Translation Framework for Localized Case Auto-Translation for Submissions.
Note When using the Auto-Translation Framework, Vault Safety simply imports the translated text as received. The system does not perform any quality checks on the content.
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:
- Automatically: Move the Case into the Approved state or run the Evaluate Reporting Obligations action on the Case.
- Manually: Add a Submission or Distribution.
- 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.
Note Contact Veeva Support to enable deleting the localized children and grandchildren records when you delete the Global Case children. This feature includes for Domestic and Foreign Localized Cases. An administrator must then configure the Safety General Settings. In 22R3 (December 2022), this enhancement will only require configuration enablement.
Evaluate Reporting Obligations for Localized Transmissions
The Evaluate Reporting Obligation 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.
Note If your Admin has configured your Vault to generate Localized Case Assessments, Expectedness, and Due Dates for each Japanese Case Product Registration and Adverse Event pair, see Evaluate Reporting Obligations for Localized Case Assessments for a description of this action.
The Evaluate Reporting Obligations action is available from the All Actions (
) menu on Localized Cases.
When you use this action, Vault searches for a matching reporting rule. Vault then regenerates and validates Submissions with the following conditions:
If Vault finds a matching reporting rule:
- If there are no Localized Cases in an In Progress state, Vault creates a new Transmission. OR
- If there are Localized Cases in an In Progress state, the Transmission field values of the Cases 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 Cases and moves them to the Withdrawn state.
An In Progress Transmission refers to any Transmission in one of the following states:
- Active
- Error
- Pending
- Ready for Submission
- Ready
- Validation Error
Evaluate Reporting Obligations for Localized Case Assessments
This section describes how the Evaluate Reporting Obligations action works when your Admin has configured the Japan Localization record to generate Localized Case Assessments, Expectedness, and Due Dates for each Japanese Case Product Registration and Adverse Event pair.
Prerequisites
Your Admin must configure the following Localization record features:
- Enable PMDA Local Case Processing Automations for retrieving reportable Case Product Registrations and configuring Assessment generation.
- Enable PMDA Due Dates Based on Localized Case Assessments for setting which date field is used to calculate Due Dates.
Before evaluating reporting obligations for Localized Case Assessments, ensure you have retrieved all the reportable Case Product Registrations. For more information, see Product Registrations Section.
Localized Case Assessment Due Dates
When you run the Evaluate Reporting Obligations action, Transmissions are not generated. Instead Due Dates and Due in Days calculations are populated on each Localized Case Assessment record. Details are populated as follows:
- Due in Days is calculated based on the applicable reporting rules.
- Due Date calculations depend on your Admin’s setting in the Localization record’s Localized Due Date Calculation field. The following options may be configured:
- If set to Localized Case - Local Awareness Date, the Due Date is based on the Local Awareness Date and the Due in Days evaluation. If the Local Awareness Date is blank, the system uses the New Info Date, if available, or the Receipt Date.
- If set to Global Case - New Info Date, the Due Date is based on the New Info Date and the Due in Days evaluation. If the New Info Date is blank, the system uses the Receipt Date.
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.
Supported Languages and Locales
Vault Safety 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.
Send Translation Requests Through the Auto-Translation Framework
If your organization has set up the Auto-Translation Framework, you can send Localized Case text fields to Amazon Translate for translation.
Note Narratives and documents are not currently supported through the Auto-Translation Framework.
The Auto-Translation Framework can be set up as follows:
- Automated Translation Requests: Translation requests are sent automatically when Localized Cases are generated.
- Manual Translation Requests: Translation requests are sent manually after Localized Case creation. Select the All Actions () menu, and then select Translate Localized Case.
For both automated and manual translation requests, after Vault Safety sends the translation request, the Localized Case enters the Translation Requested state.
When third-party translations are generated and returned to Vault Safety, they are automatically applied to the Localized Case. The system does not verify the quality of the translation, but simply imports it. The Localized Case enters the Translation Verification state.
Considerations for Translation Requests
- Localized Cases in the Translation Requested state are editable. If text fields are edited in this state, the updated values are overridden when translations are returned to Vault Safety.
- If the length of the translated text exceeds the character limit of any text field, the text is truncated to that field's maximum length. The system displays a notification message indicating which fields have been truncated.
- The translation must be returned within 60 minutes or the task will expire. The system displays a notification message for failed translation requests.
Cancel a Translation Request
When a Localized Case is in the Translation Requested state, you can cancel the request.
Select the All Actions () menu, and then select Cancel Translation Request.
Your Localized Case returns to the Active state and no translations will be applied. If needed, you can send another translation request.
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 Localized Follow-Up Cases
When a Follow-up Case is created with the Localization type set to Local, a Domestic Localized Follow-up Case is generated. All of the related Localized field data and Localized Case records, including foreign Localized Case records, are copied from the previous version to the Domestic Localized Follow-up Case. If the Follow-up Case is created from an Inbox Item, new data from the Inbox Item is merged into the Domestic Localized Follow-up Case. For more information, see the Localized Data section under Default Merge Behavior.
Because Localized Follow-up Cases are automatically generated when the global Follow-up Case is created, the system does not allow edits to Localized Follow-up 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 Syncing
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 synced.
If your Vault is configured to generate Localized Case Assessments for Case Product Registrations, run the Retrieve Reportable Case Product Registrations action to update Case Product Registrations and Localized Case Assessments. For new Case Products, Case Product Registration records are populated. Existing Case Product Registrations are not changed or deleted.
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 (China)
| Field | Agency | Description | ||||||
|---|---|---|---|---|---|---|---|---|
| Case |
|
Reference link to the global Case. The system automatically populates this field. | ||||||
| Name |
|
The name of the Localized Case record. The system automatically generates a record name and populates this field. | ||||||
| Localization |
|
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 |
|
For Foreign Localized Cases, enter the date when the local affiliate became aware of the report. For Domestic Localized Cases, this value is populated with the New Info Date on the Global Case. When the New Info Date is updated on the Global Case, the Local Awareness Date on the Domestic Localized Case is also updated. | ||||||
| Local Initial Receipt Date |
|
Enter the date when the Localized Case was received.
Use the calendar to select the date or enter the date manually. Specify the year, month, and day at a minimum. When populated on Localized Cases, this value is exported to the C.1.4 Date Report Was First Received from Source data element on PMDA E2B(R3) reports. If blank, the value in the Initial Receipt Date field on the Global Case is exported. This field does not appear on page layouts by default and must be added by your Admin. |
||||||
| Local New Info Date |
|
Enter the latest date when additional information was received about the Localized Case.
Use the calendar to select the date or enter the date manually. Specify the year, month, and day at a minimum. When populated on Localized Cases, this value is exported to the C.1.5 Date of Most Recent Information for This Report data element on PMDA E2B(R3) reports. If blank, the value in the New Info Date field on the Global Case is exported. This field does not appear on page layouts by default and must be added by your Admin. |
||||||
| Global Due Date |
|
The system automatically populates this field using the Due Date field on the Case. | ||||||
| Due Date |
|
The system 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 |
|
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:
|
||||||
| CIOMS Remarks |
|
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. | ||||||
| Special Adverse Event |
|
Specifies if the Adverse Event has special characteristics that affect PMDA submission. Currently, two Special Adverse Event types are supported:
When Non-reportable Event is selected, the Adverse Event is excluded from any E2B reports associated with the Localized Case.
|
||||||
| Access Group |
|
The Case Access Group on the associated global Case. This field does not appear on page layouts by default. Depending on your organization’s security configuration, it may be added by your Admin. |
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 (China) -
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 |
|
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.
For Domestic Cases, when Country State / Province records exist, the information is mapped to the Localized Case. If Localized Country State / Province records exist, the information appears in the local language. For information about the other fields in this section, see the global Case field equivalents.
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 (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 |
|
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 |
| JDrug |
|
Product code from the Japan Drug Dictionary. This field appears for External Products on Localized Cases for Japan only. After entering the reported product name, select Search JDrug to browse and select the appropriate JDrug code using the JDrug Browser. |
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.
| Field | Agency | Description |
|---|---|---|
| Local Product Code |
|
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 the global Case includes a Case Product Device Code record, a Localized Case Product Device Code section is created. When the values on the global Case are updated, these changes are synced to the Localized Case.
The following table outlines the local fields available on a Localized Case Product Device. For information about other fields, see the global Case field equivalents.
| Field | Agency | Description |
|---|---|---|
| Case |
|
Reference link to the Case. The system automatically populates this field. |
| Case Product |
|
Reference link to the Case Product linked to the Device Code. The system automatically populates this field. |
| Case Product Device Code |
|
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 |
|
Reference link to the Localized Case. The system automatically populates this field. |
| Localized Case Product |
|
Reference link to the Localized Case Product. The system automatically populates this field. |
| Device Code Type |
|
Displays the selected IMDRF annex name for the category of device code. This value is copied from the global Case. |
| Local Code |
|
Enter the local device code. This field is blank by default. |
Product Registrations Section
On Localized Cases for Japan, reportable Case Product Registrations can be added all at once through the Retrieve Reportable Case Product Registrations action, if configured. To use this action, go to the All Actions () menu, and then select Retrieve Reportable Case Product Registrations.
About Retrieve Reportable Case Product Registrations
When you retrieve reportable Case Product Registrations, the system evaluates all general- and cross-reporting obligations to populate Case Product Registration records in the following instances:
- The Japanese Registration Category is Investigational
If there are multiple matches, the system adds them all to the Localized Case. - The Japanese Registration Category is Marketing and the following details from the Localized Case Product match a Case Product Registration:
- Dose Form, Strength Number, and Strength Unit
- If the above don't all match, the system matches on Dose Form alone.
- The Japan Product Registration is set up as the default registration.
Note If there are multiple matches, the system selects the Japanese Product Registration with a matching Dose Form and the earliest created date.
- Dose Form, Strength Number, and Strength Unit
- A Product reportable to the PMDA includes the same Substance as a Suspect, Interacting, or Drug Not Administered Case Product on the Localized Case.
During Case Product Registration record creation, the following details are populated on the Case from the PMDA Product Registration:
- Clinical Compound Number
- Dose Form
- Local Product Code
- OTC Drug Classification
- Registration Country
- Registration Holder
- Registration Number
- Registration Type
- Product (Reported) Override
Note The Registration Holder value is snapshot from the Organization name. We recommend limiting this value to a maximum of 60 characters to respect the G.k.3.3 Name of Holder / Applicant data element specification on PMDA E2B(R3) reports. If this value is longer than 60 characters, Vault Safety truncates it on the Case Product Registration record.
For new Case Product and Case Product Registration pairs, the system also generates Localized Case Assessment records and evaluates adverse event Expectedness using the Datasheet for the selected Product Registration. For more information, see Assessment Section.
Existing Case Product Registration records are considered not reportable and removed from the Localized Case in the following instances:
- The Drug Role of the associated Case Product is no longer Suspect, Interacting, or Drug Not Administered.
- The associated Case Product or Study Product was deleted from the Localized Case.
Case Product Registration and Assessment records are not generated for Device or OTC-Device Case Products or Combination Product Constituents.
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 | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Registration Type |
|
Select the product registration type. The following options are available:
|
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| Dose Form |
|
Select the required Dose Form. | ||||||||||||||||||||||
| 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. | ||||||||||||||||||||||
| PMDA Rank |
|
Enter a number to assign the PMDA Rank. The rank of 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 |
||||||||||||||||||||||
| Product (Reported) Override |
|
This value is populated from the Case Product Registration record on Study Cases with the following setup:
This value is exported to the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element of PMDA E2B(R3) reports. This field supports the scenario when a foreign Case Product has multiple investigational registrations with studies conducted in Japan with the same Substance. |
Local Reporting Details Section
Use the Local Reporting Details section to add PMDA (Japan) region-specific reporting details.
If your Admin has enabled the PMDA Local Reporting Details Generation and Submission Linking feature, this section may be populated for Localized Cases with the Localization field set to Japanese (Japan). To populate the section, select the Generate Local Reporting Details action in the All Actions menu.
When configured, for Japanese Case Product Registrations with values in the Due Date and Due in Days fields, the system generates a Local Reporting Details record for each of the primary Postmarketing and Investigational Registration Types, if they exist on the Case.
The primary Case Product Registration is determined using the following priority order:
- The earliest Due Date for each Registration Type, for example, Postmarketing or Investigational.
- If there are multiple registrations for a Registration Type with the same Due Date, the highest Rank is evaluated.
- If there are multiple registrations for a Registration Type with the same Rank, the earliest Created Date is evaluated.
After generating the Local Reporting Details records, the system generates Submission records.
Note Case Product Registrations without Due Date or Due in Days values are not considered reportable by the system.
| Field | Agency | Description | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Case Product |
|
Select or search for the primary Case Product. | ||||||||||||||||||||||||||||||
| Primary Case Product Registration |
|
Select or search for the primary Case Product Registration. | ||||||||||||||||||||||||||||||
| 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:
|
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| Completeness |
|
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 1 in the PMDA J2.3 E2B data element.
|
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| Destination Case ID |
|
The value entered in the Destination Case ID field on the associated Transmission (Submission or Distribution) record. | ||||||||||||||||||||||||||||||
| Report UID |
|
The system automatically populates this field.
This identifier is generated using the following logic:
The Note The Report UID includes a [suffix] even when a Case only has a single submission. |
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| TIKEN |
|
Select the checkbox to prepend “TIKEN” to the G.k.11 Additional Information on Drug (free text) data element of PMDA E2B(R3) reports for the primary Case Product Registration.
If Local Reporting Details are generated by the system or through the Generate Local Reporting Details action, this checkbox is automatically selected for the Marketing record if all of the Investigational Case Product Registrations for the same Product have the PMDA Registration Type field set to Under Partial Change Trial (TIKEN). This checkbox is available for the PMDA-specific scenario where a foreign Case includes both postmarketing and investigational registrations for the same substance where the Registration Type is “Under Partial Change Trial” and the partial change is one of the following:
In this scenario, when the PMDA requires only a postmarketing Transmission, the system populates “TIKEN” to indicate that the investigational report was not generated. |
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| System Generated LRD Category |
|
The system populates this field with “Investigational” or “Marketing” if the system generates the Local Reporting Details (LRD). |
PMDA Reportable Products Section
Use the PMDA Reportable Products Section to associate the Local Reporting Details of the Localized Case with the Reportable Products of the Case Product or Case Product Registration.
Ranks are assigned by Registration Category and Drug Role as follows:
- For Marketing registrations, the system assigns Rank 1 to the primary Case Product Registration from the Local Reporting Details section. The system then ranks Other Postmarketing registrations in the following order based on Drug Role:
- Suspect
- Interacting
- Other
- For Investigational registrations, the system assigns Rank 1 to the Case Product Registration with a Drug Role of Suspect. The system then ranks in order based on Drug Role, including:
- Suspect
- Interacting
- Other
Note If Local Reporting Details are system-generated, the system assigns a Rank based on the Rank in the Case Product Registration section.
| Field | Agency | Description |
|---|---|---|
| Case Product |
|
The Case Product to which this comment applies. |
| Case Product Registration |
|
The Case Product Registration to which this comment applies. |
| Rank |
|
Rank indicates the order in which the products appear in the PMDA E2B(R3) file (G.k section). |
When PMDA Reportable Products records are deleted, any associated Transmission record is moved to a Deleted state type.
Case Comments Section
Use the Case Comments section to add Case Comments, with PMDA (Japan) region-specific comments.
| Field | Agency | Description | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comments Label |
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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:
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| Comments Text |
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Enter the comment. When Comment Label is set to Report Overview, the maximum number of characters is 500. | ||||||||||||||||||
| Local Reporting Details |
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Select or search for the Local Reporting Details from the Localized Case. |
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.
Assessment Section
For each Case Assessment on the global Case, a Localized Case Assessment is generated using the Local Datasheet for the country in the Localization field, if one exists.
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 Assessments for Case Product Registrations
Depending on your Admin’s configuration for the Localization on the Case, Vault Safety supports the automatic generation of Localized Case Assessment records for each Case Product Registration. To use this option for a particular Localization, your Admin must turn on the Localized Assessments for Case Product Registrations option for the related Localization record.
When turned on, for Suspect, Interacting, or Drug Not Administered Case Products, for each Case Product Registration the system generates Localized Case Assessment records and calculates Expectedness. For example, if the Localization record for Japanese (Japan) is set to generate Localized Assessments for Case Product Registrations, Localized Case Assessments are automatically generated by the system for each Case Product Registration.
With this feature, Localized Case Assessments are also generated when Adverse Events are added to Cases. When existing Adverse Events are recoded to a different MedDRA LLT, Localized Case Assessments are updated and Expectedness is reevaluated.
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Localized Case Assessment -
Localized Case Assessment for Case Product Registration
Some of the Case Assessment fields in the table below appear only when your Vault is configured to generate Localized Case Assessments for Case Product Registrations for the Localization on the Localized Case.
| Field | Description |
|---|---|
| Localized Case | Reference link to the Case. The system automatically populates this field. |
| Name | The name of the Localized Case Assessment record. |
| Case Assessment | Reference link to the Case Assessment. The system automatically populates this field. |
| Due Date | The Due Date used for reporting the Adverse Event and Case Product Registration pair. This field is populated only for Japanese Localized Cases if your Admin has configured your Vault to generate Localized Case Assessments and Due Dates for each Case Product Registration. How the system calculates the Due Date also depends on your Admin’s configuration. For more information, see Evaluate Reporting Obligations for Localized Case Assessments. If the Localized Case Assessment does not pass any reporting rules, this field is left blank. For Localizations without the PMDA Due Dates Based on Localized Case Assessments feature enabled, the Due Date is calculated at the Transmission level instead. |
| Due in Days | The number of days in which the report is due. See the Due Date field description above for details on the required configuration for the Due in Days field. The Due in Days value is calculated based on the applicable reporting rules for the Adverse Event and Case Product Registration pair. For Localizations without this feature enabled, Due in Days is calculated at the Transmission level instead. |
| Expected | Whether the associated Localized Case Adverse Event is listed on the Local Datasheet associated with the suspect Case Product or associated Study. If your Admin has configured Datasheets, the system automatically populates this field based on the expected reactions listed on the local datasheet. You can select a different option to override the system-calculated value or to enter the value manually. If there are multiple local Datasheets, the system calculates Expectedness as follows:
If there is no local Datasheet, the system applies the Case Assessment from the associated global Case. |
| Expected (status) | How the Expected field was populated, whether system-calculated or with a manual override. The system automatically populates this field, but it can be edited. |
| Case Product | The Suspect, Interacting, or Drug Not Administered Case Product. For Cases reportable to the PMDA, the system downloads all associated Products with registrations for Japan. In addition, when the Retrieve Reportable Case Product Registrations action is run, the system 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 based on which the Expectedness of the Adverse Event was evaluated. |
| 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 the system-calculated Expectedness. |
Note When the Localized Case Assessment Expectedness or Expected (status) value is overridden, the update is not synced to the global Case.
When the global Case Assessment Expectedness or Expected (status) value is overridden, the update is synced to the Localized Case Assessment if the Localized Expected (status) field is Auto Calculated. The update is not synced if the field is Overridden.
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.
| Field | Agency | Description |
|---|---|---|
| Local MPID |
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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.
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).
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 |
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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 |
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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 |
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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 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.
| Field | Agency | Description |
|---|---|---|
| MFDS Other Study Type |
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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:
