Sections in This Article
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 Domestic Cases
Vault Safety supports Case processing for Domestic Cases. Domestic Case processing provides region-specific fields and dual-language fields for entering data in a non-English language on a Case.
A Domestic Case is for cases that must be reported to the same jurisdiction where the adverse event occurred, in the local, non-English language. If a product involved in a Domestic Case has a registration to an English-reporting country (such as the FDA and EMA), you can enter English translations on the Domestic Case.
Using a Domestic Case, you can perform data entry in the local language the report was received in, while translating to English. This is a different workflow from localizing a Global (English) Case to a different language, which is through Localized Cases.
Domestic Cases support region-specific fields for the following agencies:
- PMDA (Japan)
- NMPA (China)
- MFDS (Korea)
For domestic cases originating in a country, such as Spain or Italy, where the state code is required in submissions to a specific agency, such as the EMA, Vault Safety provides a configurable Country State/Province library. During intake and case processing, users select the Country State/Province from a picklist. The system maps the domestic state codes upon E2B(R3) import and export. For more information, see Enable Domestic Case Processing for Agency Jurisdications.
Prerequisites
For Vaults created earlier than 21R3, Admins must complete the following configuration:
- Enable Domestic Case Processing to process Domestic cases
For Vaults created earlier than 21R2, Admins must complete the following configuration:
- Enable Localized Submissions and Translations Support
- Enable Local Fields for PMDA (Japan) for Japanese case processing
- Enable Local Fields for NMPA (China) for Chinese case processing
- Enable Local Fields for MFDS (Korea) for Korean case processing
Consider the following additional optional setup:
- 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 Assessments, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, Assessment generation considers only Case Products with the Suspect or Interacting Drug Role.
- For the system to generate Local Reporting Details and Submissions for Domestic Cases reportable to Japan, enable PMDA Local Reporting Details Generation and Submission Linking.
Create a Domestic Case
Vault Safety automatically generates a Domestic Case once you promote an Inbox Item with the Localization field set to a non-English value. See Perform Local Language Intake for more information.
When the Auto-select Inbox Item Localization by Reporter Country feature is enabled, for primary Reporter-type Contacts, if the Country has a Localization record, the Localization field on the Inbox Item is automatically set based on the Reporter’s Locale. See the Country field on the Inbox Item Field Reference for more information.
Your Admin can also configure the system to set Inbox Item Localization using both the Primary Reporter Country and Report Type. See the logic for how the system auto-sets Localization.
After promoting an Inbox Item (created through Intake in a non-English language) to a Domestic Case, you can view and process Domestic Cases entirely in the reported language from the Data Entry through to the Medical Review stage of the Case processing lifecycle. Domestic Case Processing is completed on the Cases tab.
Re-generate a Domestic Case
If a Domestic Case did not successfully generate after promoting an Inbox Item, you can use the Re-generate Domestic Case action to trigger Domestic Case generation. This action is available from the Actions menu on a Localized Case.
Note This action will generate all child records or any child records that have been deleted.
Set Vault Default Language
You can view fields in Vault in your preferred language by selecting a language from your User Profile. When you change this setting, all field labels and picklist values in Vault will display in the selected language. The Default Localization field determines the language in Object Reference fields, such as Report Type.
Note If the Default Localization field is blank, the system automatically refers to the Language field to determine the language for the picklist field values.
Enter Translations
When an Inbox Item is created through Intake in a non-English language with the Localization field set to a non-global value, you can enter Inbox Item data in the reported language for all sections of the Inbox Item.
See Create an Inbox Item Manually for more information on creating inbox items.
Note When processing Domestic Cases, Vault Safety includes dual-language entry so you can perform data entry in both the Reporter’s local language and English at the same time. By default, text fields, picklist and object fields, and adverse events are available for dual-language entry. However, your administrator can configure Localization Scope to limit dual-language entry to Narratives, Company Comments, or both.
E2B file export respects the Localization Scope setting. For example, if the Localization Scope is set to Narrative, only the Localized Narrative is exported on the E2B file. All other fields are English only.
Manual Text Translation
You can manually translate text fields during intake. For each text field that supports dual language intake, there are two fields:
- In the first field, enter the information in the language the adverse event was reported in.
- In the second field, marked with , enter the English translation.
Code Multilingual MedDRA Terms
You can enter MedDRA terms in the reported language of the Case. The system will automatically determine and select a language from the dropdown menu next to the Auto-code button.
When you select Auto-code with a valid MedDRA term in any of the supported languages, Vault will automatically translate the MedDRA code into English below the MedDRA field.
See Code Multilingual MedDRA Terms for more information on coding MedDRA terms in non-English languages.
Text Field Mapping on Case Promotion
When a Domestic Case is created upon Case promotion, the Inbox Item local text fields (that have data entered in their native language) are mapped to the corresponding local text fields on the Domestic Case in the same language.
The following table describes how Vault Safety maps Inbox Item local text fields to the local text fields on the Domestic Case:
Inbox Item | Domestic Case | ||
---|---|---|---|
Section | Field | Object | Field |
Details > Awareness Details | Reporter’s Comments (Native) | Localized Case (Narrative) | Reporter's Comments |
Details > Awareness Details< | Reporter’s Comments (English) | Case Version (Narrative) | Reporter's Comments< |
Case Contacts > Contact | Additional Information (Native) | Localized Case Contact | Additional Information |
Case Contacts > Contact | Additional Information (English) | Case Contact | Additional Information |
Case Contacts > Contact | Organization (Native) | Localized Case Contact | Organization |
Case Contacts > Contact | Organization (English) | Case Contact | Organization |
Case Contacts > Contact | Department (Native) | Localized Case Contact | Department |
Case Contacts > Contact | Department (English) | Case Contact | Department |
Case Contacts > Primary Reporter | State/Province | Case Contact > Reporter | State/Province |
Product | Product (Native) | Localized Case Product | Product (Reported) |
Product | Product (English) | Case Product | Product (Reported) |
Product | Indication (Native) | Localized Case Product Indication | Name (Reported) |
Product | Indication (English) | Case Product Indication | Name (Reported) |
Product > Case Product > Dosage | Dose Text (Native) | Localized Case Product Dosage | Dose Text |
Product > Case Product > Dosage | Dose Text (English) | Case Product Dosage | Dose Text |
Medical Events > Medical history & Concurrent Conditions | Event (Native) | Localized Case Medical History | Name (Reported) |
Medical Events > Medical history & Concurrent Conditions | Event (English) | Case Medical History | Name (Reported) |
English Field Translation Mapping
On Case promotion, only the field translations are mapped to the Global Case. The field values in the local language are not copied over to the Global Case.
The following table describes how Vault Safety maps text fields with local and English values on Case promotion:
Inbox Item | Case | ||
---|---|---|---|
Section | Field | Object | Field |
Details | Reporter Comments | Case (Narrative) | Reporters Comments |
Case Contact | Additional Information | Case Contact | Additional Information |
Case Contact | Organization | Case Contact | Organization |
Case Contact | Department | Case Contact | Department |
Product | Product (Reported) | Case Product | Product (Reported) |
Product > Dosage | Dose Form (Custom)* | Case Product Dosage | Dose Form |
Product > Dosage | Patient RoA (Custom)* | Case Product Dosage | Patient RoA |
Product > Dosage | Dose Text | Case Product Dosage | Dose Text |
*Text translations are only available when entering custom Dose Forms or Patient RoAs. Translations for standard system-provided Dose Forms and Patient RoA values are automatically mapped upon Case promotion. |
About the Local Narrative Preview
When you promote an Inbox Item to a Domestic Case, the system generates a localized and English Narrative document. The system compares the Case details against available custom narrative templates, and applies the template with the most matching details.
Comparison includes the following Case details:
- Case Type (E2B or manual)
- Organization
- Sponsor
- Report Type
- Study Type
- Study
- Blinded or Unblinded
If no custom template details match, a system-provided narrative template is applied to the Case. For non-E2B imports, the Narrative documents will be blank by default.
You can edit the system-generated Narrative document or upload another document to replace the Narrative text. The local Narrative document and the English document are also linked in this section.
Note You cannot edit either of the Narrative previews at the Case-level.
About PMDA Product Registrations
For Domestic Cases for Japan, when a Japan Product Registration is selected for the Case Product, the system populates Case Product Registration records and the associated Assessment records during Case Promotion and when the Re-generate Domestic Case action is used.
Case Product Registration and Assessments are also generated in the following scenarios:
- When a Case Product with a PMDA Product Registration is added with a Drug Role of Suspect, Interacting, or Drug Not Administered
- When the Product Registration of an existing Case Product with a Drug Role of Suspect, Interacting, or Drug Not Administered is changed from a blank or non-PMDA Product Registration to a PMDA Product Registration
- When the PMDA Product Registration of an existing Case Product with a Drug Role of Suspect, Interacting, or Drug Not Administered is changed to a different PMDA Product Registration
The system deletes Case Product Registration and associated Assessment records when an existing Case Product with a Drug Role of Suspect, Interacting, or Drug Not Administered has the Product Registration changed from a PMDA Product Registration to either a non-PMDA Product Registration or is made blank.
Case Product Registration Records
If your Admin has enabled the PMDA Local Case Processing Automations feature, select the Evaluate Regulatory Conformance action from the All Actions menu for the system to populate Case Product Registrations for Japan.
During Case Product Registration record creation, the following details are snapshotted from the PMDA Product Registration:
- Clinical Compound Number
- Dose Form
- Local Product Code
- OTC Drug Classification
- Registration Country
- Registration Holder
- Registration Number
- Registration Type
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.
Case Product Registration and Assessment records are not generated for Device or OTC-Device Case Products or Combination Product Constituents.
PMDA Case Product Registration Fields
Field | Description |
---|---|
Name | Enter the Name of the Case Product Registration. |
Registration Country | When the Product Registration is selected, the system populates the Registration Country from the record in the Product Library. |
Product Registration | Select a PMDA Product Registration from the dropdown menu. Product registrations are created when you configure the Product. |
Rank | To order Case Products by rank, enter the rank number. Products ranked as 1 correspond to the primary product role. If you change a product to rank 1, the system updates the rank of the previous primary product to 2. Ranked records appear in descending order on the Case and in generated ICSR documents.This field does not appear on page layouts by default and must be added by an administrator to appear. |
Due Date | The system populates this field with the earliest regulatory due date for this Case Product Registration. This is calculated based on the earliest Localized Case Assessment Due Date if one exists. If no Localized Case Assessment associated with this Case Product Registration has a Due Date populated, this field is left bank. |
Due in Days | The system calculates this value for the Case Product Registration based on the most conservative Localized Case Assessment. |
PMDA Local Reporting Details Section
If your Admin has enabled the PMDA Local Reporting Details Generation and Submission Linking feature, this section may be populated for Domestic 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 | ||||||||||||||||||||||||||||||
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Primary Case Product |
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Select or search for the primary Case Product. | ||||||||||||||||||||||||||||||
Primary Case Product Registration |
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Select or search for the primary Case Product Registration. | ||||||||||||||||||||||||||||||
PMDA Reporting Category |
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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 |
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Select the option that best describes the completeness of the data collection at the time of the PMDA Report. | ||||||||||||||||||||||||||||||
Immediate Report Type |
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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 |
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The value entered in the Destination Case ID field on the associated Transmission (Submission or Distribution) record. | ||||||||||||||||||||||||||||||
Report UID |
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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). |
When PMDA Reportable Products records are deleted, any associated Transmission record is moved to a Deleted state type.
PMDA Reportable Products Section
In this section, 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.
Case Comments Section
Use the Case Comments section to add Case Comments, with PMDA (Japan) region-specific comments.
Field | Agency | Description | ||||||||||||||||||
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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 |
|
Select or search for the Local Reporting Details from the Localized Case. |
Datasheet Documents Known Issue and Workaround
When creating a Follow-up to a Domestic Case, Localized Case Assessment records are copied to the Follow-up Case, but the Datasheet Document link is not populated.
Workaround
To view the Datasheet Document, select the link to the Datasheet on the Follow-up Case. Where one exists, the Datasheet Document is available from the Datasheet record.
Browse and Add Japan Drug Codes
For Domestic Cases for Japan, you can add Japan Drug Dictionary (JDD) codes to External Products. This feature supports compliant Submissions to the PMDA. For more information, see Code Japan Drug Dictionary Products.