Prepare a Domestic Case

Learn how to process Domestic Cases with region-specific data in the reported language.

Note Beginning with 24R1 in April 2024 and for all subsequent releases, Vault Safety General Release Help content is moving to a new site. Test the new site using Limited Release content.

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:

For Vaults created earlier than 21R2, Admins must complete the following configuration:

Consider the following additional optional setup:

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.

The Default Localization and Language Fields on the User Profile
The Default Localization and Language Fields on the User Profile

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.

The Localization Field
The Localization Field
The Reporter Section with Japanese Text Entered
The Reporter Section with Japanese Text Entered

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:

  1. In the first field, enter the information in the language the adverse event was reported in.
  2. In the second field, marked with English, 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.

The Localized MedDRA Term Coded
The Localized MedDRA Term Coded

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 English 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 English 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.

The Narrative Section of a Japanese Localized Case
The Narrative Section of a Japanese Localized Case

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

Case Product Registration Section
Case Product Registration Section
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:

  1. The earliest Due Date for each Registration Type, for example, Postmarketing or Investigational.
  2. If there are multiple registrations for a Registration Type with the same Due Date, the highest Rank is evaluated.
  3. 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.

Local Reporting Details
Local Reporting Details
Field Agency Description
Primary Case Product
  • PMDA
Select or search for the primary Case Product.
Primary Case Product Registration
  • PMDA
Select or search for the primary Case Product Registration.
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.
For Cases with the Localization set to Japan, the system assigns the Reporting Category when the Local Reporting Details record is created or updated through the Generate Local Reporting Details action, based on the following attributes:
  • Whether the primary Case Product Registration of the Local Reporting Details is Postmarket or Investigational
  • Whether the primary Reporter Country is Japan
  • Whether the Case has a Special Report Classification, either Research Report or Safety Measure
  • Whether the Localized Case has a Special Adverse Event designated as Infection
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.
Destination Case ID
  • PMDA
The value entered in the Destination Case ID field on the associated Transmission (Submission or Distribution) record.
Report UID
  • PMDA
The system automatically populates this field.

This identifier is generated using the following logic:

case_number__v.name__v + suffix

The suffix is a two-letter sequence that increments by one letter from the last suffix of the existing Local Reporting Details record. The sequence starts with ‘AA’ and increments by one letter for each subsequent record (for example, AA, AB, AC, AD, and so on). Any unused suffixes in the sequence are used first.

Note The Report UID includes a [suffix] even when a Case only has a single submission.

TIKEN
  • PMDA
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:

  • Route of Administration
  • Strength
  • Efficacy
  • A new, changed, or deleted Indication

In this scenario, when the PMDA requires only a postmarketing Transmission, the system populates “TIKEN” to indicate that the investigational report was not generated.

System Generated LRD Category
  • PMDA
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
    For Investigational registrations with the same Drug Role, the system assigns Rank based on the Rank in the Case Product Registration section.

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.

Localized Case Comment
Localized Case Comment
Field Agency Description
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 (sender_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
Report Overview (report_overview__v) J2.16
Comments Text
  • PMDA
Enter the comment.
When Comment Label is set to Report Overview, the maximum number of characters is 500.
Local Reporting Details
  • PMDA
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.


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