22R2 New Features

Learn about new features and feature enablement in 22R2.

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Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.

The following features are introduced in 22R2. For details about new features in the Vault Platform in 22R2, see the Vault Release Notes.

Intake

Features in this section are additions or improvements to case intake.

E2B Rendition

Auto-On

Vault Safety will now automatically generate a visual E2B rendition during an import to Inbox Item, showing each E2B element ID, name, the value imported, as well as any E2B import issues.

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Field Limit Updates for E2B (Enablement Change and Data Migration)

Auto-On

Vault Safety now supports the maximum E2B-compliant field limits for Dose Text, Transmission Reason, and Test Result Value. This feature was originally introduced in 22R1 through Support-enablement. In 22R2, this feature is automatically supported in all environments.

The Case Product Dosage > Dose Text field and Case Test Result > Test Result Value fields will be automatically replaced on page layouts and available for data entry. However, the Localized Case Product Dosage > Dose Text and Transmission > Transmission Reason fields must be replaced on page layouts, if required for data entry. Existing field data and security configuration will be copied from the pre-existing Dose Text, Transmission Reason, and Test Result Value fields to the new fields.

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Respect User Default Localization on Inbox Item

Auto-On

Inbox Items now display Object Reference field values in the language set on the Default Localization field of your user profile. For example, when User Default Localization is set to Japanese (Japan), the Report Type field will display values in Japanese.

Note This feature is automatically available if either the Local Intake or Domestic Processing feature is enabled.

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Case Processing

Features in this section are additions or improvements to case processing, including data entry, triage, medical review, auto-calculations, and general case management.

Domestic Case Processing for Agency Jurisdictions

Config

This release brings multiple enhancements to domestic case processing. Administrators can now manage a Country State/Province library with configurable support for state/province codes. You can select the Country State/Province from a picklist during intake and case processing. The system will map the domestic state codes upon E2B(R3) import and export. This enhancement is 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.

Administrators can also now manage the type and scope of localization for domestic case processing. The localization scope can be for all fields or specific to Narratives and/or Company Comments. If configured, the localized values for Company Comments and Narratives will also be exported in E2B formats.

Additionally, this feature introduces two new Vault Settings for system administrators. One setting is to configure Inbox Item localization to default based on Reporter Country and Language. Another setting is introduced to prevent auto-submissions when a Case contains unapproved Localized Cases.

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Combination Product FDA E2B(R2) Export and Case Processing Enhancements

Auto-On

In this release, Vault Safety provides multiple enhancements for FDA E2B(R2) generation related to drug/biologic-led combination products having device constituents. Combination Products are now exported as a single drug block, with the device constituent referenced within the block. In addition, device product codes and brand names are exported to FDA E2B(R2). Vault Safety will also support adding combination products during data entry after Case promotion. Finally, Vault Safety will no longer automatically generate Case Assessments or Expectedness records for device constituents, which can be error-prone and lead to unnecessary work during case processing.

Note While this feature is Auto-On, an administrator must add the Trade Name and Product Code fields to Case Product page layouts to expose those fields for manual data entry.

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Narrative Templates for Report Types and Studies

Config

This release enhances the administration of narrative templates. You can now configure and maintain narrative templates by Organization, Report Type, Study Type, Study, and Localization. During Case promotion, the system matches the Case to an appropriate template based on the specified fields. Also, you can now re-render a Case narrative document to refresh merge field tokens without versioning the document.

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Pagination in Dose Section Control

Auto-On

With this release, the Dosage section control supports paging and the manual creation of more than 10 dosages per product on a Case.

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Auto-Calculations: Warnings for Overridden Values

Config

Vault Safety now provides a user option to enable or disable auto-calculation for certain fields. While editing a field on the Case, the system informs you when this field change will impact other field values. Upon saving the record, the system will also notify you when a previously manually entered field value will be overridden with a system-calculated value, if auto-calculation is enabled.

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Partial Date Support for Product-Level Device Fields

Config

Vault Safety now supports partial date entry for Combination Products with device constituents for Implanted Date, Explanted Date, and Returned Date. The system will support E2B import and export of these partial dates for FDA E2B(R2). All existing field data and security configuration will be automatically copied from the pre-existing fields to the new partial date fields.

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Partial Date Support for Dose-Level Expiration

Auto-On

Vault Safety now supports partial date entry at the Case Product Dosage-level for Expiration Date. This feature is auto-on for customers using the Case Product Dosage section control. All existing field data and security configuration will be automatically copied from the pre-existing expiration_date_v field to the new expiration_date_idate_v field.

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Copy Patient Information from Existing Case

Admin Checkbox

Upon promoting an Inbox Item, Vault Safety now supports the ability to copy patient information from previous Cases. You can select the following case information to be copied from an existing case to a new case: Patient Details (required), Medical History, Drug History, Case Contacts, Test Results, and Suspect/Interacting Products. Additionally, Adverse Events can be copied to Medical History and Concomitant Products can be copied to Drug History.

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Foreign Localized Case Synching (Enablement Change)

Auto-On

On a follow-up Localized case, Vault Safety performs a one-time data sync from the global case to the localized case when the associated transmission record is created. The system also prevents user edits to the follow-up Localized Case until it is ready for transmission evaluation. This feature was originally introduced in 22R1 through Support-enablement. In 22R2, this feature is automatically supported in all environments.

Coding

Features in this section are additions or improvements to Vault Safety medical coding capabilities.

Support for Unconstrained UCUM for Test Result Units

Auto-On

Vault Safety will now support test result units from the unconstrained (infinite) UCUM dictionary to align with E2B(R3) specifications. This support will extend to migrations, E2B imports, E2B/CIOMS/3500A generation, and Case processing.

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Improvements to WHODrug Browser and Substance Coding

Auto-On

When selecting an External Product from the WHODrug browser, the Substance information is now snapshotted to the Case, which aligns with E2B(R2) Submission requirements. Some improvements have also been made to the WHODrug Browser, such as the order of columns and filters prioritizing the most referenced product details. This makes it easier to select external products.

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EDQM Dose Forms and Routes of Administration

Admin Checkbox

To support mandatory EDQM standard terminology for pharmaceutical dose forms and routes of administration when reporting to EudraVigilance, Vault Safety now supports mapping those fields to the latest EDQM terms when importing and exporting E2B files. When EDQM terms are added or changed, Vault Safety will update its EDQM Dictionary through maintenance releases.

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Safety Report Generation

Features in this section are additions or improvements to ICSR report generation.

Receiver Information Export for E2B(R2) and PMDA E2B(R3)

Config

Vault Safety now supports the generation of the Receiver Block in the E2B(R2) formats. Additionally, this release updates the export logic for PMDA E2B(R3) to include recipient information in the J2.18 block.

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Generate and Manage Standalone CIOMS II Line Listing

Config

Vault Safety now provides the ability to generate the CIOMS II Line Listing as a standalone report, independent of the PSUR aggregated report. All features available in the current PSUR line listing are also available in the standalone CIOMS II. Additionally, both masked and unmasked versions can be generated.

The default version of the report contains all the data required to meet regulations. Optionally, users can choose to include additional fields to the report (for example, Study ID, Patient ID, EUDRA CT number, Seriousness, Assessment Results, and Action Taken).

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Submissions and Distributions

Features in this section are additions or improvements to Vault Safety Submissions and Distributions.

One Last Time Reporting Rule Evaluation for Downgrade Scenarios

Auto-On

Vault Safety can now accommodate downgrade scenarios when evaluating if a case qualifies for a one-last-time reporting rule to a specific destination. This enhancement was previously patched in the 22R1.0.8 maintenance release requiring Support enablement, but with 22R2 this enhancement becomes Auto-On.

Optimized BFC E2B(R2) Export

Auto-On

Vault Safety now supports the generation of E2B(R2) formats with optimized backward-forwards compatibility logic. This export logic enhances support for global health authorities including Health Canada.

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Case Data Validations and Always Evaluate Criteria

Config

Vault Safety can now validate case data without an E2B-based submission format. It can also evaluate validation criteria regardless of reportability (for example, submissions to health authorities).

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Multi-Format Submissions and Distributions

Config

Vault Safety now supports the automated generation of multiple document formats within a single transmission record. For example, a CIOMS I and MedWatch 3500A form can be generated within the same Distribution record to transmit to a partner or ethics committee. Additionally, Transmission Profile overrides are now considered when determining which file format validations should be run.

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Reporting Family Jurisdictions and Distribution List Management

Config

This release includes three enhancements to Reporting Families for Distributions.

Vault Safety now supports specifying Reporting Family Jurisdictions on Partner Distribution Lists. When evaluating the Case, the system uses the list of countries defined to create Distributions for each Partner. In addition, you can now specify the Transmission Profile Override parameter on a reporting rule to override the standard Transmission Profile selection. Finally, MAH Distribution Lists are now automatically removed when the MAH or Reporting Organization value is deleted from all related Product or Study Registrations.

The Transmission Profile override and deletion of MAH Distribution List enhancements are automatically available. However, defining jurisdictions for partner distributions requires configuration.

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Integrations

Features in this section are new integrations with Vault Safety or enhancements to existing integrations.

Import to Inbox Item for Receive E2B API and Safety Link

Config

Admin users will now be able to switch the import of E2B through the Receive E2B API and Safety Link to the Inbox Item using the Transmission Profile “Import to Inbox Item”. The field is now available on all Transmission Profile types, including the Partner Exchange Transmission Profile type.

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System

Features in this section are changes or improvements to the Vault Safety system.

Enable Configurable Deletion Rules for Standard Case Grandchildren, Localization, Transmission, Inbox Item Objects

Config

The Vault platform capability for configurable object Deletion Rules is now available for Case Assessment children (Assessment Results, Assessment expectedness), Case Product children (Case Product Dosage, Indication, Substance), Localized Case children (for example, Localized Case Assessment), Transmission children (Transmission Message), and Inbox item children (Inbox Item Control). Administrators can configure the Deletion Rules for these objects to “Cascade delete children records” for easier object record maintenance.

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See Vault Help for more information about this feature.

Safety Suite Manifest Update and Tabs

Config

Vault SafetyDocs has an increased number of standard objects available. Tabs have been added to the application manifest. Appropriate tabs will appear as Safety applications are enabled and disabled.

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