Note Beginning with 23R2.2 and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
The following new features for Vault Safety are introduced in release 23R1.2. For details about new features in the Vault Platform in 23R1.2, see the Vault Release Notes.
Vault Safety 23R1.2 introduces the following new features.
Features in this section are additions or improvements to Case intake.
Study Site Reporter on Inbox ItemSupport
Admins can now configure Study Contacts to use as Site Reporters during the initial intake of Inbox Item Study Cases. This feature was previously only available for AERs, but now Intake users can select the appropriate Site Reporter during Inbox Item intake. Upon Case promotion, the system populates all required details of the Site Reporter on the Case, increasing data entry efficiency and accuracy. This new feature is particularly important because it streamlines the Case intake process, reduces the risk of errors, and ensures compliance with regulatory requirements. The ability to configure Study Contacts for use as Site Reporters facilitates identifying and selecting the appropriate person for the role, saving Intake users valuable time and effort.
The following video provides a demo of using Site Reporters for Inbox Items:
Features in this section are additions or improvements to Case processing, including data entry, triage, medical review, auto-calculations, and general case management.
New Substance Name Field in Product LibraryConfig
To match E2B guidance, the Vault Safety Product Library includes a new Substance Name field that supports up to 250 characters. The increase from 128 characters means more accurate substance descriptions can be used, improving compliance on E2B Transmissions. When generating Substance Names on Cases, the system downloads values from the new field, if populated, or will continue to download from the existing field. This logic supports setting up longer Substance Names only when required.
- Enablement: Enable the New Substance Name Field in the Product Library
- Admin Help: Manage Products: Add Substances
Features in this section are additions or improvements to the Vault Safety reporting rules engine.
Custom Rulesets and Rules ConfigurationConfig
Vault Admins can now configure Custom Reporting Rulesets and Rules for global Agencies and Trading Partners without having to request approval by raising a Support Ticket. This provides the flexibility to configure Safety rulesets based on your business needs.
- Admin Help: Create Custom Safety Rule Sets
Prioritize Seriousness for DowngradesAuto-On
To ensure more accurate transmission creation for Downgrade and Upgrade reports, when Vault Safety calculates the Most Conservative Product for Submission Rules, Serious Adverse Events are always prioritized over Non-Serious Adverse Events as shown in the following table:
||Unexpected||Related||1 (Most Conservative)|
|NSE||Non-Serious||Expected||Unrelated||9 (Least Conservative)|
|1. If a case contains both a Life Threatening SUSAR and a Fatal SUSAR, the tiebreaker for Most Conservative Assessment will be the Fatal SUSAR.|
Safety Report Generation
Features in this section are additions or improvements to ICSR report generation.
OTC Carton Attachment Export for FDA E2B(R2)Auto-On
To adhere to FDA guidelines for reporting cases with Over-the-Counter (OTC) products, Vault Safety now supports attaching images of OTC cartons when sending FDA E2B(R2) Transmissions through an AS2 Gateway.
- User Help: Enter Case Data: Documents Section
Features in this section are additions or improvements to Vault Safety Aggregate Reports.
Aggregate Report Interval Case ListingConfig
Vault Safety now provides in-system access to a comprehensive listing of all Cases included in the interval report for a specific Aggregate Report (DSUR, PBRER, PADER, PSUR, CIOMS II) with this aggregate report Case linking feature.
You can incorporate the new Aggregate Report Case object into your analytics reports to verify that all relevant Cases are captured.
This feature provides greater insight and control over the regulatory reporting process.
Submissions and Distributions
Features in this section are additions or improvements to Vault Safety Submissions and Distributions.
PMDA Local Receipt Date OverridesConfig
For PMDA E2B(R3) Submissions, local Case Processors can now enter values for Receipt Date (C.1.4) and New Info Date (C.1.5), overriding the dates from related Global Cases. This feature introduces two (2) new fields on Localized Cases, Local Initial Receipt Date and Local New Info Date, offering greater alignment with PMDA and NMPA guidelines.
Domestic Local Awareness Date SynchronizationAuto-On
To ensure dates remain consistent, reduce manual data entry, and support on-time Case Submissions, the Local Awareness Date on Domestic Localized Cases is now populated with the New Info Date from Global Cases.
- User Help: Prepare a Localized Case: Details Section
Manual Transmission Creation AutomationAuto-On
To increase efficiency for business users when manually creating Submission or Distribution records, Vault Safety now populates the following fields on a transmission based on the selected Transmission Profile:
- Outbound Format
- Additional Output Format
- Sender User
- Message Subject (Including Tokens)
- Message Body (Including Tokens)
- Cover Letter Template
Feature Enablement Changes
Enablement changes apply to the following features in this release:
|Feature||Previous Enablement||New Enablement|
|Enhanced Eligible Products Selection for Cross Reporting||Support (23R1)||Auto-On (23R1.2)|
|All Product Types Available for FDA 3500A and CIOMS I Generation||Support (23R1)||Configuration (23R1.2)|
See the following articles to learn more about these features:
- Enhanced Eligible Products Selection for Cross Reporting: 23R1 New Features list
- All Product Types Available for FDA 3500A and CIOMS I Generation: 23R1 New Features list
Vault SafetyDocs 23R1.2 introduces the following new features.
PSMF Version BindingConfig
Vault SafetyDocs now automatically selects the correct PSMF document versions when creating a draft of the PSMF binder and when reviewing and approving PSMF binders. Previously, users had to manually edit the binder and select which version of the documents to include.
This feature improves the efficiency of the review process, reduces the risk of errors, and ensures compliance with regulatory requirements.