23R1.2 New Features

Learn about new features in 23R1.2.

Last Updated Aug 25, 2023

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.

Safety

Vault Safety 23R1.2 introduces the following new features.

Intake

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

Study Site Reporter on Inbox Item

Support

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:

Learn More

Enablement: Enable Study Site Reporter: (23R1) Add the Site Reporter Field to the Inbox Item Page Layout
Admin Help: Manage Studies: Set Up Study Site Reporters
User Help: Inbox Item Field Reference: Site Reporter

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.

New Substance Name Field in Product Library

Config

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.

Learn More

Enablement: Enable the New Substance Name Field in the Product Library
Admin Help: Manage Products: Add Substances

Reporting Rules

Features in this section are additions or improvements to the Vault Safety reporting rules engine.

Custom Rulesets and Rules Configuration

Config

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.

Learn More

Admin Help: Create Custom Safety Rule Sets

Prioritize Seriousness for Downgrades

Auto-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:

Summary	Seriousness	Expectedness	Relatedness	Ranking
Fatal/LT SUSAR	Fatal, or Life Threatening¹	Unexpected	Related	1 (Most Conservative)
SUSAR	Serious	Unexpected	Related	2
SU	Serious	Unexpected	Unrelated	3
SESAR	Serious	Expected	Related	4
SE	Serious	Expected	Unrelated	5
NSUR	Non-Serious	Unexpected	Related	6
NSU	Non-Serious	Unexpected	Unrelated	7
NSER	Non-Serious	Expected	Related	8
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.

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User Help:

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.

Learn More

User Help: Enter Case Data: Documents Section

Aggregate Reports

Features in this section are additions or improvements to Vault Safety Aggregate Reports.

Aggregate Report Interval Case Listing

Config

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.

agg-report-interval-listing-case-interval-report-section — Listing of Cases on Interval Report for Aggregate Reports

You can incorporate the new Aggregate Report Case object into your analytics reports to verify that all relevant Cases are captured.

agg-report-interval-listing-case-object-analytics — New Aggregate Report Case Object in Analytics

This feature provides greater insight and control over the regulatory reporting process.

Learn More

Admin Help: Enable Interval Case Listing for Aggregate Reports
User Help:
- DSUR
- PBRER
- PADER
- PSUR
- CIOMS II

Submissions and Distributions

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

PMDA Local Receipt Date Overrides

Config

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.

Learn More

Enablement: Enable Local Receipt Date Overrides
User Help: Prepare a Localized Case: Details Section

Domestic Local Awareness Date Synchronization

Auto-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.

Learn More

User Help: Prepare a Localized Case: Details Section

Manual Transmission Creation Automation

Auto-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:

Origin
Destination
Outbound Format
Additional Output Format
Sender User
Message Subject (Including Tokens)
Message Body (Including Tokens)
Cover Letter Template

Learn More

User Help:
- Create a Submission: Submission Fields
- Create a Distribution: Distribution Fields

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

SafetyDocs

Vault SafetyDocs 23R1.2 introduces the following new features.

PSMF Version Binding

Config

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.

Learn More

Enablement: Enable PSMF Version Binding
User Help: Manage PSMF Binders and Logbooks