23R1 New Features

Learn about new features and feature enablement for the Vault Safety Suite in 23R1.

Last Updated

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 23R1. For details about new features in the Vault Platform in 23R1, see the Vault Release Notes.

Safety

Vault Safety 23R1 introduces the following new features.

Intake

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

Configurable Inbox Item Sections and Custom Case Fields for Manual Intake

Config

Admins can now configure the list and order of Inbox Item fields for the Details, Patient, Contact, Medical Events, and Products sections. Admins can also hide Medical History and Drug History in the Medical Event and Products sections. Finally, Admins can select custom Case fields for the Inbox Item Details and Patient sections. Users can then manually enter values for the selected fields during intake and the system can copy these values to Case upon promotion.

Learn More

Local Case Import to Inbox Item

Admin Checkbox

Vault Safety can now import local language text to the Inbox Item localized fields to facilitate translation to English in the global fields. When enabled, the system imports the text values to the localized or global fields based on the set Localization.

Learn More

Local Intake Auto-Translation Framework

Config

With this release, Vault Safety can now use the Amazon Translate Connection to translate local text fields to English to allow for global Case processing. In other words, you can now use a third-party service to translate Inbox Item text fields from the reporter’s local language to English during Case intake.

Admins can enable translations by configuring a user action. Admins can also configure the localizations, fields, and volume limits for translations.

Learn More

Pregnancy Case Intake

Config

Intake users can now mark an Inbox Item as Pregnancy Case to track pregnancy exposure or to report an Adverse Event suffered by the mother. Upon Case promotion, Child Information placeholders and Case Test Results will be automatically created to facilitate data entry.

Learn More

PII Masking on Potential Matches Page

Admin Checkbox

With this release, Admins can enable personally identifiable information (PII) masking on the Potential Matches page where Atomic Security is not enforced.

Learn More

Indexing of New Migrated Cases for Duplicate Search

Admin Checkbox

With this release, Admins can initiate indexing of newly migrated Cases to include them in duplicate detection.

Learn More

Simplified Case Intake for Studies

Auto-On

Inbox Items now support manual intake for unarmed studies. Based on the selected Study, Study Product selection will use either Study Arms or Study Products. In addition, Case Products can now be marked as Blinded, Unblinded, or Open-Label when a blinded Study is selected.

Learn More

New Duplicate Search Algorithm Enablement Update

Auto-On

With this release, the New Duplicate Search Algorithm feature is Auto-On. This feature was originally introduced in 22R3 with Support-enablement. Although the feature is Auto-On in Vaults with Inbox Items enabled, Admins still control the deep duplicate search options through Case Promotion settings. This feature is available for Inbox Items only, and is not supported for AERs.

Read more about this feature in the 22R3 New Features list.

Record Selection Usability Enhancements for Inbox Items

Auto-On

With this release, searching and selecting records from the Study, Country, and Product Registration dropdown fields during Inbox Item data entry is made easier by displaying recently used values at the top of the list. These fields also now include a binoculars icon for browsing and filtering the available options. In addition, searching and selecting records in picklist fields (for example, Dose Form and Patient RoA) is made easier by displaying exact matches at the top as you type.

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.

Case Access Group Security

Config

With Case Access Groups, Vault Safety significantly simplifies security around access to Cases based on Case data, including Sponsor, Report Type, Country, and Market Segment. In addition, this feature provides more granular control over unblinded information and personally identifiable information (PII) at the object and field levels. For example, Admins can manage access to non-sensitive data for specified open and non-Study Products, Drug Roles, and Study Product Roles.

Learn More

Case Access Groups: Workflow Participants by Role

Auto-On

When using Case Access Groups, Vault Safety can now assign workflow tasks by role on the Case, Localized Case, and Transmission.

Note: This feature is auto-on only after you have enabled Case Access Groups.

Learn More

Generate Assessments Record Action

Support

Vault Safety now gives Case Processors the ability to generate Assessments, Assessment Results, and Expectedness records for all serious and non-serious Adverse Events on a Case. Completed in a single action, this feature improves Case processing efficiency by removing the need to generate each required record manually.

Learn More

Record Selection Usability Enhancements for Cases

Auto-On

With this release, searching and selecting records from picklist fields during Case data entry is made easier by displaying exact matches at the top as you type.

Domestic Case Edit Enhancements

Auto-On

With this release, global Case Processors can view and edit global information in dual-text app controls, even while the localized Case is still generating.

Case Locking User Interface Enhancements

Auto-On

This feature introduces enhancements to manual and strict Case locking. If another user applies manual or strict Case locking, the relevant user actions will not be displayed or available for you to run in the All Actions menu. This improvement affects only the user interface and contains no functionality changes.

Case Compare: Descriptive Error Messages

Auto-On

This feature introduces more descriptive error messages on the Case Compare page. These enhanced messages help users understand issues that may occur when merging an Inbox Item to an in-flight Case or creating a Follow-Up Case.

Learn More

Coding

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

Automatic MedDRA Hierarchy Updates

Auto-On

Vault Safety now enables downloading the latest central MedDRA dictionary version as soon as it becomes available. With the download complete, when you update the active version in your Vault, all of the global and localized terms, as well as any hierarchy changes, are automatically applied to MedDRA terms referenced on Cases. This means that you can immediately start the required verifications. In addition, it reduces the manual effort of bulk recoding, enabling MedDRA Admins and Medical Coders to focus on currency status changes, policy, and best practices.

Learn More

Smart MedDRA Coding

Config

Vault Safety Smart MedDRA Coding offers advanced coding of MedDRA terms that aren’t an exact match to the active dictionary or your synonym list. Using AI and automation, this feature overcomes common problems such as alternate and incorrect spelling, abbreviations, and multiple reported terms. For Case Processors, this means less time spent on manual MedDRA coding.

For Admins, configuring Smart MedDRA Coding reduces the manual effort of maintaining the MedDRA Synonym list. As terms are coded, they are automatically added to the synonym candidate list, making coding more streamlined and consistent over time.

Learn More

IMDRF Bulk Snapshotting

Config

With this release, when an IMDRF Dictionary version is updated, the system now downloads the full dictionary. Admins can choose when to transition to a new version and receive notifications when updating and downloading are complete.

Learn More

EDQM Dose Forms and Routes of Administration Enablement Update

Auto-On

With this release, the EDQM Dose Forms and Routes of Administration feature is Auto-On. This feature was originally introduced in 22R2 with Admin Checkbox-enablement.

Read more about this feature in the 22R2 New Features list.

Reporting Rules

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

Enhanced Eligible Products Selection for Cross Reporting

Support

With this release, Vault Safety uses improved logic to determine the product driving ICSR reporting requirements in cross reporting scenarios. Contact Veeva Support to enable this feature in your Vault.

Additionally, Admins can modify the behavior of the Product and Study rule parameters when evaluating cross reporting scenarios. Admins can configure this behavior only after Support has enabled the improved logic feature.

Learn More

Parameter Driven Assessment Selection for Rules Engine

Support

Previously, the most conservative product and assessment rule parameter evaluation strictly relied on Case Seriousness, Expectedness, and Relatedness being defined in the Distribution Rules. This can lead to under-reporting for common rule sets. Vault Safety can now employ a more tolerant rule parameter evaluation based on the configuration of relevant reporting rules.

Learn More

Support for New Company Products Type in Safety Data Exchange

Config

Vault Safety Data Exchange now supports the new Company Product product types, such as Cosmetics and Nutritional. In addition, the Vault Safety rule engine now supports rules based on product type. For example, you can configure FDA Submission rules specific to OTC Drugs so that this product type won’t be subject to the same Submission rules as prescription drugs.

Learn More

Safety Report Generation

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

Generate E2B Formats for Migrated Cases

Auto-On

With this release, preview generation of E2B(R3) files and Transmission generation of all E2B formats are now available for migrated Cases.

Learn More

All Product Types Available for FDA 3500A and CIOMS I Generation

Support

With this release, Vault Safety supports generating MedWatch 3500A and CIOMS I forms for device-only Cases. To accommodate reporting on additional classes of Products (for example, Over the Counter and Cosmetics), exporting Company Product types is also supported.

Learn More

MedWatch 3500A and CIOMS I Preview Generation for Open Label Study Arms

Auto-On

With this release, Vault Safety supports generating MedWatch 3500A and CIOMS I preview forms for Cases that use an Open Label Arm from a Blinded Study.

Learn More

Aggregate Reports

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

CIOMS II Line Listing Expectedness

Auto-On

The CIOMS II standalone report in Vault Safety now supports different expectedness logic for Clinical Trial and Postmarketing Cases in the same report. Clinical Trial expectedness will be based on the Investigational Brochure (IB)/Study datasheets, while Postmarketing Cases will use the Product datasheet.

Learn More

PADER Date Filtering Criteria Enablement Update

Auto-On

With this release, the PADER Date Filtering Criteria feature is Auto-On. This feature was originally introduced in 22R3 with Support-enablement.

Read more about this feature in the 22R3 New Features list.

New Info Date for PADER Line Listings

Support

For PADER Line Listings, previously, the Initial Report Date and a Transmission Date represented the date the FDA first received the Case. With this release, a New Info Date column will be added to the Interval Line Listings and to the Non-Primary Suspect Drug Report, which will be populated from the Case. When you filter the PADER data on the New Info/Receipt Date, you can see what date was used as the inclusion criteria for the report.

The Transmission Date has been added to the log of the 15-Day and Non-15 Day report and the log of the Summary of Adverse Events Report to assist in troubleshooting.

Essentially, all four (4) PADER reports now have both the Receipt/New Info Date and the Transmission Date.

Learn More

Submissions and Distributions

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

Partner AS2 Gateway Connections

Support

This release introduces a number of enhancements for Vault Safety gateway connections administration to facilitate managing allowlists and certificates, as well as testing gateway connections.

Learn More

PMDA Multi-Submission with Localized Case

Auto-On

With this release, Vault Safety supports multiple PMDA Submissions from a single Case.

Learn More

Integrations

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

External Connection SDK Support for Custom E2B Export

Config

With this release, Vault Safety introduces faster exports of custom E2B formats. This makes generating E2B files for large Cases more efficient.

Learn More

SafetyDocs

Vault SafetyDocs 23R1 introduces the following new features.

PSMF Binder Approvals

Auto-On

Vault SafetyDocs can now manifest approval pages on generated PSMF PDFs.

Learn More

PSMF Binder Table of Contents

Config

Vault SafetyDocs can now automatically generate a table of contents for PSMF Binders when merging to PDF.

Learn More

PSMF Logbook Format Enhancements

Auto-On

The PSMF Logbook in SafetyDocs has been enhanced to have a clearer format. The new Excel template is automatically available in all Vaults. To use this feature, you must first remove any previously generated logbooks in your existing PSMF binders.

Learn More

Literature Process Management

Config

Vault SafetyDocs now supports the management of literature articles and article reviews. This feature includes the data structure and document types necessary for Literature Management. Future enhancements will leverage this data structure.

Learn More

PVA Document and Obligation Management

Config

Vault SafetyDocs now supports the management of of pharmacovigilance agreements (PVAs) and Safety Data Exchange agreements (SDEAs). This feature includes the data structure and document types necessary for PVA Management. Future enhancements will leverage this data structure.

Learn More