Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
Case Processing
Features in this section are additions or improvements to Vault Safety case processing.
Auto-Expectedness
To increase case processing efficiency, Vault Safety can now automatically determine whether a Case is unexpected using Product Datasheets.
For each Product, you can create Local Datasheets (USPI or SmPC for example), which are specific to a Product Registration, and a Core Datasheet (CCDS), which is the central datasheet for a Product. Local Datasheets list expected adverse events, and can optionally inherit additional events from the Core Datasheet.
If an Adverse Event is not listed on a Local Datasheet for a suspect product, the system marks the Case as unexpected. If a serious Case is determined to be unexpected, the system marks the Case as expedited.
Manage Product Datasheets provides more information.
Auto-Calculations
For efficiency and accuracy during case processing, Vault Safety now auto-calculates a number of E2B(R3) submittable fields when sufficient information is entered on a Case.
Vault Safety can auto-calculate the following fields:
- Case Product > Cumulative Dose
- Case Product Dosage > Duration
- Case Assessment > First Dose Latency
- Case Assessment > Last Dose Latency
- Case Adverse Event > Duration
When required, you can manually override an auto-calculated value.
MedDRA Auto-Code During E2B Import
Vault Safety now supports the automatic coding of medical terms from the MedDRA Dictionary during an E2B import. The system automatically assigns MedDRA codes when the E2B file contains reported event text but no MedDRA code.
Code MedDRA Terms provides more information.
WHODrug Search Criteria Auto-Fill
Finding a product with the WHODrug browser is now faster than ever with automatic searching.
When you open the WHODrug Search window, Vault Safety automatically populates and runs the search query with the reported product name and country entered on the External Product or Drug History record.
WHODrug UI Enhancements
This release includes the following enhancements for the WHODrug Dictionary:
- The WHODrug dictionary user interface has been updated to comply with WHODrug certification requirements.
- Sections that support WHODrug coding are better organized in this release, hiding the read-only WHODrug information fields until you code a product.
Case Information Ranking
Vault Safety now supports ranking Case Adverse Events, Products, Reporters, and Assessments during case processing. Ranked information is listed in ascending order on the Case page and in generated MedWatch 3500A reports.
Create Follow-Up Case From Potential Match
When you promote an Adverse Event Report that contains follow-up information for an existing Case, you can now create a Follow-Up Case from the Potential Matches page.
Designated Medical Events
Customers with a product registered in the European Union (EU) will benefit from the new Designated Medical Events (DME) feature.
The official DME watch list will be available by default in all Vault Safety vaults. When a Case Adverse Event MedDRA Preferred Term (PT) matches an entry in the watchlist, Vault Safety automatically marks the Case as a DME and expedites the reporting due date.
To avoid non-compliance during an EMA inspection, users can subscribe to alerts about non-serious DME Cases with a Flash Report. Administrators can also configure the Case Processing workflow to require the entry of seriousness criteria for DME Cases.
Common Terminology Criteria for Adverse Events Grades
A new field is available on the Case Adverse Event object to select the Common Terminology Criteria for Adverse Events (CTCAE) grade for cancer patients.
PADER Aggregate Reports
Vault Safety now supports generating and authoring Periodic Adverse Drug Experience Reports (PADER). Vault Safety can generate the following PADER tabulations using Cases entered in the system:
- Overall Summary of Adverse Drug Reactions
- 15-Day Alerts
- Non-15 Day Alerts
- Individual Line Listings
To enable this feature on existing vaults, contact Veeva Services to request configuration upgrades.
Generate PADER Aggregate Reports provides more information.
Device on FDA MedWatch 3500A
When generating a MedWatch 3500A report, Vault Safety now supports Section D: Suspect Medical Device. To support this section, you can now enter medical device product information on a Case.
Also, Vault Safety can now repeat Section C: Suspect Products on additional pages to include all suspect products. In previous releases, Section C was limited to two suspect products.
Case Export Data Mapping provides more information on the updated MedWatch 3500A capabilities.
Safety Data Exchange
Features in this section are additions or improvements to Vault Safety data exchange capabilities.
Configurable AS2 Gateway
Vault Safety now supports AS2 (system-to-system) communication to exchange E2B ICSRs with custom gateway endpoints.
Configure Custom AS2 Gateways provides more information.
EMA Gateway Submissions
Vault Safety now supports Individual Case Safety Report (ICSR) submissions to the European Medicine Agency (EMA) EudraVigilance Gateway, including support for importing and exporting ICSRs in the EMA E2B (R3) ICSR format.
Cases that include Studies or Products registered in a country in the European Union follow standard EMA-compliant reporting rules.
Configure EMA Gateway provides mofe information.
FDA Submission Rules
Cases that include Studies or Products registered in the United States follow standard FDA-complaint reporting rules.
Custom Agency Submission Rules
Administrators can assign custom Agency Organizations a Submission Rule to automatically generate regulatory Submissions.
Set Up Regulatory Agency Reporting Rules provides more information on configuring regulatory submission rules.
Partner Distribution Rules
Administrators can set up partner distributions to automatically generate Distributions to trading partners.
The following pages provide more information on configuring partner distributions:
E2B Case Migration
You can now migrate a Case directly from a source E2B file, bypassing the Adverse Event Report intake stage. This feature is useful to migrate external cases into Vault Safety.
Like standard Case migration, the system disables all case processing features on Imported E2B Cases. However, you can create and process a Follow-Up Case from the Imported Case.
Migrate External Cases provides more information.
Receive and Acknowledge E2B Transmissions
After receiving and importing an E2B(R3) file from another organization, Vault Safety now generates an ICH E2B(R3)-compliant acknowledgments.
Once an E2B import is complete, you can view the acknowledgment on the Inbound Transmission record. For E2B transmissions received from AS2 Gateway, Vault Safety automatically sends the acknowledgment to the origin Gateway.
Receive a Gateway Transmission provides more information.
SafetyDocs
Features in this section are additions or improvements to Vault SafetyDocs document management capabilities.
Merge PDF Action
Vault Safety and SafetyDocs can now merge multiple PDFs, contained in a binder, into a single PDF. Administrators can configure a new action on binders to start the merge PDF process. Once generated, users can download the PDF. Only documents with a viewable rendition will be merged to the PDF.
Merge a Binder to PDF provides more information.
Integrations
Features in this section are new integrations with Vault Safety or enhancements to existing integrations.
Vault Safety API
Vault Safety now integrates with the Vault API to introduce a publicly accessible endpoint for exchanging E2B(R3) files with trusted partners in Vault Safety.
Partners can send an E2B file using the Receive E2B endpoint, which automatically imports the ICSR into an Adverse Event Report. After a successful operation, you can retrieve an E2B(R3) compliant ACK.
The Vault Developer Portal provides more information on the Receive E2B API endpoint.
