Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
New Features
Adverse Event Report Validity Check
The first step to add a new Vault Safety Case is to enter the source Adverse Event Report. After you create and enter an Adverse Event Report, the system verifies that the report includes the criteria to qualify as a valid individual case safety report (ICSR). An administrator can configure custom criteria for the system to verify.
When an adverse event report contains all of the criteria to qualify as a valid case, you can promote the Adverse Event Report to a Case. Adverse Event Report Overview provides more information.
Adverse Event Report Import
Vault Safety supports importing source files to create an Adverse Event Report. This feature includes populating data from E2B (R2) and (R3) files.
When you import an E2B file, the system extracts the data from the file and maps the information to the matching Vault Safety fields in a new Adverse Event Report. E2B Case Import Data Mapping describes how Vault Safety maps E2B data to a Case.
When you create an Adverse Event Report from a source document, such as a .pdf literature source, the system populates the Organization and Source fields on the Adverse Event Report. Create an Adverse Event Report provides more information.
Duplicate Case Detection
When you start Case promotion, the system automatically compares the source Adverse Event Report against all other Cases and Adverse Event Reports in the system to prevent duplicate adverse event processing.
If the Adverse Event Report is a duplicate of a Case, Vault Safety marks the Adverse Event Report as duplicate and does not create a Case. See Promote an Adverse Event Report to a Case for more information.
Case Processing Workflows
Vault Safety includes a pre-configured Case Processing workflow that automatically assign tasks to guide the Case from Data Entry to Approval and Submission.
See Case Processing Overview for more information about the case processing workflow.
Personal Identifiable Information Field Encryption for Cases
The system encrypts standard Personal Identifiable Information (PII) fields captured in a Vault Safety Case. Once field-level encryption is enabled, only authorized users within vault can access the encrypted information.
Manage Field Encryption provides information on which fields are encrypted and how to encrypt additional fields.
Standardized Medical Dictionaries
Built on modern industry standards, Vault Safety supports industry-standards for medical coding and structured data entry.
MedDRA Coding
Vault Safety supports the Medical Dictionary for Regulatory Activities (MedDRA) to code terms for symptoms, disease, indicators, and adverse events. You can code an event using either the LLT or PT code. See Code MedDRA Terms for more information.
An administrator must upload a MedDRA dictionary to enable coding.
WHODrug Coding
Quickly search, filter, and find standardized medicinal product codes in our IDMP-compliant WHODrug dictionary. The WHODrug dictionary browser makes it easy to find and code products and their corresponding MPIDs during case processing. See Code WHODrug Terms for more information.
Veeva manages the WHODrug dictionary and updates it biannually. However, an administrator must activate the WHODrug dictionary.
Units of Measurement
Vault Safety supports E2B (R3) units of measurement for dose, strength, and time intervals, including support for both the unified code of units of measure (UCUM) and the constrained UCUM.
Controlled Vocabulary
Vault Safety supports the ICH Controlled Vocabularies for Drug Safety and E2B data transmission.
Route of Administration
Vault Safety supports the E2B (R3) data entry standard for route of administration terms. You can enter the route of administration as text or as a code from the E2B (R2) dictionary.
Enhanced Case Narratives
Vault Safety leverages Vault Document Management capabilities to support enhanced narrative document composition, including annotating, versioning, and editing.
Access narratives from the Case and edit narratives on your local machine or directly in your browser with Microsoft Office Online. See Compose a Case Narrative for more information.
Case Assessment Generation
Vault Safety automatically generates a Case Assessment for each suspect product and serious adverse event using data entered on the Case.
This feature ensures the proper mapping of Case Assessments and increases productivity and speed for the reviewer completing the assessments. See Enter a Case Assessment for more information.
Case Locking
Case locking improves access control and data integrity. When a Case is approved, the Case and all of its related data transitions to a locked state, preventing unapproved updates.
When a Case is submitted and closed, it continues to be locked to prevent deviations from submitted reports that would trigger an audit violation.
Locked Case Revision Workflow
Once a Case is locked, authorized users can initiate a Case Revision workflow for a Case to incorporate non-significant follow-up information received from reporting sources.
After the Case Revision workflow, the Case moves back to the Approved state and is locked to prevent changes. See Revise an Approved Case for more information.
Follow-up Cases
Vault Safety supports creating Follow-Up Cases when you must process new case information. When you add a Follow-Up Case, the system creates a new version of the case and carries over all the information and documents from the previous version of the case.
See Add a Follow-Up Case for more information.
User Access Control
Vault Safety protects data by restricting user access to information and records based on their organization and application role. Users must be assigned an application role in their organization to see case-related data and participate in Case Processing workflows.
With this feature, CROs can assign each customer access to Vault Safety, and each customer can only view data belonging to their organization. For more information, see Managing Permissions with User Roles.
Blind Protection
For double-blinded studies, Vault Safety blinds all Cases linked to that study, including imported Cases. If a blinded Case is assessed as serious and unexpected after QC review, the system starts the unblinding workflow and assigns unblinding tasks to authorized users in the Medical Reviewer role.
When you unblind a Case, Vault Safety activates blind protection. Blind protection continues to mask sensitive information that could compromise the integrity of the study from unauthorized users.
Only users with appropriate permissions can see blind-protected information. By default, only users assigned the Medical Reviewer or Head of Safety role can see blind-protected information.
When you add the study to your environment, you can configure Case blinding settings. See Manage Case Blinding for more information on blind protection.
Aggregate Reporting
Vault Safety supports ICH-compliant aggregate reports for product families, including one-click table generation and collaborative document editing for PBRERs and DSURs. This feature includes a workflow for generation, authorship, and a red-line comparison view between table versions.
The system processes relevant Case data within the specified time period to generate aggregate report tables and populate their data. See Aggregate Reports Overview for more information.
Health Authority Reporting and Submissions
Vault Safety includes workflows to support both manual and electronic submissions of Individual Case Safety Report (ICSR) to the FDA.
See Submissions and Distributions Overview for more information.
Individual Case Safety Report Export
Vault Safety supports generating ICSRs in the following standardized formats:
- E2B (R2)
- E2B (R3)
- CIOMS I
- FDA 3500A
The system maps Case data to populate the appropriate fields on the report. During report generation and submission, Vault Safety ensures that files are fully compliant, maintain case versions, and support multiple distribution and submission destinations.
Generated files appear in the Vault Library and are versioned during regeneration. Generate a Regulatory Report provides more information.
FDA AS2 Electronic Submissions Gateway Integration
Schedule Submissions and send individual case safety reports (ICSR) directly to the FDA through the AS2 Electronic Submissions Gateway (ESG). Submit initial, follow-up, amendment, and nullification ICSRs.
Support includes Submissions for biologics and drugs as well as handling of ICSR attachments and acknowledgments. See Submit a Case to the FDA Gateway for more information.
Manual FDA Submissions Tracking
When you cannot submit a case electronically, you can generate submittable case reports and track the manual submission through the Manual Submission workflow. Submit a Case to the FDA Manually provides more information.
FDA Submission Rules
Set up automatic due date and submission rules for all Cases reportable to the FDA. Vault Safety supports rule-based determination of Case due dates and submissions. This feature includes post-market, study, and follow-up reports. The system assigns reporting due dates based on the Case seriousness criteria.
See Complete Case Triage for default submission rule settings. Administrators can configure custom due dates when configuring studies.
Interactive Dashboards and Reports
Drill down through real-time, interactive dashboards to narrow in on the exact source of processing and reporting delays. Take action directly from the reports to address hold-ups and stay on track for submission deadlines. Reports and Dashboards Overview provides more information.
Case Migration Mode
Case Migration Mode is a setting that allows you to migrate external cases to Vault Safety with Vault Loader or Vault API. Contact Veeva Support for assistance with enabling Migration Mode and importing external cases. Migrate External Cases provides more information.
Feature Enablement
The following table describes how to enable each new feature in this release.
| Feature | Enablement |
|---|---|
| Adverse Event Report Validity Check | Auto-On |
| Adverse Event Report Import | Auto-On |
| Duplicate Case Detection | Auto-On |
| Case Processing Workflow | Auto-On |
| Personal Identifiable Information Field Encryption for Cases | Auto-On |
| MedDRA Coding | Configuration |
| WHODrug Coding | Configuration |
| Units of Measurement | Auto-On |
| Controlled Vocabulary | Auto-On |
| E2B Route of Administration | Auto-On |
| Enhanced Case Narratives | Auto-On |
| Case Assessment Generation | Auto-On |
| Case Locking | Auto-On |
| Locked Case Revision Workflow | Auto-On |
| Follow-Up Cases | Auto-On |
| User Access Control | Configuration |
| Blind Protection | Configuration |
| Aggregate Reporting | Configuration |
| Individual Case Safety Report Export | Auto-On |
| FDA AS2 Electronic Submissions Gateway Integration | Configuration |
| Manual FDA Submissions Tracking | Auto-On |
| FDA Submission Rules | Configuration |
| Interactive Dashboards and Reports | Configuration |
| Migrate External Cases | Support |
