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 20R3. For details about new features in the Vault Platform in 20R3, see the Vault Release Notes.
Safety
Vault Safety 20R3 introduces the following new features.
Case Processing
Features in this section are additions or improvements to Vault Safety case processing.
Automatic Email of Case Questionnaire & Scheduled Reminders
Vault Safety can now automatically send questionnaires to a reporter by email depending on the product, country, language, and watchlist. Vault Safety will also send reminders to the reporter a specified number of times at specified intervals. In addition, the system can track whether these emails are delivered and opened.
Admins must perform configuration to enable Automatic Email of Case Questionnaire & Scheduled Reminders.
Learn More:
- Set Up Scheduled Follow-Up Questionnaire Emails
- Send a Follow-Up Email Questionnaire to a Case Reporter
System Managed Lock Object Protection (Approved, Closed, Superseded, Locked)
The Vault Safety system now has mandatory edit protections on all standard Case-related objects in the Approved, Closed, and Superseded states. As before, with system-configured locking, Vault Owners are still able to edit Case-related objects in these protected states.
This feature is available automatically with no additional action required.
Atomic Security Support on App Controls
Vault Safety’s app controls have been enhanced to fully support atomic security on a field by field basis. Fields that are logically grouped together will all respect the most stringent security of any of the underlying fields.
This feature is available automatically with no additional action required.
Coding
Features in this section are additions or improvements to Vault Safety coding capabilities.
Multilingual MedDRA
Central MedDRA now supports the following MedDRA Languages: Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish. This support is a back-end change to serve as a foundation for future enhancements to the MedDRA Browser, Local Case Translation, and Local Case Intake.
Admins must turn on this feature with an Admin checkbox. Enable Multilingual MedDRA provides more information.
Learn More:
Aggregate Reports
Features in this section are additions or improvements to Vault Safety Aggregate Reports.
PBRER Unmasked Cumulative SAE from Clinical Trials and Line Listings
The unmasked Cumulative SAE from Clinical Trials and Line Listing reports are now available for PBRER periodic reports. Additionally, the logic to generate masked Cumulative SAE from Clinical Trials is updated to generate blind-protected unmasked versions of tabulations in addition to the masked version.
The unmasked Cumulative SAE from Clinical Trials table is automatically generated for PBRER without any configuration. However, blind protection will be applied so that only authorized users may access unmasked versions. The "Document(s) to Generate" picklist and the "Generate Masked Document" checkbox must be configured to appear on the page layout.
Learn More:
Submissions and Distributions
Features in this section are additions or improvements to Vault Safety Submissions and Distributions.
CIOMS Enhancements
The CIOMS form will now include the following information (if available in a Case): the top priority seriousness value with each Adverse Event, Drug History, Adverse Event outcome, and the Assessment Result. Section 8-12 will now also represent the seriousness values of the whole Case and not just the primary Adverse Event.
This feature is available automatically with no additional action required.
Learn More: CIOMS I Generation Data Mapping
Generate ICH E2B R2
Vault Safety now supports exporting ICH E2B R2 submission documents. This feature includes the ability to generate E2B files with ICH-specific data elements and a new user-facing option for generating an ICH E2B R2 file.
This feature is available automatically with no additional action required.
Learn More: E2B Generation Data Mapping
ICH E2B (R3) Case Validation
Vault Safety now provides Case-level validation based on ICH E2B (R3) specifications. The validation includes over 150 ICH E2B (R3) validation rules and applies to EMA E2B R3, FDA VAERS E2B R3, and ICH E2B R3 file formats.
Admins must perform configuration to enable E2B Case Validation and Submissions.
Learn More: Case and Submission Validation
ICH E2B (R3) Submission Validation
Vault Safety now provides Submission-level validation based on ICH E2B (R3) specifications. The validation includes over 150 ICH E2B (R3) validation rules and applies to EMA E2B R3, FDA VAERS E2B R3, and ICH E2B R3 file formats.
This feature includes a change to remove the “Generate Transmission Document(s)” Entry Action from the Pending state in the Transmission lifecycle.
This feature is available automatically, but Admins must perform configuration to view validation results.
Learn More: Case and Submission Validation
Vaccine Submissions
Vault Safety 20R3 includes the following features to support report generation and submissions for vaccines.
VAERS Submission
Vault Safety now supports the capture, tracking, and submissions of ICSRs with suspect or interacting Vaccine-type products to the Food and Drug Administration (FDA). Submissions are supported through the FDA CBER VAERS Gateway, using a new FDA VAERS E2B (R2) file format.
As part of this feature, Vault Safety’s data model was extended to new fields to capture the data required for VAERS submissions.
Additional enhancements include translation of Vaccine specific object types, conditional auto-calculation of Age at Vaccination, the prevention of creating multiple Patient Contacts or Best Doctors, and the mapping of VAERS specific acknowledgments to Vault Transmission lifecycle states.
Admins must perform configuration to enable Vaccines and VAERS Submissions.
Learn More:
EMA/UK Vaccines Submission
Vault Safety now allows for the capture, tracking, and submissions of Vaccines to EMA.
Admins must perform configuration to enable Vaccines.
VAERS Combination Products Submission
Vault Safety will now support Combination Product submissions to VAERS to ensure compliance with upcoming January 2021 FDA regulations.
This includes Case Processing with vaccine-led combination products and E2B (R3) submission to VAERS with vaccine-led combination products.
Admins must perform the following configuration to enable vaccine combination products:
Learn More:
Extended Data Model for Vaccines
Vault Safety data model was extended to better capture and track vaccine-specific information.
Data model extensions include adding the Health Care Professional object type to Case Contact, adding a new text field for Reason Received Late on Case, adding a new External System UID for integrations on Case, as well as adding the Hospital Admission Date for Patient (PHI), the Hospital Discharge Date for Patient (PHI), the Conception Date for Patient (PHI), and the Pregnancy Due Date for Patient (PHI).
A new Suppress Submission Case field has also been added but does not control any functionality in this release.
Admins must perform configuration to enable Extended Data Model for Vaccines.
Masked Distribution for VAERS E2B (R3) File Format
With this release, Vault Safety has extended sensitive data protection for distributions. Sensitive FDA VAERS-specific fields are now masked in addition to the pre-existing masked fields for Distributions with Patient Content Protection (PII) Masking and/or E2B Masking turned on.
This enhancement applies to the FDA VAERS E2B (R3) file format.
Note Content protection preferences apply only to partner distributions, not reporting obligations.
Admins must turn on this feature with an Admin checkbox. This feature is controlled using the Mask PII, Mask E2B, and Mask Unblinded Content checkboxes.
Legacy vaults may need to perform additional configuration to enable masked distributions.
Learn More: Generate Masked Distributions
Email Distributions & Submission
Vault Safety now supports a new type of Transmission Profile for sending ICSR submissions and distributions via email. A cover letter template can be configured to send as part of an email transmission, and multiple recipient email addresses can be specified for each email transmission profile. Email transmissions are tracked for delivery, opening, and error for each recipient.
Admins must perform configuration to enable Email Submissions and Distributions.
Learn More:
MHRA Submission Setup (BREXIT)
Administrators can now configure Vault Safety to allow submissions to the Medicines and Healthcare products Regulatory Agency (MHRA) AS2 gateway. Submissions to the MHRA follow EMA E2B (R3) guidance and are in the EMA E2B (R3) file format.
Admins must perform configuration to move the United Kingdom out of the jurisdiction of the EMA and add it to the jurisdiction of the MHRA in addition to setting up the MHRA Gateway.
Learn More: Configure MHRA Gateway
Auto-Submissions
Vault Safety can now submit multiple ICSR files to the gateway and email destination directly from the Case. Once the reporting obligations are evaluated for a Case, you can submit at the Case level without having to navigate to each Submission/Distribution.
Admins can configure which agencies and distribution partners qualify for auto-submission at the Transmission Profile-level.
Admins must perform configuration to enable Auto-Submissions.
Learn More: Auto-Submissions
Local Region Submissions and Language Translation Support
Vault Safety now supports the ability to translate and distribute Cases to local regions. This includes the ability to add translations for text fields from a global English Case. Submissions for many languages are available by default and additional ones can be added. This feature enables global submissions to agencies, partners, ethics committees, and other organizations.
When a Case is approved, Vault Safety prepares the Case for translation with respect to reporting obligations. Localized E2B(R2) and E2B(R3) are generated including all translated text.
Admins must perform configuration to enable Localized Submissions and Translation Support.
Learn More: Prepare Local Transmissions
E2B+ SDK Extension for Custom Distribution Formats
Vault Safety now allows custom developers to extend existing E2B XML formats or create their own new text data transfer formats.
Admins must perform configuration to enable the E2B+ SDK Extension.
Add Regulatory Agencies as Standard Organizations
Vault Safety is now pre-loaded with many worldwide health authorities. In addition, Vault Safety now supports gateway submissions to Health Canada.
This feature includes a change to new gateways where the Gateway User is now required and all Vault gateway URLs will show /inboundv2/, regardless of the gateway type. These changes do not impact communication between existing gateways.
Admins must turn on this feature with an Admin checkbox. Enable Regulatory Agencies provides more information.
Learn More:
Performance and Infrastructure Enhancements
The following features are internal infrastructure enhancements to improve scalability and performance.
Vaccine Aggregates - High Volume
Vault Safety has optimized system performance for generating Periodic Reports with high volumes of cases, including vaccine cases.
This feature is available automatically with no additional action required.
High Volume Case Processing
Vault Safety now has performance tuning for a high volume of cases.
This feature is available automatically with no additional action required.
Replace Configured Unit of Measurement VQL Constraints with System Constraints
In this release, Vault Safety will further improve system performance when users create and save Case-related data. To achieve these gains, VQL criteria will be removed from Unit of Measurement fields such as Age, Height, and Duration.
These constraints will be replaced by system-managed validation that will warn users when an incorrect Unit of Measurement is selected.
This feature is available automatically with no additional action required.
Safety.AI
Vault Safety.AI 20R3 introduces the following new features.
Intake
Features in this section improve Safety.AI's intake capabilities.
Inbox Item Security and Audit Trail
Safety.AI now enforces Vault security around Inbox Items including Permission Sets, Lifecycle State, and Atomic security, to ensure only authorized users can access Inbox Items. Users must be assigned the API Vault Action permission to be able to create Inbox Item records for any sponsor organizations by calling the Intake API.
In addition, Safety.AI automatically compiles an audit trail that logs actions on Inbox Item records and sections as well as Create AER actions.
This feature is available automatically with no additional action required.
Inbox Item Date Validations
Safety.AI now prevents users from saving invalid dates and from promoting an Inbox Item to case with invalid dates. The validation rules include that dates cannot be in the future, before 01-01-1800, or later than the date of death, and that the start date cannot be before the end date for events and Dose Administration.
This feature is available automatically with no additional action required.
Learn More: Inbox Item Data Validation
Manual Inbox Item Intake
Users can manually create Inbox Items as an alternative to automated intake through the API.
This feature is available automatically with no additional action required.
Learn More: Create an Inbox Item Manually
Inbox Item Document Linking
Safety.AI automatically links the Source Document from the Intake API to the Inbox Item using the new Source Document field. Users can also manually link multiple documents to an Inbox Item using the new Document field on the Inbox Item. Documents will be automatically linked to the case when promoting an Inbox Item.
This feature is available automatically with no additional action required.
NLP and Data Extraction
Features in this section improve Safety.AI's NLP and data extraction capabilities.
Case Level Seriousness Detection For Inbox Priority
Safety.AI will now predict and suggest priority for new Inbox Items based on the Case-level seriousness from text if seriousness is not provided in structured data.
This feature is available automatically with no additional action required.
Vaccine Administration Facility and Cause of Death Intake
Safety.AI Intake API will now validate and ingest Vaccine Administration Facility and Cause of Death information. Case Contact and Cause of Death records will be generated upon promoting to Case.
This feature is available automatically with no additional action required.
Structured Case Data Intake and New Inbox Item Fields
Safety.AI Intake API can now validate and ingest case information that is not editable on the Inbox Item form, including Case Contact, Adverse Event, Case Products, Product Dosage, and Product Indication fields. These fields will be snapshot to the Case upon promoting to Case.
Safety.AI will support two new fields, Product Patient Route of Administration (RoA) and Adverse Event Outcome for structured data API intake and for verification on the Inbox Item form.
This feature is available automatically with no additional action required.
Learn More:
Human Verification Enhancements For Predictions
Dropdown fields will now be searchable to make selection easier, especially from long lists (e.g. country). In addition, Safety.AI will now automatically populate medium confidence level predictions in addition to high-level ones.
This feature is available automatically with no additional action required.
Data Verification
Features in this section improve Safety.AI's data verification capabilities.
Case Contact Intake and Classification
Vault Safety.AI API will now ingest structured contact information for reporters, patients, and other contacts. While entering and verifying data, Safety.AI allows users to classify Case Contact types, including differentiating between reporters and the patient.
This feature is available automatically with no additional action required.
Intake and Verification for New Product and Reporter Fields
Safety.AI will now support Product Indication and Lot Number intake. The Intake API will accept these fields in the JSON structured data that will be presented in Product sections of the Inbox Item user interface. Users will be able to edit and save these fields.
This feature is available automatically with no additional action required.
Product And Medical Event Classification
Safety.AI attempts to classify products (Case Product or Drug History) and medical events (Adverse Event or Medical History) to help intake users triage and verify product and event information. Users can verify and edit the product and event type when they verify the Inbox Item.
When the Inbox Item is promoted, the system creates the appropriate Case Product or Drug History records and Adverse Event or Medical History records based on the Case Product type and Event type respectively.
This feature is available automatically with no additional action required.
Case Promotion and Duplicate Detection
Features in this section improve Safety.AI's case promotion and duplicate detection capabilities.
Promote to Case from Inbox Item
Case Validity will now be checked on the Inbox Item form. After verifying the data of an inbox item, users will be able to check duplicates and promote to Case directly. Users will then automatically be redirected to the Case.
Admins must perform configuration to add the Promote to Case user action to the Inbox Item object.
