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 21R2. For details about new features in the Vault Platform in 21R2, see the Vault Release Notes.
Safety
Vault Safety 21R2 introduces the following new features.
System
Features in this section are changes or improvements to the Vault Safety system.
Vault UI Refresh Changes
Auto-OnVault Safety now includes icons for all system actions that can be displayed in the Action UI. The application has been updated to reflect Vault Platform’s new look.
Learn More: About the Action Bar and All Actions Menu
Intake
Features in this section are additions or improvements to Vault Safety case intake.
Local to English Language Intake
ConfigVault Safety now supports case intake from the local language to English through the Inbox Item, provided in the new Inbox. For example, the EMA requires English submissions. If an adverse event is reported from Holland in Dutch, you can enter the Inbox Item in Dutch while translating the data to English before promoting it to a Case.
Note As of 21R2, AERs will enter a sunset period. No new functionality will be added to AERs. Using the new Inbox (Inbox Item) is optional in 21R2 (August 2021), recommended in 21R3 (December 2021), and mandatory by 22R3 (December 2022).
Learn More:
E2B R2 and R3 Import to Inbox Item
ConfigVault Safety now supports the ability to import single-case and multi-case XML files in E2B(R2) and (R3) formats to Inbox Items. The system performs an E2B import upon receiving an AS2 gateway transmission, or when a user runs the import action from an E2B document in the vault library. The Inbox Item displays the mapped E2B source data for the Case, Patient, Reporter, Adverse Events, Case Products, and Medical and Drug History in the Source Data pane. This feature also benefits from Vault Safety’s existing import to AER capabilities, including Study and Product matching, data mapping, and literature and attachments import.
Note As of 21R2, AERs will enter a sunset period. No new functionality will be added to AERs. Using the new Inbox (Inbox Item) is optional in 21R2 (August 2021), recommended in 21R3 (December 2021), and mandatory by 22R3 (December 2022).
Note This feature is auto-on for Safety.AI customers who are already using the Create Inbox Item action released in 21R1 for form intake.
Learn More:
- Enable E2B Import to Inbox Item
- Case Intake Overview: Case Intake Using an Inbox Item
- Import an Inbox Item
- E2B Case Import Data Mapping
E2B Imported Case Naming and Versioning
Auto-OnImported Cases created from E2B are now named by their Unique Identifier (UID). This will map from C.1.1 in E2B(R3). Newly created Imported Cases will default to version 0.1. Existing Imported Cases will not be modified.
Learn More: Configure Object Naming Conventions: Naming Conventions for Imported Cases
Case Processing
Features in this section are additions or improvements to Vault Safety case processing.
China (NMPA) Local Fields
ConfigChinese local data elements required by NMPA (China regulatory authority) are now available for data entry.
Learn More:
Provision Additional EMA Supported Units of Measurement
Auto-OnVault Safety now includes a full list of units of measurement supported by EMA E2B(R3).
Learn More: About the Case Page: Units of Measurement
Support Substance Decimal Places
Auto-OnCase Product Substance Strength now supports up to 4 decimal places of precision. E2B export will truncate at the appropriate number of characters.
Coding
Features in this section are additions or improvements to Vault Safety coding capabilities.
Multilingual MedDRA Browser and Autocode
ConfigThe Vault Safety MedDRA browser now offers the ability to code Adverse Events in any non-English MedDRA supported language. This capability also extends to auto-coding. The updated browser is available for Inbox Items during intake, and Case Adverse Events during subsequent case processing.
Learn More:
Multilingual MedDRA: Japanese
ConfigVault Safety Inbox Items now support the ability to browse, search, and auto-code MedDRA terms in Japanese. When the MedDRA control language is set to Japanese, the MedDRA browser filters out non-current Japanese terms by default.
Learn More:
E2B Import: Match Non-Current MedDRA in Central
Auto-OnVault Safety now supports coding non-current terms using central MedDRA when importing E2B files that contain non-current terms. A ‘Recode’ badge is displayed to remind users when a coded term is non-current. Also, the Case MedDRA Version of promoted cases from AER or Inbox Item is now set by the Active MedDRA version on the user’s vault.
Note This feature is auto-on for customers who are using Central MedDRA.
Learn More: Import Inbox Item: Auto-Code Non-Current MedDRA Terms
Aggregate Reports
Features in this section are additions or improvements to Vault Safety Aggregate Reports.
DSUR — Extended Definition of Death
Auto-OnIn Vault Safety, the List of Subjects Who Died During the Reporting Period Appendix now lists only the latest version of a fatal case received or approved during the reporting period, based on the value selected in the DSUR “Filter Case by” field. The appendix table constraints have also been updated to consider additional criteria for more accurate fatal case identification.
Note This feature is auto-on for customers who have DSUR appendices enabled. Previously generated DSURs need to be regenerated to see the update.
Learn More: DSUR Table Data Mapping: List of Subjects Who Died During the Reporting Period
Submissions and Distributions
Features in this section are additions or improvements to Vault Safety Submissions and Distributions.
Default Sender User by Destination
ConfigAdministrators can now configure a default sender user on all Transmission Profiles to be populated on system generated transmissions. For example, this allows defaulting different QPPVs for EMA and MHRA.
Learn More: Enable Default Sender User on Transmissions from a Transmission Profile
EMA Certification: Name Parts and RoA Prioritization
Auto-OnVault Safety now supports the import and export of EMA Product Name Parts. New fields for Product Name Parts are now available during Case Product data entry. EMA E2B(R3) file exports also prioritizes structured G.k.4.r.10.2a/b data over unstructured G.k.4.r.10.1 data for the Route of Administration.
Learn More:
- Enable EMA Certification Enhancements (Name Parts and RoA Prioritization)
- Enter Case Data: Case Product Details Section
- Enter Case Data: Case Drug History Section
- EMA E2B Generation Data Mapping
- E2B Case Import Data Mapping
Case level regional validation for VAERS and EMA/MHRA E2B R3
Auto-OnUsers can evaluate and review regional FDA VAERS and EMA E2B(R3) Validation Results at the Case level. The FDA VAERS and EMA regional rules are now evaluated when the Evaluate Regulatory Conformance action runs on the Case. Regional Validation Results are displayed on the Case, alongside the ICH (global) Validation Results.
Note This feature is auto-on for customers who have the Evaluate Regulatory Conformance user action enabled for the Case object. An admin must configure the action on the appropriate lifecycle state for the Case object.
Learn More: Case and Submission Validation
Replace UTF Smart Quotes with ASCII Straight Quotes in FDA E2B(R2)
Auto-OnVault Safety now converts smart quote characters to straight quote characters when generating FDA E2B(R2) submissions. This will ensure the generated ICSR continues to be ISO 8859-1 compliant, as ISO is the only encoding supported for FDA E2B(R2) submissions. Related to this, Health Canada E2B(R2) submissions will now generate in UTF instead of ISO encoding (both are supported by Health Canada) to circumvent the aforementioned issue.
Generate E2B Message ID for Manually Created Transmission
Auto-OnVault Safety will now auto-generate an E2B Message ID for a manually-created E2B submission / distribution. This identifier maps to a mandatory E2B field that facilitates the subsequent receipt of acknowledgments. Failure to submit an E2B with this identifier may result in submission failure. Now, users will no longer need to remember to enter this identifier for a manually created transmission.
Note This feature is auto-on for customers submitting E2Bs to an AS2 gateway.
FDA E2B R2 — Support “FDA Safety Report Type” (A.1.FDA.16) Field For Post Market
SupportVault Safety now supports adding the FDA Safety Report Type (A.1.FDA.16) element to FDA E2B(R2) Transmissions. This feature only impacts the Transmission file format FDA E2B(R2). This feature only supports postmarket submissions (E2B Code=3). Other IND Safety Report tags are not yet supported. This field will only be populated for post market cases and will not be present for study Cases.
Learn More:
Integrations
Features in this section are new integrations with Vault Safety or enhancements to existing integrations.
New Safety Intake API
Auto-OnThe Vault Safety API has been extended with new endpoints to receive E2B files and import to either Imported Cases or Inbox Items. New endpoints have also been introduced for retrieving import status and ACKs.
Learn More: Vault Developer Portal: Safety Intake
E2B (Plus) Import SDK Extension for Custom Import Formats
ConfigVault Safety now allows developers to extend existing E2B XML formats or create their own XML data transfer formats for inbound ICSRs. Different Inbound and Outbound E2B formats can be configured on AS2 and System Gateways.
Feature Enablement Changes
Features in this section have an enablement change in 21R2.
| Feature | Previous Enablement | New Enablement (21R2) |
|---|---|---|
| Configurable Back Reporting | Support (21R1) | Auto-On |
| Multi-Case E2B Import via API/AS2 | Support (21R1) | Auto-On |
| VAERS Certification Enhancements | Support (21R1) | Auto-On |
Safety.AI
Vault Safety.AI 21R2 introduces the following new features.
NLP and Data Extraction
Features in this section improve Safety.AI's NLP and data extraction capabilities.
Automatic Intake From Documents With a Viewable PDF Rendition
Auto-OnSafety.AI’s automatic PDF form intake feature is now available for all file formats supported in Vault including Word and image files. This will allow users to start the extraction process from any Vault Document with a Viewable PDF Rendition. Upon successful completion, an Inbox Item will be created with the case information extracted from the document text, fields, and checkboxes.
New Checkbox Recognition from Documents
Auto-OnSafety.AI will automatically extract additional information from document checkboxes including Outcome, Report Type, Patient Gender, and Age Group. Adverse Event Outcome and Seriousness will be suggested from Case Outcome and Seriousness. The Source Data pane will display this information to facilitate human verification. Safety.AI will also display a value only once in the field’s dropdown menu if it was found multiple times in the source text.
Deprecate Create AER Action
Auto-OnThe Create AER user action was replaced in 20R2 by Create Case to allow users to promote an Inbox Item directly to Case without creating an AER record. The Create AER action is being deprecated in 21R2.
System
Features in this section are changes or improvements to the Vault Safety.AI system.
AI Service with no Vault Connections
Auto-OnConfiguration is no longer required to connect to the AI Service when setting up a new Vault with Safety.AI. Previously, an administrator had to create an External Vault Connection.
