Release Date: September 24, 2021
We are pleased to bring you the following new functionality in this week’s release. See details about feature enablement below.
Safety
Safety features are targeted for tentative availability on September 30, 2021.
Intake Enhancements on Inbox Item Auto-on
Manual intake and verification on Inbox Items is made easier with two new enhancements. Firstly, a New Info Date field will now be available in the Inbox grid to sort new Inbox Items by date and easily identify late Cases. Secondly, the display for imported long text fields (such as Case Narratives) is now wider to facilitate the verification of long text.
Most Conservative Product and Assessment Evaluation per Region Rules Configuration
Vault Safety administrators can now optionally configure reporting rule sets to evaluate rules against the most conservative Case Product and Case Assessment, when there are multiple suspect or interacting Case Products registered to a given reporting destination. Seriousness, expectedness, relatedness, and the drug role of the related Case Products are all considered when determining the most conservative Case Product and Case Assessment. Unless configured otherwise, pre-existing rule sets, such as the FDA and EMA ICSR rule sets, continue to evaluate rules based on the primary Case Product and Case Assessment.
In addition, when this feature is configured in a rule set, Vault Safety evaluates the “AE in Jurisdiction” rule parameter using the country specified on the primary Reporter Case Contact instead of the country on the primary Case Adverse Event. This is to align with ICH guidelines.
Learn More: Configure Reporting Rules Product Selection
Configurable Field Masking Exceptions for Masked Distributions: Blank, Sex, and Country Configuration
When turning on Patient Content Protection, Vault Safety now supports configurable field masking for blank fields, Reporter Country, Parent Sex, and Patient Sex. You can now pre-configure which of these PII / maskable E2B fields should be unmasked, while the remaining fields stay masked. In addition, when the Date of Birth field is masked, the system still populates the Age and Age Group field values during ICSR report generation, if available. This will be supported for all ICSR outputs, including E2B and PDF forms.
Learn More: Generate Masked Distributions: Exceptions to Patient Content Protection
ISO 8859-1 Validations for FDA E2B(R2) Configuration
Vault Safety now validates FDA E2B(R2) submission documents for character encoding. FDA E2B(R2) follows the ISO 8859-1 standard, which does not support UTF-encoded characters. An E2B(R2) Transmission with UTF-encoded characters bound for the FDA CBER or CDER gateway will now trigger validation errors and warnings. Furthermore, the system will automatically convert some UTF-encoded characters that map to ISO 8859-1.
Learn More: FDA Character Encoding Validation
MHRA E2B(R2) Dose Form Codes Auto-on
Vault Safety’s Dose Forms dictionary now supports the full list of approximately 400 MHRA Dose Forms, including their corresponding 1 to 3 digit codes. Encoded dose forms in E2B(R2) reports received from the MHRA and imported into Vault Safety will be mapped using the new dictionary entries.
Learn More: Enter Case Data: Dosages Section
Intake JSON API for Safety Customers
Vault Safety can now ingest calls from the Safety Intake AI endpoint to receive an Inbox Item from a JSON file:
POST /api/{version}/app/safety/ai/intake
Vaults no longer require Safety.AI to receive calls from this endpoint. Vaults without Safety.AI only support processing structured data (JSON). The system ignores unstructured data.
Learn More:
Feature Enablement Changes
Note the following feature with enablement changes in this release:
| Feature | Previous Enablement | New Enablement |
|---|---|---|
| PT Aggregation in Periodic Reports | Auto-On (21R2.2) | Support (21R2.3) |
Read more about this feature in New in 21R2.2.