New in 21R2.4

Release Date: October 15, 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 October 21, 2021.

Email to Vault Safety Inbox Item Configuration

This feature enables customers to send emails to a Vault-owned email address and automatically create Inbox Items with the email and attachments. Vault Intake users will receive a notification when new Inbox Items are created from emails so they can start case intake.

Customers can continue to use an existing email address by setting up an auto-redirecting rule to a Vault-owned email or Vault users can send emails directly to a Vault-owned email address. Admins can define up to 50 Vault-owned email addresses and configurations associated with each email address.

Learn More: Manual Inbox Item Intake

Inbox Item Follow-Up: Pre-calculations Admin Checkbox

Vault Safety now pre-calculates and displays automatic field calculations, Combination Product Constituents, and Study Products when merging an Inbox Item to a follow-up Case version. This behavior ensures that automatically calculated fields are always up-to-date on the new follow-up Case version. This feature also introduces the Case Promotion Settings Page, where administrators can enable and configure settings for Inbox Item Follow-up.

Learn More: Inbox Item Follow-Up: Auto-Calculations

Inbox Item Intake Enhancements Auto-on

Manual intake and verification on Inbox Items is made easier with several new enhancements. Firstly, the New Info Date 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 using the Source Pane. Thirdly, the Inbox Item sections will now show a Save button instead of Verify for manual entry to differentiate that from verification of imported or extracted data. Fourthly, all the required fields will be highlighted in yellow and will not have a blank option.

Learn More:

Domestic Case Processing Configuration

Vault Safety now supports domestic case processing in a unified interface including region-specific fields. You can also view cases in your preferred language. For example, for Japanese domestic cases, the PMDA-specific fields are available for data entry in addition to the global fields on the Case screen. You can complete case processing in your chosen language, from intake through the medical review stage.

Learn More: Domestic Case Processing

MedDRA Synonyms Configuration

Vault Safety can now capture company-specific MedDRA coding preferences and speed up coding with a MedDRA Synonym list. You can manually create and edit synonyms in Vault Safety, or bulk import synonyms from an external source.

When auto-coding a MedDRA field from a reported term, Vault Safety will first search for an exact match to an active MedDRA Synonym. If no exact match is found, the system will search the MedDRA dictionary for a matching term.

Learn More: Manage MedDRA Synonyms

Japan PMDA Gateway Submission Configuration

Vault Safety now supports AS2 gateway submission settings for Japan Pharmaceuticals and Medical Devices Agency (PMDA) ICSR submissions in the PMDA E2B (R3) file format.

Learn More:

Japan PMDA Submission Rules Configuration

A new standard reporting rule set is now available for PMDA ICSR Submissions. If the system identifies a Japanese Product or Study Registration in a Case as reportable to PMDA, a submission record for the PMDA will be scheduled based on the reporting rules.

Learn More: Reporting Rule Sets

PMDA E2B(R3) Submission Validation Auto-on

This feature introduces full PMDA E2B(R3) conformance rules and extends the ICH E2B(R3) validation capabilities delivered in 20R3. Validation is automatic when an ICSR submission in PMDA E2B(R3) file format is generated or regenerated for a reporting destination. PMDA E2B(R3) regional validation can be triggered at the Case level using the Evaluate Regulatory Conformance user action. Validation Result records are created based on each evaluated Validation Criteria and can have an outcome of Pass, Fail, or Warning.

Learn More: Case and Submission Validation

Japan PMDA E2B(R3) Export Auto-on

Vault Safety now supports PMDA E2B(R3) export files for individual cases.

Learn More: PMDA E2B(R3) Mapping

Expectedness in Periodic Reports (RSI) Configuration

Vault Safety now supports evaluating adverse event expectedness within a specific time period, to accurately identify SUSARs in periodic reports. In a Product Datasheet, you can specify the approval date range for each term. When generating a DSUR, PBRER, or PSUR, you can select the relevant Product Datasheet version to evaluate term expectedness in periodic reports.

Learn More:

AER Extraction from Email Attachments to Inbox Item Configuration

Vault Safety.AI will now automatically extract case information from EML and MSG email files. Intake users can start the extraction process from an email file and attachments with Viewable PDF Renditions. Upon successful completion, the system creates a single Inbox Item linked to the email and attachments.

Intake API Using JSON Object

The Intake JSON endpoint now accepts JSON passed through as text in the request body.

To support this capability, two new body requests can be used in addition to the existing one:

  • multipart/form-data: To pass JSON text in the intake_json parameter when passing another document in the intake_form parameter
  • application/json: To only pass JSON text as raw content

Learn More: Vault Developer Portal: Intake JSON