21R3 New Features

Learn about new features and feature enablement in 21R3.

Last Updated

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 21R3. For details about new features in the Vault Platform in 21R3, see the Vault Release Notes.

Intake

Features in this section are additions or improvements to Vault Safety case intake.

Inbox Item Follow Up

Admin Checkbox

When promoting an Inbox Item, duplicate detection now presents an option to create a Follow-Up Case that compares all the data on the previous Case version with the new data on the Inbox Item. Users can select any information they want to update based on the Inbox Item. Upon Case promotion, the system merges the data from the previous Case version and the Inbox Item. This feature supports Inbox Item passthrough fields received through the API and atomic security on fields from the previous Case version.

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Inbox Item Follow-Up: Pre-calculations

Auto-On

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.

Note This feature is auto-on if Inbox Item Follow-Up has been enabled in your vault.

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Email to Vault Safety Inbox Item

Config

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-forwarding 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.

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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.

Note Auto-On for vaults using Inbox Items.

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Case Processing

Features in this section are additions or improvements to Vault Safety case processing.

Auto-Expectedness Roll Up Changes

Auto-On

This enhancement delivers updated logic to ensure that overriding expectedness on a Case Assessment does not prevent the Case-level Expectedness field from updating to match the primary Case Assessment, unless the Case-level Expectedness field has been explicitly overridden.

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Domestic Case Processing

Config

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.

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Coding

Features in this section are additions or improvements to Vault Safety coding capabilities.

MedDRA Synonyms

Config

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.

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Submissions and Distributions

Features in this section are additions or improvements to Vault Safety report generation and transmission capabilities.

Most Conservative Product and Assessment Evaluation per Region Rules

Config

Vault Safety administrators can now optionally configure reporting rule sets to evaluate rules against the most conservative Case Product and Case Assessment, which is especially useful 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.

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Configurable Field Masking Exceptions for Masked Distributions: Blank, Sex, and Country

Config

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.

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ISO 8859-1 Validations for FDA E2B(R2)

Auto-On

Vault Safety will now validate FDA E2B(R2) submission documents for character encoding and automatically replace UTF-encoded characters with their ISO 8859-1 equivalent, or replace them with a space if there is no equivalent. FDA E2B(R2) follows the ISO 8859-1 standard, which doesn’t support UTF-encoded characters. When a Case contains UTF-encoded characters, Transmissions to FDA CBER or CDER in E2B(R2) format trigger validation errors or warnings.

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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. When Vault Safety imports an E2B(R2) file containing encoded MHRA dose forms, the system maps the data to the new Dose Form dictionary entries.

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Japan PMDA Gateway Submission

Config

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.

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Japan PMDA Submission Rules

Config

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.

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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.

Note Auto-On if the E2B Case and Submission Validation features (introduced in 20R3) are already configured in your vault. Otherwise, this feature requires configuration. The PMDA Submission Rules feature must also be configured to enable the Re-evaluate Reporting Obligations user action and, consequently, the automatic re-evaluation of submission records during local case processing.

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Japan PMDA E2B(R3) Export

Auto-On

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

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Aggregate Reports

Features in this section are additions or improvements to Vault Safety Aggregate Reports.

PT Aggregation in Periodic Reports

Support

This feature provides the option to count only unique instances of Preferred Terms (PT) per Case for summary tabulations in periodic reports. When enabled, if a Case contains multiple Case Adverse Events coded under the same PT, the report counts a single PT event instead of multiple events. This feature impacts the DSUR and PBRER Cumulative Tabulation of Serious Adverse Events From Clinical Trials; DSUR Appendix Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials; PBRER Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources; PSUR Summary Tabulations; and PADER Summary of ADR from Postmarketing Sources. Unless this feature is enabled, the system continues to count each Case Adverse Event separately.

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Expectedness in Periodic Reports (RSI)

Config

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.

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Integrations

Features in this section are new integrations with Vault Safety or enhancements to existing integrations.

Intake JSON API for Safety Customers

N/A

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.

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Intake API Using JSON Object

N/A

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

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Safety Automation Intelligence

Features in this section are additions or improvements to Vault Safety Automation.

Automatic Case Intake from Uploaded Email

Config

Vault Safety Automation 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.

Note Auto-on for Safety Automation customers who have configured the Create Inbox Item action and enabled Attachments on the Document Type.