Safety Feature Enablement Overview

Learn how to update your Vault’s configuration to enable Vault Safety features.

When Vault Safety Suite releases an update, new features may require changes to your Vault’s configuration to be available to end users. The following sections provide information for Admins to make features available for use:

Enable Case Intake Features

Release Added or Changed Feature
24R3 Updated Sender-Based Email Attachment Handling
24R3 Updated E2B Import to Inbox Item
24R3 Updated Inbox Items
24R2 Automated Classification of Inbox Item Significance
24R2 Product Coding: Additional Matching Fields for Product Aliases
24R1 Sender-Based Inbound Validations
24R1 Safety Inbox Loader Multi-Case Tabular Data Import
23R3 Case Access by Local PV Email
23R2 Non-E2B Case Identifiers Entry and Duplicate Search
23R2 Automated Case Promotion for Non-Cases
23R2 Multi-Product Selector for Study Products on Inbox Items
23R2 Company Product Match Verification
23R2 Pregnancy Case Intake
23R2 Promoting an Inbox Item to Multiple Cases
23R1 PHI and PII Masking on the Potential Matches Page
23R1 Local Case Import
22R3 Inbox Item Follow-Up Case Compare
22R3 Merge to In-Flight Case
22R1 Automated Case Promotion
22R1 Organized Data Collection
22R1 Field Limit Updates for E2B
21R1 Manual Study Intake on Inbox Item

Enable Case Processing Features

Release Added or Changed Feature
24R3 New Case-Level Reportability Indicator
24R3 New Datasheet Expectedness for Blinded Study Products
24R3 New Case Copy with Linking
24R3 New Copy Datasheet Expectedness Justification to Case Assessments
24R3 New Duplicate Detection During Case Processing
24R3 New Multi-Product Selector for Study Products on Cases
24R3 New Import Online Questionnaire Responses to Follow-Up Inbox Items
24R3 Updated QC Checklist Generation
24R2 Online Questionnair​​es for Post-Marketing Follow-Ups
24R2 Agency-Based Auto-Expectedness for Clinical Trial Study Cases
24R2 Show Calculation Basis for Clinical Trial Study Expectedness
24R2 Product Browser for Faster Case Product Selection
24R2 Case Version Compare with Summary
24R2 Clinical Trials: Isolate Blinded Product Information
24R1 Datasheet Expectedness by Age and Sex
24R1 Update to Seriousness Picklist
23R3 Product Family Datasheets
23R3 Case Assignment
23R3 Case Volume Metrics
23R3 Auto-Population of Case Product Registration Holder
23R2 Product Masking Selection for Study Products
23R2 Study Product Expectedness
23R2 Clear Radio Button Selection for Submittable Fields
23R2 Asynchronous Activity Indicators - Validation Results
23R2 Generate Assessment Records Action
22R3 Remedial Actions and Malfunction for Combination Products
22R3 Automatic Email of Case Questionnaire & Scheduled Reminders
22R3 Over-the-Counter (OTC) Drugs, Cosmetics, Nutritionals, and Non-Physical Devices
22R2 Narrative Templates for Report Types and Studies
22R2 Auto-Calculation Override
22R2 Partial Date Support for Dose-Level Expiration
22R2 Partial Dates for Case Product Device Fields
22R1 Listedness and Expectedness From Core Datasheets
22R1 Conditional Expectedness
22R1 Control Workflow Transitions for Case Validations
22R1 Case Nullification
22R1 Adverse Event Watchlists
21R1 Pregnancy and Parent-Child Case Data Collection
20R2 Medical Review Timeline
20R2 Manual Case Locking: User Check In and Check Out
20R1 Case Product Dose and Indication Sections
20R1 xEVMPD Dosage Forms and Non-Standard Dose Units
20R1 Case Level Relatedness and Automatic SUSAR/SAE Tagging

Enable Localization and Translation Features

Release Added or Changed Feature
24R3 New Localized Cases: Global Narrative Override on Follow-ups
24R2 PMDA E2B(R3): Export Substance Codes from JDrug Codes
24R2 Japan Domestic Case: Calculate Due Dates for Localized Case Assessments
24R1 PMDA Local Reporting Details Generation and Submission Linking
23R3 PMDA Clinical Trial Reporting Enhancements
23R3 PMDA Due Dates Based on Localized Case Assessments
23R2 PMDA Local Case Processing Automations
23R2 PMDA Special Report Classification for Case Processing
23R2 Local Receipt Date Overrides
23R1 Auto-Translation Framework for Localized Intake and Case Submissions
22R2.0.2 Localized Record Deletion
22R2.0.2 Domestic Case Processing for Agency Jurisdictions
21R3 Domestic Case Processing
21R2 Local Language to English Intake
21R2 Localized Submissions and Translation Support
21R2 Local Fields for NMPA (China)
21R2 Local Fields for MFDS (Korea)
21R2 Local Fields for PMDA (Japan)

Enable Coding Dictionary Features

Release Added or Changed Feature
24R3 New JDrug and WHODrug Cross Reference Tool
24R3 New Licensing Check for MedDRA
24R3 Updated MedDRA Bulk Recode Cases
24R2 Faster Company Product Selection on Inbox Item
24R1 Manage Custom Dose Forms, Routes of Administration, and Units of Measurement
23R3 Hierarchical MedDRA Terms for Datasheets and Watchlists
23R3 MedDRA Query Building Blocks
23R3 Japan Drug Dictionary (JDD)
23R3 MedDRA UI Enhancements for Non-Case Coding
23R2 Smart MedDRA Coding
23R1 Automatic MedDRA Hierarchy Updates
22R3 MedDRA Synonym Field Exclusion and Candidate Auto-Creation
22R3 IMDRF Dictionary for Maintenance, Case Processing, and Submissions
22R2 Support for Unconstrained UCUM for Test Result Units
22R1 MedDRA Hierarchy Updates for CMQ and Vault Reporting
21R3 MedDRA Synonyms
21R2 Multilingual MedDRA
20R1 Standardized and Custom MedDRA Queries
20R1 MedDRA Auto-Coding

Enable Reporting Rules Features

Release Added or Changed Feature
24R3 New Country Specific IMP ICSR Reporting
24R2 Product Family Rule Parameter
24R1 Japan One Last Time Reporting
24R1 Safety Data Validation Exception Handling
24R1 Inactivate Product & Study Registrations
23R3 Extend Definition of Suspect to Drug Not Administered
23R3 Configurable Substance Matching for Cross Reporting
23R3 Cross Reporting without Expectedness Substitution
23R2 One Last Time Reporting for All Destinations
23R2 Rule Engine Destination Evaluation Log
23R2 PMDA Submission Rule Parameter Updates
23R1 Company Product Type
22R2 Cross Reporting Most Conservative Submission
22R2 Partner Distribution Jurisdictions
22R1 Automated Cross Reporting
22R1 Support for MedDRA Queries in Submission Rules
21R3 PMDA (Japan) Submission Rules

Enable Submissions and Distributions Features

Release Added or Changed Feature
24R3 New MFDS E2B(R3)
24R3 New FDA MedWatch 3500A: August 2024 Version
24R3 New Select Registrations on Submissions
24R3 New Literature E2B Retransmission
24R3 New E2B Readable Renditions
24R3 New Configurable PII and E2B Masking for NullFlavor Fields
24R2 Transmission Output Templates
24R2 Static IPs for AS2 Vault URLs in AS2 Connections
24R2 AS2 Connection Troubleshooting Tools
24R2 PMDA: Blinded Study Product Reporting
24R2 Configurable From Email Addresses for Transmissions
24R2 Strict Transmission Version Enforcement
24R2 Reporting Family Configuration Scenarios
24R2 PMDA E2B(R3): Prevent Export of Unsupported UCUM Codes
24R2 Transmission Profiles for FDA E2B(R3) Submissions and Distributions
23R3 AS2 Connections
23R3 Mask Dosage in Blinded Distributions
23R3 Case-Level Nullification and Amendment Reasons for Transmissions
23R3 Export Product (Reported) to CIOMS I and FDA 3500A
23R3 Show Unmasked Open-Label Products on Blinded Forms
23R3 Use Adverse Event PT on CIOMS and MedWatch 3500A
23R3 EMA Clinical Trial Submissions: Non-Study Suspect Products
23R2 Logical Deletion of Non-Submittable Transmissions on Subsequent Evaluation
23R2 IMDRF on FDA MedWatch 3500A
23R2 FDA MedWatch 3500A Support for OTC and Additional Device Fields
23R1 PMDA Multi-Submission with Localized Case
22R3 Async Submit to Gateway
22R2.0.2 Exclude Attachments and Literature Documents
22R2 Receiver Information Export for E2B(R2) & PMDA E2B(R3)
22R2 Multi-Format Submissions & Distributions
22R2 Case Data Validations and Always Evaluate Criteria
22R1 Safety Report Version Customization
22R1 Ignore Validation Rule
21R3 PMDA E2B(R3) Export
21R3 Most Conservative Product and Assessment Evaluation per Region Rules
21R3 Configurable Field Masking for Blank Fields, Country, and Sex
21R2 EMA Certification Enhancements (Name Parts and RoA Prioritization)
21R2 Default Sender User
21R1 Suppress Submissions
21R1 E2B Case Validation and Submissions
20R3 Auto-Submissions
20R3 Email Submissions and Distributions
20R3 Regulatory Agencies as Standard Organizations
20R1 Masked Content Distributions

Enable Aggregate and Periodic Reporting Features

Release Added or Changed Feature
24R3 Updated CIOMS II Line Listings
24R2 Japan Periodic Reporting: Post-Market Serious (J-PSR)
24R1 Japan Periodic Reporting - Post-Market Non-Serious (NUPR)
24R1 Generating Tabulations Using Aggregate Report Sections in Vault Safety
23R3 Enhanced SAR Line Listing Review for DSUR and PBRER
23R3 PSUR Summary Totals and Separate Log Files
23R3 DSUR and PBRER Summary Totals and Separate Log Files
23R3 Criteria Page on Aggregate Reports
23R3 Turn Off Narrative Preview for CIOMS II Reports
23R2 Investigational Product Causality for DSUR and PBRER
23R2 List All Suspect Products for DSUR and PBRER
23R2 Drug Role Filtering for DSUR and PBRER
23R2 Interval Case Listing for Aggregate Reports
23R1 PADER Authoring and Table Generation
21R3 Expectedness in Aggregate Reports
21R1 Filter Cases by Approval Date in Aggregate Reports
21R1 PSUR Cumulative Tabulations and CIOMS II Line Listings
20R2 DSUR Appendices and Masked DSUR Reports
20R2 XLSX Aggregate Report Templates

Enable Case and Safety Report Collections Features

Release Added or Changed Feature
24R1 Create and Export Case and Safety Report Collections

Enable Product Administration Features

Release Added or Changed Feature
23R2 New Substance Name Field in Product Library
22R3 Product Hierarchy Data Model: Product Families and Inactive Ingredients
21R1 Vaccines and VAERS Submissions
20R2 Combination Products
20R2 Product Substances

Enable Study Administration Features

Release Added or Changed Feature
24R3 Bulk Unblind Studies with Isolate Blinded Product Information
23R2 Study Site Reporter
22R1 Bulk Unblind Studies
21R1 Postmarket Studies
20R1 Study Arms and Blinded Product Names

Enable Controlled Vocabulary Administration Features

Release Added or Changed Feature
20R2 Deprecated Controlled Vocabulary User Actions
20R1 Controlled Vocabulary User Actions

Enable Users & Groups Features

Release Added or Changed Feature
24R1 Case Access Group Security

Enable Vault to Vault Connections Features

Release Added or Changed Feature
24R3 Updated Safety-EDC Vault Connection
24R2 Safety-RIM Vault Connection
24R1 Safety-Clinical Operations Vault Connection: Safety Letters
24R1 Medical-Safety Vault Connection

Enable PMDA-Related Features

From the features listed above, the following table specifies features that support intake and Case processing for Japan and reporting to the PMDA. Depending on which version of Vault Safety you created your Vault from, some configuration may already be complete.

Release Added or Changed Feature
24R3 New JDrug and WHODrug Cross Reference Tool
24R3 New Copy Datasheet Expectedness Justification to Case Assessments
24R2 Japan Periodic Reporting: Post-Market Serious (J-PSR)
24R2 PMDA: Blinded Study Product Reporting
24R2 PMDA E2B(R3): Export Substance Codes from JDrug Codes
24R2 Japan Domestic Case: Calculate Due Dates for Localized Case Assessments
24R2 PMDA E2B(R3): Prevent Export of Unsupported UCUM Codes
24R1 Japan Periodic Reporting - Post-Market Non-Serious (NUPR)
24R1 Japan One Last Time Reporting
24R1 PMDA Local Reporting Details Generation and Submission Linking
23R3 Japan Drug Dictionary (JDD)
23R3 PMDA Clinical Trial Reporting Enhancements
23R3 PMDA Due Dates Based on Localized Case Assessments
23R2 PMDA Submission Rule Parameter Updates
23R2 Local Receipt Date Overrides
23R2 PMDA Local Case Processing Automations
23R2 PMDA Special Report Classification for Case Processing
23R1 PMDA Multi-Submission with Localized Case
23R1 Auto-Translation Framework for Localized Intake and Case Submissions
23R1 Local Case Import
22R2.0.2 Localized Record Deletion
22R2.0.2 Domestic Case Processing for Agency Jurisdictions
22R2 Receiver Information Export for E2B(R2) & PMDA E2B(R3)
21R3 PMDA (Japan) Submission Rules
21R3 Domestic Case Processing
21R3 PMDA E2B(R3) Export
21R2 Multilingual MedDRA
21R2 Local Language to English Intake
21R2 Local Fields for PMDA (Japan)
21R2 Localized Submissions and Translation Support