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 administrators to make features available for use.
- Case Intake
Release Added or Changed Feature 22R1 New Automated Case Promotion
22R1 New Promote an Inbox Item to Multiple Cases
22R1 New Merge to In-Flight Case
22R1 New Organized Data Collection
22R1 New Field Limit Updates for E2B
21R3 Inbox Item Follow-Up Case Compare
21R2 Updated E2B Import to Inbox Item
21R1 Manual Study Intake on Inbox Item
20R3 Updated Inbox Items
- Case Processing
Release Added or Changed Feature 22R1 New Listedness and Expectedness From Core Datasheets
22R1 New Conditional Expectedness
22R1 New Control Workflow Transitions for Case Validations
22R1 New Case Nullification
22R1 Updated Adverse Event Watchlists
21R1 Pregnancy and Parent-Child Case Data Collection
20R3 Automatic Email of Case Questionnaire & Scheduled Reminders
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
- Localization and Translation
Release Added or Changed Feature 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)
- Coding Dictionaries
Release Added or Changed Feature 22R1.0.7 New Enable EDQM Mapping for Dose Form and Routes of Administration Terms
22R1 New Enable MedDRA Hierarchy Updates for CMQ and Vault Reporting
21R3 MedDRA Synonyms
21R2 Multilingual MedDRA
20R1 Standardized and Custom MedDRA Queries
20R1 MedDRA Auto-Coding
- Reporting Rules
Release Added or Changed Feature 22R1 New Automated Cross Reporting
22R1 New Support for MedDRA Queries in Submission Rules
21R3 Enable PMDA (Japan) Submission Rules
- Submissions and Distributions
Release Added or Changed Feature 22R1 New Safety Report Version Customization
22R1 New 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
- Aggregate and Periodic Reporting
Release Added or Changed Feature 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
21R1 PADER Authoring and Table Generation
- Product Administration
Release Added or Changed Feature 21R1 Vaccines and VAERS Submissions
20R2 Combination Products
20R2 Product Substances
- Study Administration
Release Added or Changed Feature 22R1 New Bulk Unblind Studies
21R1 Postmarket Studies
20R1 Study Arms and Blinded Product Names
20R1 Study Site Reporter
- Controlled Vocabulary Administration
Release Added or Changed Feature 20R2 Deprecated Controlled Vocabulary User Actions
20R1 Controlled Vocabulary User Actions
