Safety Feature Enablement

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

Last Updated Jul 4, 2024

Note Beginning with 24R2 in August 2024, this site will no longer be available. The new Vault Safety Help site is the official site for all Vault Safety Help content. For the latest information, visit the new site.

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.

---

Expand All | Collapse All

• Case Intake

  Release Added or Changed	Feature
  23R3	Safety Inbox Loader Multi-Case CSV 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	Promote 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
  21R2	E2B Import to Inbox Item
  21R1	Manual Study Intake on Inbox Item
  20R3	Inbox Items

• Case Processing

  Release Added or Changed	Feature
  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 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

• Localization and Translation

  Release Added or Changed	Feature
  23R3	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)

• Coding Dictionaries

  Release Added or Changed	Feature
  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	Faster Company Product Selection on Inbox Item
  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
  22R3	MedDRA Bulk Recode Cases
  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

• Reporting Rules

  Release Added or Changed	Feature
  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

• Submissions and Distributions

  Release Added or Changed	Feature
  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

• Aggregate and Periodic Reporting

  Release Added or Changed	Feature
  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
  22R2	CIOMS II Line Listings
  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

• Product Administration

  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

• Study Administration

  Release Added or Changed	Feature
  23R2	Study Site Reporter
  22R1	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

• Users & Groups

  Release Added or Changed	Feature
  23R2	Case Access Group Security

• Vault to Vault Connections

  Release Added or Changed	Feature
  23R3	Safety-RIM Vault Connection

---