Safety Feature Enablement

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

Last Updated Mar 24, 2023

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.

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• Case Intake

  Release Added or Changed	Feature
  22R3 Updated	Inbox Item Follow-Up Case Compare
  22R3 Updated	Merge to In-Flight Case
  22R1	Automated Case Promotion
  22R1	Promote an Inbox Item to Multiple Cases
  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
  23R1 New	Generate Assessment Records Action
  22R3	Remedial Actions and Malfunction for Combination Products
  22R3 Updated	Automatic Email of Case Questionnaire & Scheduled Reminders
  22R3	Over-the-Counter (OTC) Drugs, Cosmetics, Nutritionals, and Non-Physical Devices
  22R2	Enable Narrative Templates for Report Types and Studies
  22R2	Enable 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
  22R3 New	Translation Connections and Localized Case Auto-Translation for Submissions
  22R2.0.2 New	Localized Record Deletion
  22R2.0.2 Updated	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
  22R3 New	MedDRA Synonym Field Exclusion and Candidate Auto-Creation
  22R3 New	IMDRF Dictionary for Maintenance, Case Processing, and Submissions
  22R3 New	MedDRA Bulk Recode Cases
  22R2	Support for Unconstrained UCUM for Test Result Units
  22R2	EDQM Mapping for Dose Form and Routes of Administration Terms
  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
  22R2 New	Cross Reporting Most Conservative Submission
  22R2 New	Partner Distribution Jurisdictions
  22R1	Automated Cross Reporting
  22R1	Support for MedDRA Queries in Submission Rules
  21R3	Enable PMDA (Japan) Submission Rules

• Submissions and Distributions

  Release Added or Changed	Feature
  22R3 New	Async Submit to Gateway
  22R2.0.2 New	Exclude Attachments and Literature Documents
  22R2 New	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
  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
  21R1	PADER Authoring and Table Generation

• Product Administration

  Release Added or Changed	Feature
  22R3 New	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
  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

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