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A modern application for the collection, management, and real-time oversight of adverse events.

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Case Intake
Process a Case
Generate Individual Case Safety Reports
Reporting Rules
- Understand the Reporting Rules Engine
- One Last Time Reporting
- Reporting Rule Sets
- Reporting Rule Parameter Reference
- Cross Reporting
- Configure Reporting Rules Product Selection
- Manage Reporting Rule Versions
- Configure Back Reporting
- Agency Submission Rules
- Standard Agency ICSR Submissions
- Assign a Rule Set to an Agency
- Distribution Rules
- Manage Partner Distribution Lists
- Manage MAH Distribution Lists
Send Safety Reports
Manage Documents
Prepare Aggregate Reports
- Aggregate Reports Overview
- Create Reports
- Create a DSUR
- Create a PADER
- Create a PBRER
- Create a PSUR
- Create a CIOMS II
- Generate Tabulations
- How Aggregate Reports Filter by Data Period
- Generate Aggregate Report Tabulations
- Generate Masked Aggregate Tabulations (CIOMS II, PBRER and DSUR)
- Author Report Documents
- Prepare Aggregate Report Documents
- Coordinate Aggregate Report Submission
Use Reports and Dashboards
Vault to Vault Connections
- About the Safety-RIM Vault Connection
Configure the Environment
- Administration Overview
- Business Administration
- Application Licensing for Active Case Versions
- Manage Organizations
- Administer Products
  - Manage Products
  - Manage Combination Products
- Manage Studies
- Set Up the Localized Business Admin Library
- See Action Items Across Case Versions
- Customize the Inbox Item Page Layout
- Configure the Inbox Item Follow-Up Case Compare Layout
- Configure Case Promotion Settings
- Configure Email to Vault Safety Inbox Item
- Configure Adverse Event Watchlists
- Manage Datasheets and Auto-Expectedness
- Set Up Scheduled Follow-Up Questionnaire Emails
- Manage Safety Inbox Loader Multi-Case CSV Data Import
- Migrate External Cases
- Configure Company Product Match Verification
- Configure Narrative Templates
- Configure Controlled Vocabularies
- Configure Reasons Omitted
- Bulk Unblind a Study
- Configure Blind Protection Relatedness Override
- User Administration
- Manage Users & Groups
- Manage Case Access Group Security
- Coding Dictionaries
- Manage the MedDRA Dictionary
- Manage MedDRA Synonyms
- Bulk Recode MedDRA-Coded Terms on Cases
- Use MedDRA Queries
- Manage the WHODrug Dictionary
- Manage the Japan Drug Dictionary
- Manage the IMDRF Dictionary
- Manage EDQM Mapping for Dose Form and Routes of Administration Terms
- Individual Case Safety Report Configuration
- Configure Custom Validation Criteria
- Transmission Profiles & Gateways
- Manage Transmission Profiles
- Configure Email Transmissions
- Configure AS2 Connections
  - FDA AS2 Connection
  - EMA AS2 Connection
  - Health Canada AS2 Connection
  - MHRA AS2 Connection
  - PMDA AS2 Connection
  - NMPA AS2 Connection
  - RZN AS2 Connection
  - Custom AS2 Connections
  - Replace a Gateway Profile with an AS2 Connection
- Configure Gateways
  - FDA Gateway
  - EMA Gateway
  - Health Canada Gateway
  - MHRA Gateway
  - PMDA Gateway
  - Custom Gateways
- Configure Your Vault for the Receive E2B API
- Aggregate Report Configuration
- Configure Aggregate Reporting Families
- Configure Aggregate Report Templates
- System Administration
- Manage Field Encryption
- Configure Object Naming Conventions
- Define User Actions for Document States
- Configuring the Safety-RIM Vault Connection