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Application

Role

Category

Get Started
Case Intake
- Inbox Item Transition From AERs
- Case Intake Overview
- Receive an E2B Transmission
- E2B Case Import Data Mapping
- Inbox Item Intake
- Manual Inbox Item Intake
- Import an Inbox Item from an E2B File
- Perform Local Language to English Intake
- Inbox Item Field Reference
- AER Intake
- Create an AER
- AER Field Reference
- Reject an AER
- Request Additional Information
- Case Promotion
- Promote to Case
- Promote to Multiple Cases
- Copy Patient Information from Existing Case
- Automated Case Promotion
- Merge to In-Flight Case
- Inbox Item Follow-Up
Process a Case
Generate Individual Case Safety Reports
Reporting Rules
- Understand the Reporting Rules Engine
- 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
Configure the Environment
- Administration Overview
- Business Administration
- Manage Organizations
- Administer Products
  - Manage Products
  - Manage Combination Products
- Manage Studies
- Bulk Unblind a Study
- Manage Datasheets and Auto-Expectedness
- Set Up the Localized Business Admin Library
- Migrate External Cases
- Configure Narrative Templates
- Configure the Inbox Item Follow-Up Case Compare Layout
- Configure the Case Promotion Settings Page
- See Action Items Across Case Versions
- Configure Adverse Event Watchlists
- Set Up Scheduled Follow-Up Questionnaire Emails
- Configure Controlled Vocabularies
- Configure Reasons Omitted
- Configure Email to Vault Safety Inbox Item
- Configure Blind Protection Relatedness Override
- User Administration
- Manage Users
- Manage License Types
- Manage Security Profiles
- Manage Application Roles
- Configure User Access to Inbox Items
- 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 IMDRF Dictionary
- Transmission Profiles & Gateways
- Manage Transmission Profiles
- Configure Email Transmissions
- 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

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