1/2

Contents

Quickstart Guide

• Logging in
• Entering Case Data
  • Creating a New Case
  • Finding an Existing Case
  • Updating a Case
    • Entering General Data
    • Entering Patient Data
      • Patient Tab
      • Parent Tab
    • Entering Products Data
      • Drug Tab
      • Device Tab
      • Vaccine Tab
    • Entering Events Data
      • Event Tab
      • Event Assessment Tab
  • Viewing Updates made to your Case
  • Attaching Additional Information to your Case
• Reviewing your Cases
  • Viewing New Cases in the Worklist
  • Finding a Case Assigned to you
  • Viewing your Pending Action Items
  • Viewing your Worklist Action Items
  • Viewing your Coding Action Items
  • Performing a Medical Review
    • Reviewing Case Narrative
    • Reviewing MedWatch Information
    • Reviewing BfArM Information
    • Reviewing AFSSaPS Information
• Managing your Report Submissions
  • Scheduling an Expedited Report
  • Reviewing a Draft Report
  • Generating an Expedited Report
  • Transmitting a Report
  • Tracking your ICSR Report Submissions
    • Reports Tab
    • Messages Tab
  • Finding an Overdue Report
• Documentation Accessibility