Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

• Intended Audience
• Documentation Accessibility
• About This Book
• Conventions

1 Case Form

• Reporter Information
• Products Tab
• Analysis Tab
  • PMDA Information tab
    • PMDA Information: General Tab
    • PMDA Information: Comments Tab
  • Product License Value
  • PMDA Event Reportability Updates
  • Case Form - PMDA Analysis tab
  • PMDA E2B Report Mapping Updates
• Activities Tab
• Additional Information Tab
• Regulatory Reports Tab

2 Case Actions

• PMDA Event Reportability

3 Worklist

• Literature Intake Updates
  • Import Tab Changes
  • Processing Tab Changes
  • Changes to Literature Duplicate Check
  • Changes to Existing Screen Label

4 Reports

• Reports: PMDA Expedited Reports
  • Paper Reports
  • User Interface - Reporting Rules Configuration
  • Expedited Reports on DLP
  • Additional Expedited Report Updates
  • PMDA Device Reports
• Reports: PMDA Periodic Reports
  • DLP at Report Level
  • Periodic Reports on DLP
  • Upgrade Considerations
  • Advanced Conditions in J Periodic Reports
  • Check in/Checkout Enhancements
  • Other Changes
  • Periodic Safety Report
    • Format
    • PSR /ReSD Details
  • Clinical Study Periodic Safety Report (now J-DSUR)
    • Format
    • J-DSUR Details
    • J-DSUR - Cover
    • J-DSUR - Form 2
  • Seiyakukyo Line Listing Report (Individual Report Common Line List)
    • Configuration Screen
    • Report Output Format
    • Report Output Filter Criterion
    • Report Output Field Mappings
    • CSV Output Format
    • Periodic Report Process Flow
• Non-Reportable and Invalid Events

5 Utilities

• MedDRA Browser