Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

• Intended Audience
• Documentation Accessibility
• About This Book
• The Oracle Health Sciences Safety Suite
• Conventions

1 Case Form

• 1.1 Reporter Information
• 1.2 Products Tab
• 1.3 Analysis Tab
  • 1.3.1 PMDA Information tab
    • 1.3.1.1 PMDA Information: General Tab
    • 1.3.1.2 PMDA Information: Comments Tab
  • 1.3.2 Product License Value
  • 1.3.3 PMDA Event Reportability Updates
  • 1.3.4 Case Form - PMDA Analysis tab
  • 1.3.5 PMDA E2B Report Mapping Updates
• 1.4 Activities Tab
• 1.5 Additional Information Tab
• 1.6 Regulatory Reports Tab
• 1.7 Conformance Rules Tab

2 Case Actions

• 2.1 PMDA Event Reportability

3 Worklist

• 3.1 Literature Intake Updates
  • 3.1.1 Import Tab Changes
  • 3.1.2 Processing Tab Changes
  • 3.1.3 Changes to Literature Duplicate Check
  • 3.1.4 Changes to Existing Screen Label

4 Reports

• 4.1 Reports: PMDA Expedited Reports
  • 4.1.1 Report Scheduling
  • 4.1.2 Paper Reports
  • 4.1.3 User Interface - Reporting Rules Configuration
  • 4.1.4 Expedited Reports on DLP
  • 4.1.5 Additional Expedited Report Updates
  • 4.1.6 PMDA Device Reports
• 4.2 Reports: PMDA Periodic Reports
  • 4.2.1 DLP at Report Level
  • 4.2.2 Periodic Reports on DLP
  • 4.2.3 Upgrade Considerations
  • 4.2.4 Advanced Conditions in J Periodic Reports
  • 4.2.5 Check in/Checkout Enhancements
  • 4.2.6 Other Changes
  • 4.2.7 Periodic Safety Report
    • 4.2.7.1 Format
    • 4.2.7.2 PSR /ReSD Details
  • 4.2.8 Clinical Study Periodic Safety Report (now J-DSUR)
    • 4.2.8.1 Format
    • 4.2.8.2 J-DSUR Details
    • 4.2.8.3 J-DSUR - Cover
    • 4.2.8.4 J-DSUR - Form 2
  • 4.2.9 Seiyakukyo Line Listing Report (Individual Report Common Line List)
    • 4.2.9.1 Configuration Screen
    • 4.2.9.2 Report Output Format
    • 4.2.9.3 Report Output Filter Criterion
    • 4.2.9.4 Report Output Field Mappings
    • 4.2.9.5 CSV Output Format
    • 4.2.9.6 Periodic Report Process Flow
• 4.3 Non-Reportable and Invalid Events

5 Utilities

• 5.1 MedDRA Browser