Contents

List of Figures

Title and Copyright Information

Preface

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

1 Introduction

2 Business Configuration

• Configuring Product Family
• Configuring Licenses
  • License Configuration - Argus J Specific Parameters
  • Literature Intake Updates
• Configuring Studies
• Configuring Expedited Reporting Rules

3 System Configuration

• Configuring Common Profile Switches
  • Common Profile Switches
    • Profile Switch for Incomplete Report Submission - Auto Action item
• Configuring Field Level Validations
  • Field Label Configuration (J Specific)
    • PMDA Downgrade/nullification Report Scenario when All Events are Non-Reportable
• Configuring Field Labels
  • User Defined Fields Updates
• Configuring Local Reports - Local Reporting Rule and Local Reports

4 Code List Configuration

• Code Lists
  • General Functionality Changes
  • Device Reporting Category
  • Emperor
  • J Reportable Product Keyword
  • License Category
  • Literature Type
  • Reporting Category
  • Literary Citation
  • Reporting Destination
  • Manufacturers
  • Reporter Information
  • Flexible Data Re-Categorization
    • Reporting Category (LM_RPT_CATEGORY)
    • License Category (LM_LIC_CATEGORY)
    • Dev Phase (LM_DEV_PHASE)
    • Risk Category of OTC Drug (LM_RISK_CATEGORY_OTC)
    • Route for Acquiring OTC Drug (LM_ROUTE_ACQUIRE_OTC)