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Contents

Title and Copyright Information

Preface

• Where to Find More Information
• Documentation Accessibility
• Revision History

1 Business Configuration

• 1.1 Configuring Product Family
• 1.2 Configuring Key Ingredients
• 1.3 Configuring Licenses
  • 1.3.1 License Configuration - Argus J Specific Parameters
  • 1.3.2 Literature Intake Updates
• 1.4 Configuring Studies
• 1.5 Configuring Expedited Reporting Rules

2 System Configuration

• 2.1 Configuring Common Profile Switches
  • 2.1.1 Common Profile Switches for Argus J
  • 2.1.2 Common Profile Switches for Reporting
  • 2.1.3 Common Profile Switches for Device Report
  • 2.1.4 Common Profile Switches for E2B
  • 2.1.5 Profile Switch for Incomplete Report Submission - Auto Action item
• 2.2 Configuring Field Level Validations
  • 2.2.1 Field Label Configuration (J Specific)
    • 2.2.1.1 PMDA Downgrade/nullification Report Scenario when All Events are Non-Reportable
• 2.3 Configuring Field Labels
  • 2.3.1 User Defined Fields Updates
• 2.4 Configuring Local Reports - Local Reporting Rule and Local Reports

3 Code List Configuration

• 3.1 Code Lists
  • 3.1.1 General Functionality Changes
  • 3.1.2 Device Reporting Category
  • 3.1.3 Emperor
  • 3.1.4 J Reportable Product Keyword
  • 3.1.5 License Category
  • 3.1.6 Literature Type
  • 3.1.7 Reporting Category
  • 3.1.8 Literary Citation
  • 3.1.9 Reporting Destination
  • 3.1.10 Manufacturers
  • 3.1.11 Reporter Information
  • 3.1.12 Flexible Data Re-Categorization
    • 3.1.12.1 Reporting Category (LM_RPT_CATEGORY)
    • 3.1.12.2 License Category (LM_LIC_CATEGORY)
    • 3.1.12.3 Dev Phase (LM_DEV_PHASE)
    • 3.1.12.4 Risk Category of OTC Drug (LM_RISK_CATEGORY_OTC)
    • 3.1.12.5 Route for Acquiring OTC Drug (LM_ROUTE_ACQUIRE_OTC)