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Contents

Title and Copyright Information

Preface

• Audience
• The Oracle Health Sciences Safety Suite
• Documentation Accessibility
• Related Documents
• Checking My Oracle Support
• Conventions

1 About Argus Interchange

• Argus Interchange Process Overview
• ICSR
  • Minimum Requirement for Electronic Report Generation

2 Configuring Argus Interchange

• ESM Mapping Utility
  • Configuring Argus Interchange Service
    • Service INI File Setup Dialogue Box
  • Adding a Database for Argus Interchange Service
    • Service DB Setup Fields
• Argus Console
  • Configuring Regulatory Authorities
  • Configuring Code List Items

3 Configuring Argus Interchange - Web

• Web-based Interchange Mapping
  • Navigating to Interchange Mapping
  • Managing Profiles
    • Defining a Profile
      • Using the Transmit Tab
      • Using the Conformance Rules Tab
      • Using the Receive Tab
    • Printing a Profile
    • Copying a Profile
    • Deleting a Profile
  • Comparing Profiles
    • Comparing Profile Dialog Box Fields
  • ICSR Codes Translation
    • ICSR Codes Translation Fields
    • Configuring ICSR Codes Translation
  • Viewing the Audit Log
    • Audit Log Dialog Box Fields
  • E2B Extensions

4 Validating ICSR Reports

• Why perform an ICSR check?
• Report Generation Validations
• Validation Rules

5 Transmitting and Monitoring Reports

• Logging In and Out of Argus Safety
  • To Log Out of the Argus Application
• Scheduling Reports
  • New Expedited Report Dialogue Fields
  • Nullification Reports
  • Follow-Up eMDR Reports
  • Follow-up eVAERS Reports
• Generating Reports
  • Attachments in Reports
• Transmitting Reports
  • Transmitting ICSR Reports
  • Transmitting Bulk Reports by Form
  • Monitoring ICSR Transmit Status
    • ICSR Transmit Status Fields
    • Message Acknowledgement Status Dialogue Fields
  • Monitoring ICSR Receive Status
    • ICSR Receive Status Dialogue Fields
    • Message Acknowledgement Status Dialogue Fields
    • Validation Check of Incoming Message
  • Viewing Status
  • Viewing Acknowledgement Information

6 Using the ICSR Viewer

• Opening the ICSR Viewer
• Exporting an XML File

7 Importing E2B Reports

• Incoming E2B Reports
  • Conversion of E2B (R3) reports to E2B (R2) format (applicable only for E2B (R3) reports)
  • Searching for Duplicate Cases
    • Duplicate Search Dialogue Box Fields
  • Using the View Differences Report
    • Displaying Differences
  • Viewing the E2B Report
  • Accepting Single/Multiple E2B Reports
  • E2B Initial/Follow-up Intake
  • E2B Follow-up Acceptance for Closed/Locked Cases
• Processed ICSR Reports