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Contents

Title and Copyright Information

Preface

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

1 About Argus Interchange

• 1.1 Argus Interchange Process Overview

2 Configure Argus Interchange

• 2.1 Argus Interchange Mapping Utility
  • 2.1.1 Configure the Argus Interchange Service
    • 2.1.1.1 Service INI File Setup Dialog Box
  • 2.1.2 Add a Database for Argus Interchange Service
    • 2.1.2.1 Service DB Setup Fields
• 2.2 E2B Extensions (Applicable for R2 only)
• 2.3 Web Console
  • 2.3.1 Configure Regulatory Authorities
    • 2.3.1.1 EDI Tab Fields
  • 2.3.2 Configure SMTP
    • 2.3.2.1 SMTP Configuration Dialog Box Fields
  • 2.3.3 Configure Code List Items
    • 2.3.3.1 Configure an Action Taken
    • 2.3.3.2 Configure Age Groups
    • 2.3.3.3 Configure Age Units
    • 2.3.3.4 Configure Attachment Classifications
    • 2.3.3.5 Configure Dosage Units
    • 2.3.3.6 Configure an Event Outcome
    • 2.3.3.7 Configure Gender
    • 2.3.3.8 Configure Report Type
    • 2.3.3.9 Configure Reporter Type
    • 2.3.3.10 Configure Routes of Administration
    • 2.3.3.11 Configure a Message Type
    • 2.3.3.12 ICSR Length Check
    • 2.3.3.13 E2B Code Validation

3 ICSR Check

• 3.1 Why perform an ICSR Check
  • 3.1.1 ICSR Validation

4 Transmit and Monitor ICSR Reports

• 4.1 Log In and Out of Argus Safety
  • 4.1.1 To Log Out of the Argus Application
• 4.2 Schedule an E2B Report
  • 4.2.1 New Expedited Report Dialog Fields
• 4.3 View a Scheduled E2B Report
• 4.4 Transmit E2B Reports
  • 4.4.1 Transmit Bulk Reports by Form
  • 4.4.2 Monitor ICSR Transmit Statuses
    • 4.4.2.1 ICSR Transmit Status Fields
    • 4.4.2.2 Message Acknowledgement Status Dialog Fields
    • 4.4.2.3 PMDA ACK Import Logic
  • 4.4.3 Monitor ICSR Receive Statuses
    • 4.4.3.1 ICSR Receive Status Dialog Fields
    • 4.4.3.2 Message Acknowledgement Status Dialog Fields
    • 4.4.3.3 Validation Check of Incoming Message
  • 4.4.4 Nullification Reports
  • 4.4.5 View Statuses
  • 4.4.6 View Acknowledgement Information

5 Use the ICSR Viewer

• 5.1 Open the ICSR Viewer
  • 5.1.1 PMDA E2B Report Mapping
• 5.2 Export an SGML File

6 Import ICSR Reports

• 6.1 Incoming ICSR Reports
  • 6.1.1 Search for Duplicate Cases
    • 6.1.1.1 Duplicate Search Dialog Box Fields
  • 6.1.2 Use the View Differences Report
    • 6.1.2.1 Displaying Differences
  • 6.1.3 View the E2B Report
  • 6.1.4 Accept Single/Multiple E2B Reports
  • 6.1.5 E2B Initial/Follow-up Intake
  • 6.1.6 E2B Follow-up Acceptance for Closed/Locked Cases
  • 6.1.7 Source XML Received for the Case
  • 6.1.8 Import E2B (R3) Messages
  • 6.1.9 ICSR Pending Screen for (R3) Report
  • 6.1.10 PMDA E2B R3 ACK
• 6.2 Processed ICSR Reports
  • 6.2.1 Total Number of Rows Fields

Glossary