Contents

Title and Copyright Information

Preface

• Documentation Accessibility
• About This Book
• Conventions

1 Introduction

• Introduction
  • Argus Safety Configuration Process Overview
  • Usage Conventions
  • Getting Started
  • Argus Console Architecture
    • Required Fields
    • Standard Buttons
    • Standard Icons
  • Administrator Login
    • Logging In as an Administrator:
    • Changing the Administrator's Password
    • Logging out
    • Accessing the Home Page
    • Launching Online Help
    • Understanding Argus Console GUI

2 User Configuration

• User Configuration
  • Configuring User Sites
    • Field Descriptions
  • Configuring User Groups
    • Field Descriptions
    • Adding User Sites
    • Adding User Groups
    • Printing a User Group
  • Configuring Users
    • Field Descriptions
    • Adding Users
    • Printing a User Group

3 Business Configuration

• About Business Configuration
  • Editable and Non-editable Business Configuration Sections
    • Type Ahead Fields
    • Additional Comments Fields
  • Configuring Product Family
    • Field Descriptions
    • Adding Product Families
    • Creating Data Sheets
    • Field Descriptions
    • Adding a New Data Sheet
  • Configuring Products
    • Field Descriptions
    • Adding Products
    • Adding Products
  • Configuring Licenses
    • Field Descriptions
    • Adding Product Licenses
    • Using the Product Browser
  • Configuring Clinical Studies
    • Field Descriptions
    • Adding Clinical Study Configurations
    • Adding WHO Drug Details
    • Configuring Auto Encoding
    • Configuring Study Reporting
  • Configuring Expedited Report Rules
    • Field Descriptions
    • Adding Expedited Report Rules

4 System Configuration

• System Configuration Overview
  • Configuring Case Priority
    • Field Descriptions
  • Configuring Field Validations
    • Field Descriptions
    • Modifying Field Validations
  • Configuring LAM System Numbering
    • Field Descriptions
  • Configuring System Management - Common Profile Switches
    • Configuring Advanced Conditions
    • Field Descriptions
  • Configuring Argus J
    • Configuring Argus J E2B Profile Switches
    • Configuring Argus J Reporting Profile Switches
  • Configuring Case Form (System Management)
    • Auto Encoding / Central Encoding
    • Automation
    • Templates
    • Modify Data Lock Point
  • Configuring Custom HTTP Header
  • Configuring Case Processing
    • Field Descriptions
  • Configuring Assessments
    • Field Descriptions
  • Configuring Auto Archiving
    • Field Descriptions
  • Configuring Case Numbering
    • Field Descriptions
  • Configuring Lot Number
    • The Custom Node
  • Configuring MedDRA Browser
    • Field Descriptions
  • Configuring WHO Drug
  • Configuring Performance
    • Field Descriptions
  • Configuring Documentum
    • Field Descriptions
  • Configuring E2B
    • Field Descriptions
  • Local Labeling
    • Configuring Local Labeling
    • Field Descriptions
    • Configuring LAM
    • Configuring MedWatch
  • Reporting Configuration
    • Configuring Reporting
    • Field Descriptions
    • Expedited Reports Configuration
    • Configuring Security
    • Configuring Single Sign-on
    • Error Messages
    • Configuring SMTP
    • Field Descriptions
    • Configuring Workflow Items
    • Field Descriptions
  • Configuring Workflow
    • Worklist Updates
    • Configuring Case Workflow
    • Worklist Intake
  • Configuring System Numbering
    • Field Descriptions
  • Configuring Field Labels
    • Field Descriptions
    • Configuring User Defined Fields

5 Code List Configuration

• Configuring Code Lists
  • General Requirements for Code Lists
  • Configuring Autosignals
    • Field Descriptions
  • Configuring Batch Reports
    • Field Descriptions
  • Configuring Letters
    • Field Descriptions
  • Configuring Justifications
    • Field Descriptions
  • Configuring Electronic Transmission
    • Field Descriptions
  • Configuring Literary Citations
    • Field Descriptions
  • Configuring Message Type
    • Field Descriptions
  • Configuring Reporting Destination
    • Initial/Follow-up Source XML
    • Initial Selection PDF
    • Follow-up Source XML
    • Agency Information
    • Local Company Contact
    • Configuring EDI
    • SMTP
  • Configuring Routes of Administration
    • Field Descriptions
  • Configuring Study Center
    • Field Descriptions
  • Other Code List Items
    • Formulation Factory Data
    • Literary Citations Code List Item
    • Additional Information about the Manufacturer Code List Item
    • Additional Information about the Reporter Information Code List Item
    • Additional Information about the Reporting Destination Code List Item
    • Study Development Phase Code List Element
    • Event Occurred as Consequence of Code List Element
    • Emperor Code List Element
    • License Category Code List Element
    • Reporting Category Code List Element
    • Literature Type Code List Item

6 Accessing Tools

• Accessing Tools
  • Report Features
  • Viewing the E2B Length Check Report

7 Using Advanced Conditions

• Using Advanced Conditions
  • Features within Advanced Conditions
  • Using Advanced Conditions
  • Creating Advanced Conditions
  • Creating a Query Set of Advanced Conditions
    • New Action Type Fields and Field Description
  • The Hit List Tab