Contents

Title and Copyright Information

Preface

• Intended Audience
• 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 Access Management

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

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
  • Configuring Products
    • Field Descriptions
    • 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
    • Adding Product 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
    • Configuring Case Form (System Management)
    • SMTP Configuration
    • Configuring Case Processing
    • Configuring Assessments
    • Configuring Auto Archiving
    • Configuring Case Numbering
    • Configuring Lot Number
    • Configuring MedDRA Browser
    • Configuring WHO Drug
    • Configuring Performance
    • Configuring Documentum
    • Configuring E2B
    • Local Labeling
    • User Interface
  • Reporting Configuration
    • Configuring Reporting
    • Configuring Security
    • Configuring Single Sign-on
    • Error Messages
    • Configuring SMTP
    • Configuring Workflow Items
  • Configuring Workflow
    • Worklist Updates
    • Configuring Case Workflow
    • Worklist Intake
  • Configuring System Numbering
    • Field Descriptions
  • Configuring Field Labels
    • Field Descriptions
  • Adding User Defined Fields
  • Configuring User Defined Fields

5 Code List Configuration

• Configuring Code Lists > Argus
  • Configuring Autosignals
    • Field Descriptions
  • Configuring Batch Reports
    • Field Descriptions
  • Configuring Letters
    • Field Descriptions
  • Configuring Justifications
    • Field Descriptions
  • Configuring Electronic Transmission
    • Field Descriptions
  • Configuring Event Groups
    • Terms tab
    • Event Groups tab
    • SMQ tab
  • Configuring Literary Citations
    • Field Descriptions
  • Configuring Message Type
    • Field Descriptions
  • Configuring Reporting Destination
    • Agency Information
    • Local Company Contact
    • Configuring EDI
    • SMTP
  • Configuring Routes of Administration
    • Field Descriptions
  • Configuring Study Center
    • Field Descriptions
  • Configuring Holiday Calendar
    • Field Descriptions
  • Other Code List Items
    • Formulation Factory Data
• Configuring Code Lists > Flexible Data Re-Categorization
  • Flexible Code Lists
  • Flexible Re-Categorization

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

8 Best Practices

• Overall switching the system to eVAERS
  • Configuring Reporting Destination for eVAERS Profile
  • Configuring Business Logic For Data Elements Without Default Logic Using UDF Fields
  • Configuring Reporting Rules
  • Configuring Codelists
    • Relation to Patient
    • Anatomical Location
    • Ethnicity
    • Vaccination Funds
    • Vaccination Facility
  • Setting up the Application Type in Business Configuration > Products and Licenses
  • Optional upgrade scripts for data migration to new fields
    • Illness at the time of Vaccination
    • Emergency Room Visit
    • Prior Adverse Event
  • Validation of Case Prior to Generation of eVAERS
• Configuring E2B (R3) Reports
  • Configuring Reporting Destination for E2B (R3) Profile
  • Configuring Common Profile Switches for E2B (R3) Reports
  • Configuring Common Profile Switches for E2B (R3) Reports
• Attachments in E2B (R3) and eVAERS Reports
• Creating and Managing Amendments for eVAERS and E2B (R3) Reports
• Best Practices in a Multi-Tenant Environment
  • Single Sign-on
    • Accessing Argus Safety Directly via URL
  • Global Homepage and Portlets
    • Global Worklists Columns
    • Global User Management
    • User-Enterprise Association
    • New User Creation/Association
    • Inactivating an Enterprise
  • New Enterprise Setup
  • Segregated by Enterprise
    • Maintaining Consistency Across Enterprises
  • Shared Across Enterprises
  • Pre-upgrade Considerations for Existing Databases
  • Post-upgrade Considerations for Existing Databases
  • Documentum Migration