Contents

Title and Copyright Information

Preface

• Intended Audience
• The Oracle Health Sciences Safety Suite
• Documentation Accessibility
• Related Documents
• 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 Dictionary Browser
    • Configuring WHO Drug
    • Configuring Performance
    • Configuring Documentum
    • Local Labeling
    • User Interface
    • 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 Properties
    • 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
    • Configuring the Base Directory Path
    • 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

• Configuring Argus Safety for ICSR Reports (HL7)
  • Configuring Reporting Destination for HL7 ICSR Reports
  • Customizing Profiles
  • Configuring ICSR Validation using the New Framework
  • Configuring Codelists
    • eMDR Specific Codelist Updates
    • eVAERS Specific Codelist Updates
  • PMDA E2B (R3) Flex Codelist
  • Business Configuration Updates
    • Setting up the Application Type in Business Configuration -> Products and Licenses (eVAERS specific)
    • Configuring PMDA Specific License Parameters
    • Configuring PMDA E2B (R3) Specific Study Parameter
  • System Configuration Updates
    • PMDA E2B (R3) Specific Switches
  • Optional Upgrade Scripts for Data Migration to New Fields
    • eVAERS specific
    • eMDR Specific
  • Importing E2B (R3) Reports
• Attachments in HL7 Reports
• Creating and Managing Amendments for eVAERS and E2B (R3) report
• Null Flavor Handling in HL7 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