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Oracle® Argus Safety Administrator's Guide
Release 6.0.1
E15950-03
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Contents
Title and Copyright Information
Preface
Documentation Accessibility
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
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
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
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
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