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Oracle® Argus Safety Japanese Administrator's Guide
Release 8.0
E54655-01
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Contents
List of Figures
Title and Copyright Information
Preface
Intended Audience
Documentation Accessibility
About This Book
Conventions
1
Introduction
2
Business Configuration
Configuring Product Family
Configuring Licenses
PMDA Device Reporting Support in Console
Literature Intake Updates
Configuring Studies
Configuring Expedited Reporting Rules
3
System Configuration
Configuring Commmon Profile Switches
Common Profile Switches
Profile Switch for Incompletion Report Submission - Auto Action item
Configuring Field Level Validations
Field Label Configuration (J Specific)
PMDA Downgrade/nullification Report Scenario when All Events are Non-Reportable
Configuring Field Labels
User Defined Fields Updates
Configuring Local Reports - Local Reporting Rule and Local Reports
4
Code List Configuration
Code Lists
General Functionality Changes
Device Reporting Category
Emperor
J Reportable Product Keyword
License Category
Literature Type
Reporting Category
Literary Citation
Manufacturers
Reporter Information