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Contents
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
1
Introduction
2
Business Configuration
2.1
Configuring Product Family
2.2
Configuring Licenses
2.2.1
License Configuration - Argus J Specific Parameters
2.2.2
Literature Intake Updates
2.3
Configuring Studies
2.4
Configuring Expedited Reporting Rules
3
System Configuration
3.1
Configuring Common Profile Switches
3.1.1
Common Profile Switches
3.1.1.1
Profile Switch for Incomplete Report Submission - Auto Action item
3.2
Configuring Field Level Validations
3.2.1
Field Label Configuration (J Specific)
3.2.1.1
PMDA Downgrade/nullification Report Scenario when All Events are Non-Reportable
3.3
Configuring Field Labels
3.3.1
User Defined Fields Updates
3.4
Configuring Local Reports - Local Reporting Rule and Local Reports
4
Code List Configuration
4.1
Code Lists
4.1.1
General Functionality Changes
4.1.2
Device Reporting Category
4.1.3
Emperor
4.1.4
J Reportable Product Keyword
4.1.5
License Category
4.1.6
Literature Type
4.1.7
Reporting Category
4.1.8
Literary Citation
4.1.9
Reporting Destination
4.1.10
Manufacturers
4.1.11
Reporter Information
4.1.12
Flexible Data Re-Categorization
4.1.12.1
Reporting Category (LM_RPT_CATEGORY)
4.1.12.2
License Category (LM_LIC_CATEGORY)
4.1.12.3
Dev Phase (LM_DEV_PHASE)
4.1.12.4
Risk Category of OTC Drug (LM_RISK_CATEGORY_OTC)
4.1.12.5
Route for Acquiring OTC Drug (LM_ROUTE_ACQUIRE_OTC)
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