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1/6
Contents
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
1
Business Configuration
1.1
Configuring Product Family
1.2
Configuring Key Ingredients
1.3
Configuring Licenses
1.3.1
License Configuration - Argus J Specific Parameters
1.3.2
Literature Intake Updates
1.4
Configuring Studies
1.5
Configuring Expedited Reporting Rules
2
System Configuration
2.1
Configuring Common Profile Switches
2.1.1
Common Profile Switches for Argus J
2.1.2
Common Profile Switches for Reporting
2.1.3
Common Profile Switches for Device Report
2.1.4
Common Profile Switches for E2B
2.1.5
Profile Switch for Incomplete Report Submission - Auto Action item
2.2
Configuring Field Level Validations
2.2.1
Field Label Configuration (J Specific)
2.2.1.1
PMDA Downgrade/nullification Report Scenario when All Events are Non-Reportable
2.3
Configuring Field Labels
2.3.1
User Defined Fields Updates
2.4
Configuring Local Reports - Local Reporting Rule and Local Reports
3
Code List Configuration
3.1
Code Lists
3.1.1
General Functionality Changes
3.1.2
Device Reporting Category
3.1.3
Emperor
3.1.4
J Reportable Product Keyword
3.1.5
License Category
3.1.6
Literature Type
3.1.7
Reporting Category
3.1.8
Literary Citation
3.1.9
Reporting Destination
3.1.10
Manufacturers
3.1.11
Reporter Information
3.1.12
Flexible Data Re-Categorization
3.1.12.1
Reporting Category (LM_RPT_CATEGORY)
3.1.12.2
License Category (LM_LIC_CATEGORY)
3.1.12.3
Dev Phase (LM_DEV_PHASE)
3.1.12.4
Risk Category of OTC Drug (LM_RISK_CATEGORY_OTC)
3.1.12.5
Route for Acquiring OTC Drug (LM_ROUTE_ACQUIRE_OTC)
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