Table of Contents Table of Contents Title and Copyright Information Preface Documentation accessibility Related resources Access to Oracle Support 1 Business Configuration Configuring Product Family Configuring Key Ingredients Configuring Licenses License Configuration - Oracle Argus Safety Japan Specific Parameters Literature Intake Updates Configuring Studies Configuring Expedited Reporting Rules 2 System Configuration Configuring Common Profile Switches Common Profile Switches for Oracle Argus Safety Japan Common Profile Switches for Reporting Common Profile Switches for Device Report Common Profile Switches for E2B Profile Switch for Incomplete 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 3 Code List Configuration Code Lists General Functionality Changes Device Reporting Category Emperor J Reportable Product Keyword License Category Literature Type Reporting Category Literary Citation Reporting Destination Manufacturers Reporter Information Flexible Data Re-Categorization Reporting Category (LM_RPT_CATEGORY) License Category (LM_LIC_CATEGORY) Dev Phase (LM_DEV_PHASE) Risk Category of OTC Drug (LM_RISK_CATEGORY_OTC) Route for Acquiring OTC Drug (LM_ROUTE_ACQUIRE_OTC)