Table of Contents Table of Contents Title and Copyright Information Preface Documentation accessibility Diversity and Inclusion Related resources Access to Oracle Support 1 Revision history 2 Introduction 3 Set up reporting destinations to send E2B(R3) report Configure the EDI and Report tabs for EMA and PMDA Configure the EDI and Report tab for FDA Additional Information Configure Studies for FDA IND or Pre-ANDA reporting Configure expedited rules 4 Configure parameters for E2B(R3) reports 5 Customize E2B(R3) profiles