Table of Contents
- Title and Copyright Information
- Preface
- 1 Introduction
- 2 Setting up Reporting Destinations
- 3 Setting up Reporting Rules
- 4 Set up an E2B(R3) profile for ICSR and ACK
- 5 MFDS codes for Products and Ingredients in Post-marketed Domestic Cases
- 6 WHO codes for Products and Ingredients in Post-marketed Foreign Cases
- 7 Clinical Trial Approval Number and Clinical Trial Serial Number for Study cases
- 8 Other Health Professional Type (C.2.r.4.KR.1) for cases reported by Other Health Professional
- 9 Health Professional Type (C.3.1.KR.1) for cases with Sender Type Health Professional
- 10 Study Type (C.5.4.KR.1) for studies other than CT or CU studies
- 11 Regional Causality Assessment for post-marketed Domestic cases and Study cases
- 12 Reporting to MFDS for legacy cases