Table of Contents
- Title and Copyright Information
- Preface
- 1 Revision History
- 2 Introduction
- 3 Reporting Destinations setup
- 4 Reporting Rules setup
- 5 Set up an E2B(R3) profile for ICSR and ACK
- 6 MFDS codes for Products and Ingredients in Post-marketed Domestic Cases
- 7 WHO codes for Products and Ingredients in Post-marketed Foreign Cases
- 8 Clinical Trial Approval Number (C.5.1.r.1) and Clinical Trial Serial Number (C.5.3) for Study cases
- 9 About the study name (C.5.2) for the Study cases
- 10 Other Health Professional Type (C.2.r.4.KR.1) for cases reported by Other Health Professional
- 11 Health Professional Type (C.3.1.KR.1) for cases with Health Professional Sender Type
- 12 Study Type (C.5.4.KR.1) for studies other than Clinical Trial or Compassionate Use studies
- 13 Regional Causality Assessment (G.k.9.i) for post-marketed Domestic cases and Study cases
- 14 Reporting to MFDS for legacy cases