Introduction to GCP and ICH E6(R3)
4 lessons · 180 min
1.1 What is Good Clinical Practice?
Understand GCP as the international ethical, scientific, and quality standard that protects research participants while ensuring reliable clinical trial data.
1.2 Historical and Ethical Foundations of GCP
Trace the evolution of research ethics from the Nuremberg Code through the Declaration of Helsinki and Belmont Report to understand why GCP protections exist.
1.3 The Global Regulatory Landscape
Navigate the international framework of clinical trial regulation, from ICH harmonization to regional requirements across FDA, EMA, PMDA, and NMPA jurisdictions.
1.4 Structure and Scope of ICH E6(R3)
Master the organization of ICH E6(R3) to locate guidance efficiently: the Principles section, Annex 1 operational requirements, Appendices, and Glossary.