Navigating Clinical Trials: Essential Knowledge for Dermatologists-Good Clinical Protocol (GCP) and Research Ethics

Good Clinical Protocol (GCP) and Research Ethics

Video Transcription

Video Summary

In a seminar on Good Clinical Protocol (GCP) and research ethics, dermatologist Chi-Ho Hong provides an overview of GCP, emphasizing its foundation in the Declaration of Helsinki. GCP ensures the credibility of clinical trial data while protecting trial subjects' rights and safety. Hong highlights key GCP principles, including ethical conduct, risk-benefit analysis, informed consent, data confidentiality, and quality assurance. He underscores the importance of the International Council for Harmonization (ICH) guidelines for standardized clinical trial processes across the EU, Japan, and the U.S. Compliance with these guidelines is crucial for data integrity and patient protection during research audits.

Asset Subtitle

by Chin-Ho Hong, MD

Keywords

Good Clinical Protocol

Declaration of Helsinki

International Council for Harmonization

informed consent

data integrity