This book provides a comprehensive guide to Good Clinical Practice (GCP), the internationally recognized ethical and scientific standard for designing, conducting, monitoring, and reporting clinical trials. It explores the history and evolution of GCP, the key guidelines from global and national regulatory bodies, and the ethical principles that protect the rights, safety, and well-being of research participants. The text explains the roles and responsibilities of sponsors, investigators, and ethics committees, and outlines the processes involved in trial design, informed consent, quality...
This book provides a comprehensive guide to Good Clinical Practice (GCP), the internationally recognized ethical and scientific standard for designing...