Good Clinical Practice in Clinical trials

ISBN-13: 9786208455989 / Angielski / Miękka / 2025 / 220 str.

SANIYA SHAIKH; Vittaldas Shetty; Kadambari Ambildhok

Opis

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 assurance, and regulatory compliance. With a focus on both global standards and the Indian context, the book bridges theory and practical application, serving as a valuable resource for researchers, clinicians, ethics committee members, and students involved in biomedical and health research.