Good Clinical Practice in Clinical trials - SHAIKH, SANIYA;Shetty, Vittaldas;Ambildhok, Kadambari
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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…mehr

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Produktbeschreibung
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.
Autorenporträt
Dr. Saniya Shakil Ahmed Shaikh is a Public Health Dentist with expertise in clinical trials, research ethics and public health. Her work bridges global Good Clinical Practice standards with the Indian regulatory framework. She believes that advancing healthcare begins with the union of sound science and strong ethics.