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Good Clinical Practice in Clinical trials

By Saniya Shaikh

Good Clinical Practice in Clinical trials

By Saniya Shaikh

- Default Title
Description
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.
Product details
Binding:
Paperback
Number of Pages:
220
Release Date:
2025-08-13
Publication Date:
2025-08-13
Publisher:
LAP LAMBERT Academic Publishing
Languages:
Original: English
ISBN10:
6208455987
ISBN13:
9786208455989
GPSR Manufacturer Reference:
[email protected]
Weight:
346 g
Height:
150 cm
Width:
220 cm
Thickness:
14 cm
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