Items related to Good Clinical Practice in Clinical trials: Ethical...

Good Clinical Practice in Clinical trials: Ethical and Scientific Standards for Designing, Conducting, and Reporting Clinical Trials - Softcover

Shaikh, Saniya; Shetty, Vittaldas; Ambildhok, Kadambari

 
9786208455989: Good Clinical Practice in Clinical trials: Ethical and Scientific Standards for Designing, Conducting, and Reporting Clinical Trials
Softcover
ISBN 10: 6208455987 ISBN 13: 9786208455989
Publisher: LAP Lambert Academic Publishing, 2025

Synopsis

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.

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Publisher
LAP Lambert Academic Publishing
Publication date
2025
Language
English
ISBN 10 
6208455987
ISBN 13 
9786208455989
Binding
Paperback
Number of pages
220