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portada Good Clinical Practice in Clinical trials
Type
Physical Book
Publisher
Author
Language
English
Pages
220
Format
Paperback
Dimensions
22.9x15.2x1.3 cm
ISBN13
9786208455989

Good Clinical Practice in Clinical trials

Shaikh, Saniya; Shetty, Vittaldas; Ambildhok, Kadambari (Author) · LAP Lambert Academic Publishing · Paperback

Good Clinical Practice in Clinical trials - Shaikh, Saniya; Shetty, Vittaldas; Ambildhok, Kadambari

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Synopsis "Good Clinical Practice in Clinical trials"

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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The binding of this edition is Paperback.

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