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Handbook of Basic Fundamentals and Regulations of Clinical Trial Site Management

Handbook of Basic Fundamentals and Regulations of Clinical Trial Site Management


₹ 445


Author(s):Dr. J.P. Albin Jose and Mrs. Shreya Kudapane
Paperback ISBN:978-93-90846-69-6
Publisher:AkiNik Publications
Language:English
Pages:79
Publication Year:2021
Binding:Paperback
DOI:https://doi.org/10.22271/ed.book.1178

Price Details
Amount₹ 445

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Payable Amount₹ 445

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Indexed in Crossref Indexed in Dimensions Indexed in Research Access

Description

This comprehensive guide provides an in-depth exploration of clinical research, focusing on its core principles, ethical considerations, and regulatory processes. It offers a detailed understanding of clinical studies, from pre-clinical trials to Phase 1 and beyond, shedding light on the diverse study designs, ethical standards like informed consent, and the roles of various stakeholders, including investigators and medical professionals. The book also discusses the significance of clinical trials in advancing medical science, improving patient care, and enhancing healthcare systems. A must-read for students, professionals, and anyone interested in the complexities of clinical research and development.

Abstract

This book serves as a foundational resource for understanding the nuances of clinical research. It covers essential topics, including the aims of clinical research, ethical principles such as informed consent, commonly used study designs, and the regulatory processes that govern clinical trials. The text emphasizes the importance of maintaining high ethical standards, data integrity, and uniformity in studies. It also examines the different phases of clinical trials, from pre-clinical studies to Phase 1, and the roles of medical professionals, institutions, and ethics committees in conducting safe and effective research.

Reviews

5.0

1 reviews





Dr. Anita Joshi
  November 12, 2024

This book provided me with both theoretical and practical knowledge I can apply in my work.

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