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Principles and Practices in Clinical Research: Comprehensive Guide to Methodologies, Ethics, and Regulations

Principles and Practices in Clinical Research: Comprehensive Guide to Methodologies, Ethics, and Regulations

Hardcover

Medical ReferenceHistory & Philosophy of Science

PREORDER - Expected ship date September 30, 2026

ISBN10: 1032875186
ISBN13: 9781032875187
Publisher: CRC Press
Published: Sep 30 2026
Pages: 188
Weight: 1.24
Height: 0.50 Width: 7.00 Depth: 10.00
Language: English

This book comprehensively reviews the fundamental principles, ethical considerations, regulatory frameworks, and emerging trends in clinical research. The introductory chapters explore the fundamentals of clinical research, its historical context, and the pivotal role of key stakeholders. The book explores regulatory frameworks in various regions, including the USA, EU countries, non-EU countries, and India. It also delves into the implementation of International Conference on Harmonization (ICH) guidelines, ensuring compliance and quality in clinical trials. It meticulously dissects ethical considerations, delving into historical breaches to underscore the paramount importance of ethical integrity. The chapters outline regulatory standards, emphasize data accuracy and confidentiality, and prepare researchers for regulatory inspections and audits. Moreover, the chapters provide a concise yet comprehensive guide to protocol development and statistical analysis in clinical research. From the inception of research protocols to the intricacies of statistical analysis, the book offers practical insights and methodologies crucial for conducting rigorous and ethically sound research. Moreover, it critically examines emerging trends, from the integration of digital health technologies to the burgeoning role of machine learning and artificial intelligence. This book is intended for researchers, healthcare professionals, and regulatory stakeholders.

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