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Explore the complexities of clinical research regulations in this comprehensive volume, Clinical Research Regulations: Principles, Practices, and Global Perspectives. Edited by Prof. Rajiv Dahiya and authored by Dr. Muralidhar Rao, this book offers an in-depth look at the legal and ethical frameworks governing clinical trials across the globe.
Spanning 25 chapters, the book covers essential topics including phases of clinical trials, ethical considerations, and global regulatory standards. It provides a structured approach, making it a go-to reference for pharmacists, researchers, and regulatory professionals.
This guide emphasizes international guidelines, ensuring readers stay informed about the FDA, EMA, and ICH-GCP regulations. It also addresses emerging trends in medical device investigations and biostatistical applications, making it a must-read for those involved in the clinical research process.
This text is a valuable resource for anyone looking to stay abreast of the evolving landscape of clinical trials and global harmonization efforts in clinical research.
Key Features:
Phases 0-IV of Clinical Trials
Global Regulatory Standards (India, USA, EU)
Ethics in Clinical Research
Medical Device Clinical Investigations
Comprehensive Biostatistics for Clinical Research
Informed Consent Process & Documentation
Role of Institutional Review Boards (IRBs) and Data Safety Monitoring Boards (DSMBs).
