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Essentials of Good Clinical Practice ( GCP )1st/2026

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  • G N Dakhale, M V Kalikar
  • 9788181915894
  • Paras Medical Publisher
  • 1st
  • 2026
  • 0.4 K.g.
  • 239
  • Paper Back
  • New
  • In Stock
400.00 425.00

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Essential GCP: Compliance, Quality Research, Clarity, Confidence. Achieve Clinical Excellence with Essential GCP! Why Read & Recommend? This book is a comprehensive and practical compilation that unifies the various National and International guidelines, regulations, and ethical frameworks governing clinical trials and biomedical research. It functions as an essential ready reference for all key stakeholders in clinical research, specifically investigators, ethics committee members, sponsors, and medical students. A distinctive feature is its ability to integrate key provisions from multiple authoritative sources, including ICH-GCP, Indian GCP, ICMR Guidelines 2017, New Drugs and Clinical Trials (NDCT) Rules 2019, and related documents. Each chapter is developed by experienced academicians and researchers, who have distilled complex regulatory content into a concise, comprehensible, and contextually relevant manner. Another unique element is the incorporation of multiple-choice questions (MCQs) and case scenarios in selected chapters, designed to foster self-assessment and application-based learning. These additions make the book not only informative but also highly interactive and suitable for comprehensive teaching and training. The book mandates ethical and regulatory compliance in every aspect of clinical research, spanning from informed consent and ethics committee functioning to sponsor and investigator responsibilities, SAE reporting, compensation, and research involving vulnerable populations. It also addresses emerging topics such as the ethical deployment of artificial intelligence in biomedical research and the accreditation of ethics committees by NABH. Positioned to serve both as a learning resource and a practical guide, this volume empowers readers to easily master the essential elements of Good Clinical Practice as applicable in the Indian setting, while maintaining alignment with global standards.

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Essentials of Good Clinical Practice ( GCP )1

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