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Essentials of Good Clinical Practice (GCP) | GN Dakhale, MV Kalikar, CM Kamaal | 1st Edition | Paras Medical Publishers (English Medium)
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| 361-425 |
The book "Essentials of Good Clinical Practice (GCP)" is a comprehensive guide for healthcare professionals involved in clinical research. Authored by GN Dakhale, MV Kalikar, and CM Kamaal, this 1st edition published by Paras Medical Publishers is designed to provide a thorough understanding of the principles and practices of good clinical practice. Good Clinical Practice (GCP) is a set of international ethical and scientific quality standards that ensure the protection of human subjects participating in clinical trials. This book covers all aspects of GCP, including regulatory requirements, study design, data collection and management, monitoring procedures, adverse event reporting, and ethical considerations. It also discusses the roles and responsibilities of various stakeholders in clinical research, such as investigators, sponsors, ethics committees, and regulatory authorities. The authors have drawn upon their extensive experience in clinical research to create a practical and user-friendly resource for healthcare professionals seeking to enhance their knowledge and skills in GCP. The content is presented in a clear and concise manner, with key concepts highlighted for easy reference. Case studies and real-life examples are included throughout the book to illustrate important principles and best practices. Whether you are a novice researcher looking to establish a solid foundation in GCP or an experienced professional seeking to refresh your knowledge and stay current with industry standards, this book is an invaluable tool. It serves as a valuable reference guide for anyone involved in the conduct or oversight of clinical trials. In summary, "Essentials of Good Clinical Practice (GCP)" offers a comprehensive overview of the essential elements of GCP that are crucial for ensuring the integrity and validity of clinical research. With its practical insights and expert guidance, this book is an indispensable resource for healthcare professionals striving to uphold the highest standards of ethical conduct and scientific rigor in their work.
Essentials of Good Clinical Practice (GCP) is a comprehensive and practical guide designed to provide a clear understanding of ethical and scientific standards in clinical research. Written by experienced authors GN Dakhale, MV Kalikar, and CM Kamaal, this book is published by Paras Medical Publishers and serves as an essential academic resource for students and professionals involved in clinical trials and biomedical research.
Good Clinical Practice (GCP) is an internationally recognized ethical and scientific quality standard that governs the design, conduct, recording, and reporting of clinical trials involving human subjects. This book explains the fundamental principles of GCP in a simple, structured, and easy-to-understand manner, making it highly suitable for beginners as well as advanced learners in the medical field.
The content covers all essential aspects of clinical research, including ethical considerations, informed consent, protocol development, investigator responsibilities, regulatory guidelines, data management, and safety monitoring. It also highlights the importance of protecting the rights, safety, and well-being of trial participants, which is the core principle of GCP.
This edition is especially useful for MBBS students, MD/MS scholars, pharmacy students, clinical researchers, and healthcare professionals who are involved in or planning to enter the field of clinical research. It also helps learners prepare for academic exams, interviews, and professional certifications related to clinical trials and pharmacovigilance.
One of the key strengths of this book is its simplified explanation of complex regulatory frameworks. It bridges the gap between theoretical knowledge and practical application in clinical research settings. The book includes structured chapters, flowcharts, tables, and real-world examples that make learning more effective and engaging.
With 240 pages of well-organized content, this paperback edition provides a strong foundation in Good Clinical Practice guidelines as per global standards. It helps readers understand how clinical trials are conducted ethically and scientifically in compliance with regulatory authorities.
Whether you are a student beginning your journey in clinical research or a healthcare professional aiming to strengthen your understanding of trial protocols, this book is a valuable academic companion.
| SKU / BOOK Code: | PARAS-GCP-CLINICAL-001 |
| Publisher: | Paras Medical Publishers |
| Author: | GN Dakhale MV Kalikar CM Kamaal |
| Binding Type: | Paperback |
| No. of Pages: | 240 |
| ISBN-10: | NA |
| ISBN-13: | NA |
| Edition: | 1st |
| Language: | English Medium |
| Publish Year: | 2026-01 |
| Weight (g): | 300 |
| Product Condition: | New |
| Reading Age: | Above 18 Years |
| Country of Origin: | India |
| Genre: | Medical Books |
| Manufacturer: | Paras Medical Publishers |
| Importer: | Paras Medical Publishers |
| Packer: | Fullfilled by Supplier |
The book "Essentials of Good Clinical Practice (GCP)" is a comprehensive guide for healthcare professionals involved in clinical research. Authored by GN Dakhale, MV Kalikar, and CM Kamaal, this 1st edition published by Paras Medical Publishers is designed to provide a thorough understanding of the principles and practices of good clinical practice. Good Clinical Practice (GCP) is a set of international ethical and scientific quality standards that ensure the protection of human subjects participating in clinical trials. This book covers all aspects of GCP, including regulatory requirements, study design, data collection and management, monitoring procedures, adverse event reporting, and ethical considerations. It also discusses the roles and responsibilities of various stakeholders in clinical research, such as investigators, sponsors, ethics committees, and regulatory authorities. The authors have drawn upon their extensive experience in clinical research to create a practical and user-friendly resource for healthcare professionals seeking to enhance their knowledge and skills in GCP. The content is presented in a clear and concise manner, with key concepts highlighted for easy reference. Case studies and real-life examples are included throughout the book to illustrate important principles and best practices. Whether you are a novice researcher looking to establish a solid foundation in GCP or an experienced professional seeking to refresh your knowledge and stay current with industry standards, this book is an invaluable tool. It serves as a valuable reference guide for anyone involved in the conduct or oversight of clinical trials. In summary, "Essentials of Good Clinical Practice (GCP)" offers a comprehensive overview of the essential elements of GCP that are crucial for ensuring the integrity and validity of clinical research. With its practical insights and expert guidance, this book is an indispensable resource for healthcare professionals striving to uphold the highest standards of ethical conduct and scientific rigor in their work.
Essentials of Good Clinical Practice (GCP) is a comprehensive and practical guide designed to provide a clear understanding of ethical and scientific standards in clinical research. Written by experienced authors GN Dakhale, MV Kalikar, and CM Kamaal, this book is published by Paras Medical Publishers and serves as an essential academic resource for students and professionals involved in clinical trials and biomedical research.
Good Clinical Practice (GCP) is an internationally recognized ethical and scientific quality standard that governs the design, conduct, recording, and reporting of clinical trials involving human subjects. This book explains the fundamental principles of GCP in a simple, structured, and easy-to-understand manner, making it highly suitable for beginners as well as advanced learners in the medical field.
The content covers all essential aspects of clinical research, including ethical considerations, informed consent, protocol development, investigator responsibilities, regulatory guidelines, data management, and safety monitoring. It also highlights the importance of protecting the rights, safety, and well-being of trial participants, which is the core principle of GCP.
This edition is especially useful for MBBS students, MD/MS scholars, pharmacy students, clinical researchers, and healthcare professionals who are involved in or planning to enter the field of clinical research. It also helps learners prepare for academic exams, interviews, and professional certifications related to clinical trials and pharmacovigilance.
One of the key strengths of this book is its simplified explanation of complex regulatory frameworks. It bridges the gap between theoretical knowledge and practical application in clinical research settings. The book includes structured chapters, flowcharts, tables, and real-world examples that make learning more effective and engaging.
With 240 pages of well-organized content, this paperback edition provides a strong foundation in Good Clinical Practice guidelines as per global standards. It helps readers understand how clinical trials are conducted ethically and scientifically in compliance with regulatory authorities.
Whether you are a student beginning your journey in clinical research or a healthcare professional aiming to strengthen your understanding of trial protocols, this book is a valuable academic companion.
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