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Clinical Trials Data Management and Quality Control - Panchal, Nilesh
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  • Broschiertes Buch

"Clinical Trials: Data Management and Quality Control" is a comprehensive guide that delves into the critical aspects of managing and ensuring the quality of data in clinical research. It begins with an introduction to data management, highlighting its importance and historical development, and covers essential topics such as designing and implementing data management plans, creating effective case report forms (CRFs), and selecting electronic data capture (EDC) systems. The book provides detailed insights into data entry, verification, cleaning, and validation processes, and explores the…mehr

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Produktbeschreibung
"Clinical Trials: Data Management and Quality Control" is a comprehensive guide that delves into the critical aspects of managing and ensuring the quality of data in clinical research. It begins with an introduction to data management, highlighting its importance and historical development, and covers essential topics such as designing and implementing data management plans, creating effective case report forms (CRFs), and selecting electronic data capture (EDC) systems. The book provides detailed insights into data entry, verification, cleaning, and validation processes, and explores the principles of database design and management. It emphasizes the importance of data quality assurance (DQA), monitoring, and auditing, and addresses the handling of data discrepancies, privacy, and security. Regulatory compliance with frameworks such as FDA, EMA, and GCP, along with the significance of training and education in data management, are thoroughly examined. The book also discusses risk-based data management, the impact of emerging technologies like AI and machine learning, and the challenges of managing data in multinational trials. It integrates patient-reported outcomes (PROs) and real-world data (RWD) into clinical trials, presenting case studies and future perspectives to guide researchers in navigating the evolving landscape of clinical data management.
Autorenporträt
Dr. Nilesh Panchal is a distinguished Public Health Practitioner and Health Scientist with over two decades of experience, making significant contributions to the fields of infectious diseases, mental health, and public health education. Holding a DrPH in Public Health Practice, Dr. Panchal is a prolific author known for his ability to translate complex medical concepts into accessible and engaging content for a broad audience. His work, including the acclaimed series "Global Outbreaks: The Saga of Humanity's Health Battles," provides invaluable insights into the challenges posed by infectious diseases, making it an authoritative source for understanding humanity's ongoing battle against deadly pathogens. Dr. Panchal's dedication to educating the public extends to his "Mindfulness and Well-Being Series," where his compassionate and practical approach empowers readers to enhance their mental and emotional well-being. In addition to his focus on infectious diseases and mental health, Dr. Panchal has made remarkable strides in lifestyle medicine, particularly in the prevention of diabetes. His book series "Healthy Living, Healthy Future: Diabetes Prevention Series" offers evidence-based strategies that empower individuals to make lasting lifestyle changes for a healthier, diabetes-free life. Dr. Panchal's commitment to public health is also reflected in his guide "Essential First Aid: Life-Saving Techniques for Everyone," where he provides clear, step-by-step instructions for managing emergencies. Through his extensive research, Dr. Panchal continues to be a respected voice in global health, contributing to medical journals, speaking at international conferences, and leading health innovation projects aimed at integrating AI into clinical practice. His body of work not only informs but also inspires, making a lasting impact on global health practices and public education.