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📖 Description
From the historical roots of clinical research, through protocol design and management, this book provides a solid introduction to the research process. The reader is immediately drawn into research through its phases, then introduced to the regulatory framework of clinical research through historical events. Subsequent chapters introduce the reader to ethical behavior and safeguards for subjects in his or her care. The roles of all the key players in the process are described, punctuated by a practical overview of clinical trial management through interactions by both site and sponsor research professionals. After reading this book, the novice will feel confident in his or her understanding of the research process and comfortable through the new skills introduced to manage a clinical protocol.