Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 96

In this overview, we answered the questions: Who are the main players involved in the conduct of clinical research? and, How do the main players interact with each other in the clinical research arena? The activities of the Sponsor, Investigator, IRB/IEC, and Regulatory Authority are regulated; and the Regulatory Authority has complete oversight of the Sponsor, Investigator, and IRB. We note that they all are responsible in some way to ensure the protection of the rights, safety, and well‐being of the research subject, for whom there are no regulatory “responsibilities” because their participation in a trial is completely voluntary, with the option to discontinue at any time. The GCP responsibilities of each of the players are be addressed in greater detail in separate chapters.