Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 135

Among the players in the clinical trial endeavor, the regulatory authority has a unique and highly visible role. Understanding the roles of the regulatory authority whether it is as a gatekeeper approving a trial application or an inspector following up on a complaint, the regulatory authority is in a unique position of control and influence. Placing the roles and responsibilities of the regulatory authority in perspective is therefore meaningful.