This symposium will explore the changing regulatory landscape and novel approaches to risk-based monitoring. Risk-based monitoring puts new demands on the both the sponsor and investigator site. This symposium will offer solutions to meeting some of the many operational challenges of risk-based monitoring. It will also examine the impact of this guidance on the site from both the site perspective and the site monitoring perspective. It will also provide useful tips for successful site management and the identification of high quality sites that are prepared to thrive in this changing regulatory environment.