Clinical trial site engagement has been advocated as a critical component relating to a study’s performance and success, however, a minimum amount of data supports this connection.

In this article a reader will find quantitative and qualitative approach based on risk-based monitoring (RbM) to assess study site engagement, develop monitoring risk tool-kits and strategies for specific countries and regions. The authors answer the question: “What can study teams do to mitigate pre-inherent site engagement risks in large trials?”