Comparing Methods of Identifying High-Risk Sites

摘要

ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), published in March 2018, states: The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. For years, our company, MSD, has used a home-grown “risk-based auditing” (RBA) tool to evaluate study site risk. The emergence of new, commercially available risk-based monitoring (RBM) tools led us to investigate whether one of those tools could improve study quality.