Please read a very insightful post about some of the studies looking at RBM vs. Traditional Monitoring, specifically the ADAMON and OPTIMON projects. Please Help us all quote and/or use information to promote better decisions and information sharing. Thanks to Laurie Meehan.
Some highlights: "Risk assessment was at the study level, not the site. Yes, some site characteristics might impact the tasks performed at the on-site visits, but site attributes were not part of the initial determination about monitoring frequency or SDV percentage. Also, the studies were all either government, academic, or investigator-initiated. These types of studies have typically had a lot less monitoring than their industry/commercial counterparts. This all affects the value of the information about how traditional and risk-based monitoring compare."
Happy Reading. Please feel free to pass it on. Please subscribe to our new LinkedIn group: Quality Systems for Clinical Research Sites! We are new. Thanks!