Just hearing the word “risk” can make people feel anxious, so it’s natural that the term “risk-based monitoring” conjures up concern. But, in reality, RBM is actually about mitigating risk in clinical trials.
In an RBM strategy, rather than treating all sites and source data equally, the monitoring that’s performed (on-site and remote) is focused on the sites that need the most help and the data that’s most critical to the study or most likely to be recorded wrong.
So, you see, by focusing the resources you have on the areas that need the most support, you actually reduce the overall risk of your clinical trials.
