Preventing Protocol Deviations With Simulation-Based Training

By David Hadden, President & Founder of Pro-ficiency

Protocol deviations can have a devastating impact on the quality and integrity of key study data and potentially affect patient safety. And there can be serious regulatory repercussions for failing to follow the protocol precisely, as well. Taking the right approach when training investigators, research coordinators and other key staff can be critical to avoiding protocol deviations.

And simulation-based training in particular allows research staff to practice a protocol and all its nuances in advance of applying it to real patients and real data, with the associated real potential risks. And in addition to identifying and addressing protocol deviation risks, the designed scenarios can allow research staff to learn how to prevent the issues that lead to deviations before they occur.