Protocol deviations can pose serious risks to clinical trials, including regulatory troubles, study delays and, ultimately, failure to launch an approved investigational product. But despite the importance of following study protocols, deviations remain a consistent problem in the industry, regularly topping the list of problems found during FDA inspections of research sites. Recent figures indicate that the average phase 3 trial has 118.5 deviations per protocol that affect nearly 33 percent of enrolled participants.