Problem: Overrepresentation from Rapidly Enrolling Sites

Study X had a handful of sites that were enrolling rapidly.The study sponsor was concerned that these sites’  data would be over-represented. If the data were unreliable and invalid, then it likely would skew the findings and lead to a failed trial. ProPhase sent trainers to each of the sites to monitor clinical interviews, to ensure that the measures for the study were used properly, and to conduct additional training on interview technique.

Result: Data quality was maintained. The study produced a positive outcome.