Researcher Warned for Using Untrained Coordinators

An investigator in a drug clinical trial had two study coordinators who were not medically trained assess inclusion and exclusion criteria, adverse events, serious adverse events and study endpoints in a trial he oversaw, a warning letter issued June 12 and posted recently to the FDA website says. Dov Linzer of HealthwoRx, Pembroke Pines, Fla., told the FDA that since he was inexperienced in conducting clinical trials, he mainly relied on the coordinators to conduct the study and complete the paperwork, according to the letter.
Clinical Trials Advisor