FDAnews Drug Daily Bulletin

Subject Enrollment Issues Lead to Investigator Warning Letter

Sept. 21, 2010
The principal investigator for a vaccine trial received a warning letter for enrolling subjects who did not meet the trial criteria, using an obsolete consent form and failing to retain trial records as required. Of the 17 patients Patrick Nemechek enrolled in the investigational vaccine trial, seven did not meet the trial criteria, according to the June 28 warning letter posted recently to the FDA’s website. The osteopathic physician also did not conduct subject testing required by the protocol.
Clinical Trials Advisor