Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. 

Dr. Tracey was warned for failing to follow the investigational plan, specifically:

  • Enrolling a subject with a positive serum pregnancy test, contrary to the protocol inclusion/exclusion criteria. 
  • FDA notes that Dr. Tracey signed three lab reports which contained the HCG values indicating pregnancy.
  • FDA notes that Dr. Tracey signed a statement verifying that the subject met inclusion/exclusion criteria.
  • FDA notes that the subject was dosed.
  • FDA does not accept Dr. Tracey's explanation that the lab report did not "flag" the HCG value.