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.