The Center for Drug Evaluation & Research / Division of Scientific Investigations sent a Warning Letter to a Kissimmee Florida Clinical Investigator dated 2 February 2009. It is currently posted on the FDA website and there is a link to your right. This Warning Letter looks well-deserved. The FDA Investigator spent an entire month there and looked at three different studies. This suggests that it was a directed inspection and may have been assigned to investigate a complaint.
It starts out with the failure to personally conduct or supervise the study. The study coordinator, who was not delegated the responsibility, determined study eligibility and enrolled subjects who were not eligible. This will get you into trouble every time (Scroll down to see article on Supervisory Responsibilities of Investigators a couple of posts ago).
Next there is the failure to obtain informed consent, specifically to document informed consent in relation to study related procedures.
Third is the failure to follow the investigational plan, the protocol, by violating inclusion/exclusion criteria and failing to perform basic procedures including taking the subject’s blood pressure.
Fourth the investigator failed to maintain adequate and accurate case histories. This is followed by drug accountability violations and the failure to report an SAE as required to the IRB.
All of these violations are to be expected when the investigator fails to take charge and supervise the study. It’s no wonder that FDA paid the good doctor a visit. And it seems that DSI is determined to write Warning Letters when confronted with clear and significant violations of the regulations (see article on 2008 Warning Letters on the right).