Top three reasons for FDA 483 Warning Letters to Clinical Investigators
A review of 2012, 2013, and 2014 warning letters to clinical investigators shows three areas that occurred most often:
Failure to abide by the following:
Conduct and supervision of clinical trials
Maintenance of accurate case histories
First - Failure to personally supervise clinical investigations
This was the most common reason for the warning letters to clinical investigators. It is related to a commitment made in FDA Form 1572. Many investigators do not appear to realize the implications of signing this form in terms of their commitment, see [21 CFR 360].
Second - Failure to maintain accurate case histories
The second most frequent reason for FDA 483 was failure to maintain adequate and accurate case histories. The clinical investigator failed to provide accurate records of observations.
Third - Failure to obtain informed consent
The third most common reason for the warning involved informed consent. The clinical investigators received the following violation in their letters: You failed to obtain informed consent in accordance with the provisions of 21 CFR Part 50 [21 CFR 312.60].
Except as provided in 21 CFR 50.23 and 21 CFR 50.24, no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative [21 CFR 50.20]. This item/regulation is the first point listed in the Nuremberg Code.