FDA Warning Letter: A Weighty Matter

The most common citation on FDA Warning Letters to clinical investigators at clinical trial locations is failure to follow the investigational plan or protocol. In this January 2009 Warning Letter this is the first citation, albeit with a unique twist. The researchers based the patients’ weight based on their drivers licenses. They didn’t weigh the research subjects before calculating the investigational drug dose, which was based on the person’s weight.

Clinical trials

Patient Safety Comes First

When people are seriously ill they frequently lose weight. The weights of the patients were sometimes much lower than the weight on their driver’s license. Simply amazing. This brings up the question of qualified staff for clinical trials, a subject I’ve addressed before. See the article on Supervisory Responsibilities of Investigators on the right. And read for yourself about the drivers licenses (page 2: “ii With respect to Subject –”

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