FDA Warning Letter Cites Forged Signatures

A study coordinator allegedly forged the signatures of parents or legally authorized representatives for three pediatric subjects on informed consent forms for two Phase IIIb clinical trials of Schering-Plough’s anesthesia drug Zemuron, according to an FDA warning letter to the clinical investigator, Charles Cote. In addition, Cote, of Massachusetts General Hospital’s department of anesthesia and critical care, said he did not sign two of the same subjects’ informed consent forms even though the forms were signed with his name.
Washington Drug Letter