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Neil Constantine, Ph.D., University of Maryland School of Medicine, Baltimore, Nov. 17 (CBER).(Medical Devices)
Warning Letter Bulletin
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January 1, 2005
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The agency conducted an inspection from July 12-21, 2004, in which FDA inspector Stephanie Shapley reviewed Constantine's conduct as a clinical investigator testing investigational devices in three studies: one involving a known HIV-1-positive population (Study 1); one involving a low-risk population (Study 2); and one involving a high-risk population (Study 3).
The agency determined that Constantine failed to obtain informed consent from 88 of 201 subjects enrolled in Study 3.
Constantine also failed to include one of the basic elements in the informed ...
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