FDA 483 - Michael Aman PhD - April 26, 2004

An FDA inspection of Michael G. Aman, Ph.D., a clinical investigator at Ohio State University in Columbus, OH, revealed significant issues with research conduct. Observations included implementing changes to research activities without prior Institutional Review Board approval, failure to maintain accurate case histories with discrepancies in clinical data, and not conducting investigations in accordance with the approved investigational plan, specifically regarding the reporting of concomitant medications.