FDA 483 - Moore Clinical Research Inc. - April 02, 2013

Moore Clinical Research, Inc. in Brandon, FL, a clinical investigator, was cited for significant deficiencies during an FDA inspection. Observations included the Principal Investigator's failure to personally supervise the study and delegating screening physicals to unqualified staff. Additionally, the firm failed to promptly report a subject safety concern to the IRB and did not ensure informed consent was provided in language understandable to subjects.