FDA EIR - Lora J. McGill, M.D., PI - October 18, 2007

An FDA "For Cause" inspection was conducted at Lora J. McGill, M.D., part of Clinical Neuroscience Solutions Inc., in Memphis, TN, from October 16-18, 2007. This inspection, under Compliance Program 7348.811 for Clinical Investigators, was initiated by a complaint regarding a subject's exclusion from an ongoing clinical study due to a disputed positive test result for an undisclosed condition. The primary issue involved a potential study subject who was rejected after testing positive, but maintained they were negative. The FDA investigation found it plausible that the blood sample could have been contaminated at the study site or the subject might actually be positive, noting that a fresh sample was not obtained to resolve the discrepancy. Additionally, the report highlighted a lack of documented IRB notification for a serious adverse event that led to a subject's withdrawal. A separate instance of a laboratory technician using an incorrect blood collection tube was also noted. Despite these findings, no formal FDA-483, indicating objectionable conditions, was issued. The investigator noted that any deficiencies previously identified by the site's monitor were considered correctable. Dr. McGill expressed an intent to follow up with the complainant regarding the communication around the test results, after consulting with the study sponsor.