FDA EIR - E. Clinton Lawrence, MD - November 29, 2005

An FDA inspection of E. Clinton Lawrence, M.D., located in Atlanta, GA, was conducted on various dates in November 2005 (11/02-09, 18, 22, 29/05). The inspection, performed under regulatory guidance for Clinical Investigators (CP 7348.811), reviewed Dr. Lawrence’s participation in a clinical trial for pulmonary arterial hypertension. Deficiencies, documented in an FDA Form 483, included multiple violations of the investigational plan. Dr. Lawrence failed to obtain required sponsor exceptions for eight subjects who did not meet study inclusion/exclusion criteria, and screening or baseline procedures were incomplete for five subjects prior to randomization. Records for the six-minute walk test lacked start/stop times for numerous visits, and investigational drug disposition records were inadequate, showing discrepancies and a lack of proper reconciliation. Furthermore, three serious adverse events (SAEs) were not reported to the sponsor and IRB within the required timeframes, and continued IRB approval for the study was not obtained before its expiration in January 2005. Dr. Lawrence acknowledged the findings, attributing some issues to staff transitions and insufficient oversight. He had previously voluntarily suspended enrollment in other studies to improve procedures and paperwork. He indicated that corrective actions, including new staff, additional training, and consultation with Emory's Office of Research Compliance, were implemented. Emory University also initiated revisions to its overall research procedures. A written response to the FDA 483 was submitted by Dr. Lawrence.