FDA EIR - Kathryn Lucas, M.D. - April 08, 2016

An FDA inspection of Kathryn Lucas, M.D., located at 611 N 35th St, Morehead City, NC, was conducted from April 5 to April 8, 2016. This inspection was initiated by the Office of Scientific Investigations, Center for Drug Evaluation and Research, under Compliance Program 7348.811, which focuses on Clinical Investigators and Sponsor-Investigators. The purpose was to evaluate Dr. Lucas's site (Site 14842/704) regarding the Novo Nordisk study NN1218-3852, titled "Efficacy and Safety of FIAsp compared to insulin aspart both in Combination with insulin detemir in Adults with Type 1 Diabetes." The inspection scrutinized various aspects including the clinical investigation's authority, protocol adherence, Institutional Review Board (IRB) oversight, subject eligibility, informed consent procedures, investigational product accountability, and adverse event reporting. A significant issue identified during this inspection was the enrollment of subjects who did not meet the study's eligibility criteria. This finding resulted in the issuance of a Form FDA 483, detailing these observations. It was also noted that a previous inspection in May 2015 had identified deficiencies, specifically related to not adhering to the investigational plan and failing to maintain adequate case histories. The current Form FDA 483 signifies the need for the clinical investigator to address and correct the identified issues to ensure compliance with regulatory requirements and study protocols.