FDA EIR - Valerie K Arnold MD - March 15, 2017

An FDA inspection of Valerie K Arnold MD, a clinical investigator based in Memphis, TN, was conducted from March 13-15, 2017. This pre-announced PDUFA inspection was performed in accordance with FDA's Compliance Program 7348.811 for Clinical Investigators, aiming to assess the site's adherence to regulatory standards for clinical trials. The inspection's scope included a comprehensive review of two specific study protocols, examining 100% of source documentation against data line listings for all subjects. Key areas scrutinized were subject eligibility, informed consent processes, adverse event reporting, test article accountability, and overall compliance with study protocols. The inspection concluded with a highly favorable outcome, as no objectionable conditions or significant deficiencies were noted. Records were consistently found to be complete, legible, organized, and accurate. All study activities were conducted in full compliance with the protocols, with no evidence of under-reporting of adverse events, lapses in Institutional Review Board (IRB) approvals, or financial conflicts of interest. A minor observation was raised regarding a slight discrepancy in the calculation of blood pressure limits for a pediatric trial using protocol appendices; however, this had no impact on the study data. Management committed to addressing this through future training initiatives. No regulatory actions were required as a result of this inspection.