FDA EIR - Brock A. McConnehey, DO - April 02, 2021

An FDA inspection of clinical investigator Brock A. McConnehey, DO, associated with Northwest Clinical Trials in Boise, ID, was conducted from March 29 to April 2, 2021. This surveillance inspection, part of a high-priority mission under the Bioresearch Monitoring (BIMO) program and compliance program 7348.811 for Clinical Investigators and Sponsor-Investigators, focused on a clinical trial for an investigational drug for episodic migraine prevention, supporting an Investigational New Drug (IND) and New Drug Application (NDA). The inspection evaluated adherence to Good Clinical Practice regulations, specifically 21 CFR 312.60.

Key violations, documented in a Form FDA 483, included failure to conduct the investigation in accordance with the investigational plan. Specifically, one subject was randomized and dosed with the study drug while taking a prohibited concomitant medication, a clear protocol deviation. Furthermore, the site failed to report nausea as an adverse event in the electronic case report form (eCRF) for another subject and did not assess its severity, duration, outcome, or relatedness to the study drug. Additionally, there were significant data discrepancies between source documents and eCRFs regarding several concomitant medications and the severity and relatedness of adverse events.

Management, through the clinical investigator, stated plans to inform the sponsor of these deviations and implement a corrective and preventive action (CAPA) plan. This CAPA plan aims to review ongoing studies and prevent similar issues in future research. A formal written response to the FDA 483 was submitted by April 7, 2021. The inspection noted that no immediate corrections were made during the inspection period.