FDA EIR - Ausberto B. Hidalgo, M.D. - December 03, 2021

An FDA inspection of Clinical Investigator Ausberto B. Hidalgo, M.D., operating with Luminous Clinical Research in Pembroke Pines, FL, was conducted from November 29 to December 3, 2021. This pre-announced, comprehensive surveillance inspection, requested by CDER, focused on Protocol GS-US-540-9012, a Phase 3 COVID-19 treatment trial sponsored by Gilead Sciences, Inc. The inspection identified two primary objectionable conditions, resulting in an FDA Form 483. First, Dr. Hidalgo's site failed to conduct the study in accordance with the investigational plan, including missing required COVID-19 test results for multiple subjects and enrolling several subjects who did not meet the protocol's eligibility criteria, with one instance involving an unsupported change to a subject's symptom start date. Second, the site failed to report these significant study protocol deviations to the Institutional Review Board (IRB) prior to their implementation. These violations relate to federal regulations concerning the conduct of investigational studies and the requirement for IRB approval of changes in research activity. Dr. Hidalgo verbally acknowledged the findings and committed to implementing several corrective actions, including developing quality control procedures for laboratory assessments, retraining staff on data integrity principles, establishing a standard operating procedure for data corrections, and ensuring timely shipping of laboratory samples. Additionally, the site committed to improving documentation for COVID-19 testing, including lot numbers, dates, times, and signatures, and establishing training and SOPs for testing quality.