FDA EIR - Alexandra Rogers, MD - October 01, 2021

An FDA inspection was conducted at the clinical investigator site of Dr. Alexandra Rogers, MD, in Santa Barbara, CA, from September 27 to October 1, 2021. This "for cause" inspection focused on Dr. Rogers' role as Principal Investigator for a pivotal study (protocol 111-3281) evaluating Valencia Technologies Corporation's eCoin® device for urgency urinary incontinence, under a Premarket Application (PMA) assignment. The regulatory framework for this inspection included Compliance Program 7348.811 for Clinical Investigators and Sponsor-Investigators.

The inspection resulted in an FDA-483, detailing significant objectionable conditions. The primary violations included the failure to report all adverse events experienced by study subjects, contrary to protocol requirements and 21 CFR 812.110(b). Furthermore, Dr. Rogers did not disclose her financial interest to the Institutional Review Board (IRB) as mandated by her investigator agreement and IRB policies.

During discussions, additional issues were identified, such as the under-reporting of concomitant medications, improper use of white-out on study documents, and an incomplete initial IRB submission regarding human research subject protection training and financial interest.

Management, including Dr. Rogers, acknowledged the findings. Required actions included a promise to conduct a comprehensive review of subjects' medical records to identify and report all adverse events to the sponsor. A written corrective and preventive action plan is to be submitted to the FDA within 15 working days, addressing these deficiencies and improving future study conduct and documentation practices.