FDA EIR - Jonathan Rome, MD - January 05, 2016

An FDA inspection of Dr. Jonathan J. Rome, Principal Investigator at The Children's Hospital of Philadelphia, was conducted from December 21, 2015, to January 5, 2016. The surveillance inspection focused on a multi-center clinical trial involving an investigational stent for aortic wall injury. The inspection resulted in a three-item Form FDA 483, identifying significant regulatory violations. First, the investigation was not conducted in accordance with the signed agreement, investigational plan, and IRB conditions. This included multiple missed scheduled assessments, notable discrepancies between source data and electronic records, and missing or late principal investigator signatures on critical documents. Furthermore, the site failed to obtain required assents from mature minors for follow-up fluoroscopies and did not perform mandatory pregnancy tests as stipulated. Second, investigational devices were not properly controlled, evidenced by the loss of a study stent that was mistakenly discarded. Third, an investigational device was improperly supplied to an unauthorized person, as a stent from the study inventory was implanted in a patient enrolled in a different clinical trial. These observations indicate non-compliance with FDA regulations for investigational device exemptions (IDE) and human subject protection. Dr. Rome was issued the Form FDA 483 at the close-out meeting and was required to submit a written response within 15 business days, detailing corrective actions. The discussion underscored the Principal Investigator's ultimate oversight responsibility and raised concerns about inadequate sponsor monitoring.