Dp Clinical Inc – FDA EIR, Nov 13, 2017

An FDA "for cause" inspection of DP Clinical, Inc., a Contract Research Organization (CRO) in Rockville, MD, was conducted from November 6-13, 2017. This comprehensive review, the company's first FDA inspection, focused on the firm's responsibilities for an Investigational Device Exemption (IDE) study, following the sponsor's suspension due to multiple subject deaths and protocol deviations. The inspection assessed compliance with federal regulations and guidance for Sponsors, CROs, and Monitors (CPGM 7348.810). While no Form FDA-483 was issued, six significant deviations from investigational plans were discussed with management. Key issues included monitors failing to compare subject exam results against previous visits for study stopping rules and delays in conducting initial interim monitoring visits at several sites. Additionally, four Clinical Research Associates (CRAs) were hired without prior experience, contrary to the company's own position description. The firm also overlooked marking "Death" on MedWatch forms for a fatality and failed to submit MedWatch drafts to the sponsor within the required 24-hour timeframe for serious adverse events. Furthermore, monitoring reports were often finalized and uploaded significantly past due dates, and an incorrect protocol version was used for site training, with an essential site qualification report remaining unsigned. DP Clinical's management acknowledged these issues, committing to immediate corrective and preventative actions to address all identified matters.