Stefan Duerr, Associate Director of Project Management, Cenduit
The increased frequency of federal audits, coupled with the complexity of modern clinical trial design, and the growing number of federal regulations governing clinical trials has made drug accountability management more challenging than ever before. The traditional, paper-based methods increase the risk for human error, as well as illicit activity in clinical trials. Failure of an FDA site audit due to insufficient or inaccurate paper-based drug accountability records is common. A failed federal audit leads to costly trial delays to the sponsor, and may result in non-approval of the investigational drug, or criminal liability for the investigator. Electronic drug accountability managed through an IRT system is a cost-effective way to ensure compliance with federal regulations, reduce inefficiencies, preserve the integrity of data and increase patient safety in clinical trials.
Clinical trial sites, both foreign and domestic, have been subjected to an increasing number of FDA audits in recent years. Federal investigators cite non-compliance with federal drug accountability regulations as one of the most common problems found in site audits. A failed site audit is a serious problem for a clinical trial, leading to costly delays, non-approval of the investigational drug, or criminal liability. Ensuring compliance with federal regulations is key to the success of a clinical trial and the entire drug development program.