Abstract T P251: Overseeing a Multicenter Clinical Trial: Our Experience in Creating a New Model

Abstract

The model for overseeing multicenter clinical research trials continues to evolve. In the late 1990’s electronic medical records became more common across institutions. Subsequently, the integration of the World Wide Web into clinical care enhanced the ability to connect clinical and research data across multiple sites. For years, research data has been handled in a hybrid fashion with the use of hard-copy and electronic sources for data entry and verification. Recently, leaders behind multicenter clinical trials have incorporated electronic data capture (EDC) systems in an effort to store multicenter clinical trial data in a secure and structured environment. The implementation of EDC’s has led to better control and accuracy of data; however, many aspects of multicenter clinical trial workflow are still captured in a hard-copy format. Therefore, the oversight of these additional components is still subject to an in-person, on-site review. While the paper-based model focuses on reviewing hard-copies of patient records long after the data originates at the point of care, new models must allow for real-time oversight of clinical trial data. In conjunction, the source documentation needed to recreate the clinical trial data, as well as the ongoing regulatory and compliance documentation associated with a clinical trial, should be readily available for remote review. In order to promote best practice and effectively utilize current technology, the Food and Drug Administration released guidance in August of 2013 encouraging sponsors to focus on risk-based and centralized monitoring techniques. The Cerebrovascular Clinical Research Office (CCRO) at Vanderbilt University has recently implemented a risked-based monitoring model that incorporates a comprehensive electronic trial infrastructure. The CCRO has identified many advantages with the incorporation of this new method. These advantages have led to a significant cost-savings, increased protocol and regulatory compliance, a heightened level of accountability for all involved parties, and a more streamlined approach to ensuring data accuracy. In conclusion, the CCRO’s experience incorporating a new monitoring model has been one full of exciting challenges and opportunities for originality.