Risk Based Monitoring

Traditional monitoring approach involved 100% source document verification (SDV) of each data points. However this approach of one size fits all has not been found appropriate for every clinical trial. Previous studies have shown that only 2.4 percent of data corrections occur as a result of SDV and hence the industry is witnessing a paradigm shift towards customized monitoring approach as per each clinical trial requirement. Risk Based monitoring assesses the criticality of a site based on critical risk parameters and uses these risk factors to go for on-site monitoring or remote monitoring depending on the severity of the risk. Introduction The industry is aggressively moving towards� Risk Based Approach. With the recent directives by US FDA in its final guidance on RBM and reflection paper by EMA, sponsors and CRO have embraced that the clinical monitoring is the way to go. Adding to it TransCelerate� with its position paper in 2013 and a recent update on it in 2014 gives the clear nod that the RBM is the new� drift� in monitoring space. TransCelerate �describes RBM as ��an adaptive approach to clinical trial monitoring that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact subject safety and data quality.� It is based on awareness that different trials, different data points/processes, and different sites represent differing risks to the product's development.   Author: Sapna Rani