Comparison of Non-Commercial Risk Based Monitoring Tools by Their Application on Clinical Trial Protocols |Biomedgrid

Clinical trial monitoring involves intensive on-site monitoring visits at clinical trial sites and exhaustive source data verification (monitoring) of clinical trial data [1]. Clinical researchers have questioned the validity and necessity for traditional monitoring methods [2], which have been under investigation due to their ineffectiveness in improving the quality of clinical trial data or in protecting trial participants [3]. Implementing a risk based monitoring (RBM) system is suggested by the ICH's newly adapted guidelines to improve overall quality management [3]. The RBM involves the identification of any risk that might have an effect on areas routinely subject during monitoring activities. Risks should be identified by a RBM system followed by an evaluation of their likelihood of occurring and the extent to detect these errors and their impact on human subject protection, trial data reliability, and GCP- and protocol compliance [4]. To date various tools for risk identification have been developed with both in paper based or electronic RBM [5,6]. These tools have been compared on their characteristics and the strategy to decrease risk. However the application and subsequent effectiveness of RBM tools is yet to be examined [6]. The aim of this research is to apply each non-commercial RBM tool to clinical protocols and compare the potential risks detected in each, additionally the overall risk assessment of the protocols. Here we show that RBM tools result in different overall risk assessment when applied to the same clinical trial protocols, interestingly, each RBM tool detected distinct risks which thus resulted in a variation in the outcome mitigation.