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

Abstract

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].