What and how will the Risk Based Approach to Monitoring change? Survey of RBM in medical institutions

Abstract

Paralleling the revision and enforcement of regulatory guidance, the Risk-based Approach to Monitoring (RBM) is becoming increasingly important in process management at medical institutions. Although the incorporation of RBM practices is intended to streamline the monitoring of clinical trials, whether it in fact improves the effectiveness of associated duties at participating organizations remains unclear. Regarding RBM and its benefits, we surveyed 391 clinical research coordinators and data managers at Japanese medical facilities. The results of the survey suggest that RBM does in fact decrease the frequency of on-site visits from clinical research associates. Conversely, rather than reducing staff burden as intended, off-site monitoring (by telephone and e-mail) was reported to increase the workload of monitoring personnel. Our survey findings indicate that sponsors need to optimize the use of on-site, off-site, and central monitoring practices to maximize the efficiency of RBM. Regarding central monitoring duties in particular, data regarding the items of “eligibility/enrollment,” “treatment suspension/dose reduction/discontinuation,” and “initial treatment, related PK and tests, etc.” should be checked carefully for errors and omissions, and information entered through electronic data capture mechanisms should be confirmed cross-sectionally.