The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles

Eva B. Ansmann, Arthur Hecht, Doris K. Henn, Sabine Leptien & Hans Günther Stelzer
Since several years risk-based monitoring is the new “magic bullet” for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at...