2013/01/01 by Eva B. Ansmann, Arthur Hecht, Ansmann, Eva B. +7
Economics, Econometrics and Finance · Immunology and Microbiology · Medicine · #610 Medical sciences #Biosimilars and Bioanalytical Methods #Health Systems, Economic Evaluations, Quality of Life #Medicine #Pharmaceutical Economics and Policy #monitoring #quality management #risk-based monitoring
paper · doi:10.3205/000172
openalex publication_date 2013/01/01 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/19
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 site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.