Assuring data quality in investigator-initiated trials in dutch hospitals: Balancing between mentoring and monitoring

The complexity of regulations governing investigator-initiated trials (IITs) places a great burden on hospitals. Consequently, many hospitals seek to alleviate regulatory pressures by seeking an alternative quality management system (QMS). This paper takes the Netherlands as a case. To investigate how QMSs for IITs are organized in Dutch hospitals, we adopted the theoretical concepts of mentoring and monitoring in a mixed methods study in the period 2014–2018. In clinical practice and international guidelines, monitoring is seen as the standard quality assurance for ongoing trials. However, ho... Mehr ...