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 ...
Verfasser: | |
---|---|
Dokumenttyp: | Text |
Erscheinungsdatum: | 2021 |
Schlagwörter: | Medicine / Science Policy / Mentoring / Monitoring / Quality Management System / Investigator-initiated trials / Data management |
Sprache: | unknown |
Permalink: | https://search.fid-benelux.de/Record/base-29019064 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://doi.org/10.6084/m9.figshare.14955440.v1 |