Clinical research monitoring
The sponsor (in Dutch verrichter) of the study is responsible for ensuring that the study is adequately monitored. For all investigator initiated studies initiated by Amsterdam UMC that are subject to the Medical Research (Human Subjects) Act (WMO) independent monitoring is provided for by the Executive Board and delegated to the Clinical Monitoring Center.
Monitoring at Amsterdam UMC for investigator initiated studies is free of costs in case of;
- Monocentre studies
- Monitoring at Amsterdam UMC location AMC/VUmc (sponsor site) in case of multicentre studies.
The CMC website provides information about how to request monitoring, as well as on the associated costs in case of participating sites and other types of services and support offered by the CMC.
During the study, monitoring is performed as described in the monitoring plan. For planning purposes, the monitor will periodically touch base with the contact for the study team.The frequency also depends on the number of subjects, the design and risk classification of the study and the results of the previous monitoring visit. The CMC website provides an overview of the preparations that precede a monitoring visit.
see CMC website for information