Clinical Research Policies

For WMO-compliant research in which Radboudumc acts as sponsor or participating center, approval must be granted by the Radboudumc Executive Board prior to the start of the research. We coordinate the approval procedure and assess the content of the file as a means of quality assurance.

We handle the issuance of research monitor accounts for monitor visits by an external party. This allows external monitors, subject to permission, to view and verify data of Radboudumc research participants.

The BROK is a course on regulations and organisation and is mandatory for researchers involved in human-based scientific research that falls under the scope of the Medical Research Involving Human Subjects Act (WMO).

Our researchers can use our IQS (IKS, in Dutch) to obtain info on all phases of clinical research. We also offer a help desk, walk-in consultation and a bi-monthly newsletter.

Human-related research (WMO-compliant, as well as non-WMO) that is conducted in or by Radboudumc must be registered in the research management system PaNaMa.

This e-training has been developed to familiarize our employees involved in human-related research with the Radboudumc policy on human-related scientific research.

Any research employee who falls into the group whose work involves the conduct of research falling within the scope of the WMO, CTR, MDR or IVDR is required to complete a WMO-GCP training.

This training allows our employees to monitor research.

Together with RTC Biobank and RTC Data stewardship we organize regular meetings with a variety of topics and speakers.

We offer training to improve patient information (PIF) writing skills of our researchers and research staff.

If you prefer to talk with us in person, we invite you to our walk-in consultation hours.