Research Clinical Research Support Clinical Research Policies

About this team

We develop policy and we advise and support researchers and research staff to, among others, comply with all laws and regulations in the design, conduct and completion of human-related scientific research in which Radboudumc is the sponsor or a participating center.


Contact

Visit us on route 114. Open consultation hour every Monday from 13.00 - 14.00.
+31 (0)24 361 48 94
send mail

Our services for employees and externals


Local feasibility, VGO and WMO-subject insurance

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.

see page

Research monitor accounts for monitor visits by external parties

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.

see page

BROK®

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).

see page

Our services for employees


Integral Quality System for human-related scientific research

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.

see page (intranet)

PaNaMa

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.

see page (intranet)

Radboudumc e-learning human-related research

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

see page (intranet)

WMO-GCP training

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.

see page (intranet)

Radboudumc Basic Monitoring Training

This training allows our employees to monitor research.

see page (intranet)

Research Support Meeting

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

see page (intranet)

Patient information writing training

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

see page (intranet)

Walk-in consultation

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

see page (intranet)