NL
DE
About
We are responsible for developing and maintaining the Integral Quality System (IQS). By following the IQS procedures, researchers ensure that all scientific research involving human participants and research with human data/body material complies with legal regulations and meets the ethical and scientific standards of Radboudumc.
read moreAbout
Responsible and high-quality research is a top priority.
Team Human Research Compliance is responsible for developing and maintaining the Integral Quality System (IQS). By following the IQS procedures, researchers ensure that all scientific research involving human participants and research with human data/body material complies with legal regulations and meets the ethical and scientific standards of Radboudumc. The safety and privacy of research participants and the integrity of the research data are paramount in this regard.
Our team is available for questions and advice, enabling researchers to carry out their work with confidence and care.
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 pageResearch 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 pageOur services for employees
BROK and WMO GCP training
Researchers working on research subject to the WMO are required to follow the BROK. Research personnel working on research falling within the scope of the WMO, CTR, MDR or IVDR are required to take WMO GCP training (unless already in possession of a valid BROK certificate).
see page (intranet)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)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)Radboudumc Basic Monitoring Training
This training allows our employees to monitor research.
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)