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.
Phone number +31 (0)24 361 48 94
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Expertises and services
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)Ethical review of nWMO research
The CMO Radboudumc is a local committee of Radboudumc that assesses a specific type of non-WMO research (only for Radboudumc).
see page (Dutch)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 pageEducation and training
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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).
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This training allows our employees to monitor research.
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This e-training has been developed to familiarize our employees involved in human-related research with the Radboudumc policy on human-related scientific research.
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We offer training to improve patient information (PIF) writing skills of our researchers and research staff.
see page (intranet)
Additional support
We work closely with two other teams that provide support for clinical research.
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This team provides qualified monitors to be used for research commissioned by Radboudumc. Its monitors can be involved for any type of research. In moderate- and high-risk studies, you are required to engage our team for monitoring.
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This team provide qualified personnel, research rooms and equipment needed to conduct clinical research according to applicable laws, regulations and policies. It provides customized support for start-up and implementation of any type of human-related research.
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