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About

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.

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Research Human Research Compliance

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.

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Contact

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

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.

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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.

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Education and 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)

Additional support

We work closely with two other teams that provide support for clinical research.

  • 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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