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Role of team Clinical Research Policies
We coordinate the Radboudumc Executive Board’s approval procedure and assess the content of the file as a means of quality assurance (safety of the research participants, quality of the research data and expertise of the research team).
Roadmap
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The application local feasibility, the application WMO subject insurance and the application signature by the Radboudumc Executive Board on the Suitability Declaration (VGO) are submitted through the project registration system PaNaMa. Its manual is published in the Integral Quality System for scientific human-related research (IQS) (please note: only available for Radboudumc employees).
External applicants for local feasibility need to contact their contact person at the relevant Radboudumc department.
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Once the Radboudumc Executive Board has granted approval regarding the conduct of the study, the Radboudumc principal investigator will receive the signed approval letter from the Executive Board by email (a copy of the approval letter will be sent to the local feasibility applicant).
Mediation costs
In case of an application for local feasibility for a study of which the sponsor is a commercial party (the so-called ‘4e geldstroom-projecten’), the costs are € 1,553. (excluding VAT).
read moreMediation costs
In case of an application for local feasibility for a study of which the sponsor is a commercial party (the so-called ‘4e geldstroom-projecten’), the costs are € 1,553. (excluding VAT).
The Radboudumc is responsible for research conducted in or on behalf of the Radboudumc. To safeguard this responsibility, the Radboudumc Executive Board has requested the Local Feasibility Service Point to carry out a mandatory local feasibility check (the so-called 'green light' check). The costs for this local feasibility check are submitted to the relevant Radboudumc department, which passes them on to the sponsor/’verrichter’ of the study.
As Radboudumc, we have chosen not to charge any costs for issuing the VGO from the Local Feasibility Service Point, but we do charge after completion of this 'green light check'.
