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About
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.
This is called the Local feasibility procedure and this needs to be requested internally by the Radboudumc investigator via the research management system PaNaMa.
Signature by the Radboudumc Executive Board of the Suitability Declaration (VGO) can also be requested from us through PaNaMa (in the case of WMO-obligatory research), as well as a certificate of the WMO trial subject insurance.
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 the case of an application for local feasibility for a study of which the sponsor is a commercial party (4th flow of funds projects), the costs are 1,500 euros (excluding VAT).
