Local feasibility Clinical studies
The RTC Clinical studies coordinates the procedure for obtaining approval from the Board of Directors of Radboudumc for the execution of (mono and multicenter) trials falling under the Medical Research Involving Human Subjects Act (WMO).
read moreLocal feasibility Clinical studies
The Radboudumc Technology Center (RTC) Clinical Studies coordinates the procedure for obtaining approval from the Board of Directors of Radboudumc for the execution of (mono and multicenter) trials falling under the Medical Research Involving Human Subjects Act (WMO) and running within the Radboudumc.The procedure for obtaining approval assesses local feasibility of the study and serves as a quality assurance of trials executed within the Radboudumc as it ensures:
- safety of the study participants;
- quality of the trial data;
- expertise of the (principal) investigators.
Steps
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The application Local Feasibility and the application for insurance certificates is submitted through PaNaMa. The instructions are published in the Integral Quality system for scientific research.
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Stap 1: Application
The application Local Feasibility and the application for insurance certificates is submitted through PaNaMa. The instructions are published in the Integral Quality system for scientific research.
Employees of the Radboudumc need to apply through the research project management system PaNaMa.
External applicants for the local feasibility can contact the Service Point local feasibility, tel. +31 (0)24 366 83 33. -
Here you can find an overview of the required documents.
see overview
Step 2: Filling the documents
Required documents
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Upon approval by the Board of Directors for execution of the trial within the Radboudumc, the approval letter will be signed and sent to the principal investigator of the Radboudumc.
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Step 3: Approval Board of Directors
Upon approval by the Board of Directors for execution of the trial within the Radboudumc, the approval letter will be signed and sent to the principal investigator of the Radboudumc (a copy of the approval will be sent by e-mail to the contact persons).
