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
Overview of the required documents
Radboudumc is the sponsor/initiator Radboudumc is participating center Application through PaNaMa Application through PaNaMa Approval ethics commitee Approval ethics commitee Approval competent authority, if applicable
(only in case of drug research)Approval competent authority, if applicable
(only in case of drug research)A-number of the Clinical Trial Agreement
(assigned by the Valorisation Department)A-number of the Clinical Trial Agreement
(assigned by the Valorisation Department)Protocol (approved) Protocol (approved) Datamanagement plan* ABR-form Monitoring plan* Research subject/representative information
leaflet including informed consent form
(please always use the last template version
of the CCMO)Declaration of expertise* (concerning BROK-
registration)Declaration of expertise* (concerning BROK-
registration)Radiation Ethics form*, approved by the
clinical physicist of the Radboudumc. In
case there is a higher dose for the test
subject in the context of the study.Radiation Ethics form*, approved by the
clinical physicist of the Radboudumc. In
case there is a higher dose for the test
subject in the context of the study.
* For Radboudumc employees templates of these documents are in the Integral Quality System (IQS).
The Service point Local Feasibility checks the documents for completeness and accuracy. You will be contacted in case of questions. -
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).
For the record we would like to point out that only that research may only be started after approval by the Board of Directors.
