Local 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.

Local 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).

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Steps

  • 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.

  • 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.

  • 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.
     

Fee approval

Applicable if a commercial sponsor is involved. Amount is EUR 1.500,-- (excl. VAT) and includes the use of a research monitor account.

Servicepoint Local feasibility


Angelie de Kadt

Angelie de Kadt
Management assistant

+31 (0)24 366 83 33
contact

Wendy van Eldijk

Wendy van Eldijk
Project assistant

+31 (0)24 366 83 33
contact