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).

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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.

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 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).


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-van den Akker
management assistant

+31 (0)24 361 48 94
contact form

Wendy van Eldijk

Wendy van Eldijk
project assistant

+31 (0)24 361 48 94
contact form

Nasha Kayanersy

Nasha Kayanersy
project assistant

+31 (0)24 361 48 94
contact form