UMC Utrecht as a local participating centre
UMC Utrecht as a local participating centre
Which steps need to be taken to add UMC Utrecht as a participating centre for a study which has already been reviewed by a different MREC?
Step-by-step plan: UMC Utrecht as a local participating centre uitklapper, klik om te openen
The local feasibility procedure is about to change. At the moment, the new procedure is not yet mandatory (likely to take effect in the summer of 2021). The amended procedure applies to all research that is subject to the WMO in the Netherlands, both researcher and company-initiated and for monocenter as well as multicentre research.
More information can be found on the website of the CCMO.
There are currently 2 options:
- A. Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO)
- B. Research declaration (OV) and Permission from the Executive Board
A. Certificate of Suitability for Research Institution uitklapper, klik om te openen
If the VGO procedure is followed, conditional permission from the Executive Board is requested at the secretariat of the Executive Board, prior to submission of the research file to the Review Committee.
This application goes directly to the Executive Board and does not go to the secretariat of the Research Review Department. Subsequently, the signed VGO is added to the research file for assessment by the Review Committee (MREC or CCMO).
After approval by the Review Committee, the investigator sends a request for registration of the study to the secretariat of the Research Review Department by e-mail (this step is not necessary if MREC Utrecht is the Review Committee):
Always contact the Division's Quality Coordinator Research before starting the VGO procedure in the UMC Utrecht.
B1. Research declaration uitklapper, klik om te openen
- If UMC Utrecht is a local participating center, the local researcher will request a research declaration (OV) through the head of the department.
- The OV must be sent by the investigator to the central principal investigator together with the documents to be used locally, for assessment by the Review Committee (Toetsings Commissie, TC).
- The decision of the TC regarding the participation of UMC Utrecht will go to the central principal investigator. The central principal investigator will inform the local researcher at UMC Utrecht with a copy of the decision.
For the exact working method within your division, consult the Research Quality Coordinator of your division.
B2. Permission from the Executive Board uitklapper, klik om te openen
A study at UMC Utrecht may not start without permission from the Executive Board. After the review committee has positively assessed the participation of UMC Utrecht, the local researcher must request permission from the Executive Board using the permission form.
The local researcher asks the Executive Board of UMC Utrecht via the secretariat of the Research Review Department for permission to carry out the work at UMC Utrecht.
The Executive Board gives written permission to the local researcher to carry out the research at UMC Utrecht, which is a condition for starting the study.
The form can be submitted in PDF format as an attachment to an e-mail at the secretariat of the Research Review Department
After the permission uitklapper, klik om te openen
Amendments, SUSARs, SAEs and progress reports must be submitted by the sponsor to the Review Committee for assessment. If the Review Committee is not the MREC Utrecht, the MREC Utrecht does not need to receive these documents and / or reports. If the MREC Utrecht nevertheless receives these documents and / or reports, it will archive them without sending a response to the sender. This, therefore, does not imply approval from the MREC Utrecht. It is then assumed that the Review Committee will assess those amendments and / or reports.
Exception: please inform MREC Utrecht of:
- The start date of the study (date of first inclusion)
- The end date of the study (date of last study action on last subject)
- Total number of test subjects at UMC Utrecht: only if the subjects are covered by the UMC Utrecht subject insurance. Please also inform MREC Utrecht if an amendment causes a change in the number of test subjects covered by the UMC Utrecht test subject insurance.
Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology