Method of submission
The MREC NedMec reviews applications from researchers in the affiliated institutions as well as from various other researchers and (government) institutions in the health care sector. All communication goes through the principal investigator and/or the contact person of the study concerned.
For investigators from affiliated institutions, a study can only be submitted to the MREC NedMec if the local requirements of the institution where the study will be conducted are met. For more information on the specific procedure of your institution please consult the pages below:
PDF and coding file name uitklapper, klik om te openen
All documents must be submitted digitally in PDF format. The file name of each PDF document should consist of a code (letter and number) and the name associated with the document concerned. Below you will find an overview of the codes and naming examples as a download. This document is supplemented and derived from the overview on the CCMO website and the CCMO standard research file.
Always complete the file name with the date of the document and if applicable a version number.
PDF documents that are secured cannot be processed (even if the password is provided).
Submit new study uitklapper, klik om te openen
NOTE: Until further notice, the original signed (paper) version of the cover letter does not need to be sent by physical post. Please visit the CCMO website for more information.
In the primary submission of a study for review under the WMO it is mandatory to provide a signed Template Cover Letter on paper. Reason for this is that these are applications in the sense of the General Administrative Law Act (Awb) and for a legally valid application a so-called 'wet' signature on paper is required.
Please use the correct cover/response letter template.Scan the signed cover letter as a PDF. Follow the instructions above for the correct file names (PDF and coding file name). The files are then submitted via the Research Portal.
Other submissions
Other submissions, like SAEs, amendments and progress reports are submitted via the Research Portal. Follow the instructions as mentioned on the website of the CCMO
Timeline
The time within which the MREC must make a decision on your application is recorded in the Research Portal. You can also use the Research Portal to follow the remaining time of the decision period.
To ensure that the review process runs as smoothly as possible, the investigator has one month in which to respond to the committee's questions and comments. If it is not possible to have the response ready within this month, you can ask for an extension by e-mail. Please state the reason for the delay.
If you have any questions about the procedure or the timelines please contact the secretariat of MREC
Participating institutions: UMC Utrecht, Prinses Máxima Center for pediatric oncology and Antoni van Leeuwenhoek