Due to the coronavirus, the secretariat of the MREC NedMec uses an adjusted procedure. Keep an eye on this page for updates.
Adjusted procedure uitklapper, klik om te openen
Because of the measures taken to prevent the spread of the new coronavirus, the secretariat mainly works from home. This means that the walk-in consultation hours have been temporarily cancelled. However, we are available by phone during telephone consultation hours on Monday to Thursday from 13.00 - 16.00 hours. You can also reach the secretariat by e-mail. If a consultation is desired, please describe your question in the e-mail and state the telephone number on which you can be reached. We will then answer your question as soon as possible (by phone or e-mail).
Submission of studies
Submission of new files will temporarily be completely digital. See the Method of Submission page for instructions on digital submission.
The requirement for the cover letter with wet signature for primary submissions and substantial amendments has been suspended. Instead, a digital or scanned signature of the submitter will be sufficient. This also applies to appeals and objections.
Accelerated procedure (fast-track) assessment of research files on coronavirus
If you would like to submit a research file concerning COVID-19 research, and you feel that fast-track assessment is necessary, please announce this (if possible a few days in advance) by e-mail and substantiate why an accelerated procedure should be applied. Please indicate what type of study is involved (for example: drug study or not, what phase, interventional/observational, etc.). Please state in the subject line 'urgent question/file in connection with COVID-19'. The committee will then consider whether fast track submission is necessary and possible. For fast track review by the appropriate body, please send a message to firstname.lastname@example.org or email@example.com stating FAST TRACK COVID-19.
Submitters of studies with unregistered COVID vaccines and multinational studies with therapeutic drugs for the treatment of COVID submitted through CTIS may contact CCMO at firstname.lastname@example.org to discuss opportunities for expedited review (fast-track procedure).
Notification of temporary suspension of research
Please use the template for notifying suspension of research. See the CCMO site when this is applicable. For UMC Utrecht researchers, adjusted rules apply, see information on Connect.
Instructions uitklapper, klik om te openen
Please also check the websites of the CCMO and the Dutch Health and Youth Care Inspectorate (IGJ) for instructions
European guideline (EMA) uitklapper, klik om te openen
European guideline (EMA) for the performance of clinical research during the coronavirus crisis
Participating institutions: UMC Utrecht, Prinses Máxima Center for pediatric oncology and Antoni van Leeuwenhoek