Documents & forms
Documents & forms
On this page you will find a selection of the available MREC model forms & documents that may be applicable at/after the medical ethics review.
Model documents, such as the model research protocol, the model PIF, research statement, etc., can be found on the 'Standard research file' page of the CCMO website.
More information on the submission procedure, as well as information on documents to be submitted, can be found on the page Method of submission.
Cover letter templates uitklapper, klik om te openen
For the submission of new research (WMO and MDR) you should use the standard cover letters of the CCMO and attach the completed Addendum of the MREC NedMec.
Use of the standard cover letter from the CCMO and the Addendum MREC NedMec is mandatory for all applicants.
Addendum to cover letter uitklapper, klik om te openen
Use of the Addendum MREC NedMec (in combination with the CCMO standard cover letter) is mandatory for primary reviews.
Exception: no addendum is required for the assessment of clinical trials of medicines falling within the scope of the EU Clinical Trials Regulation (CTR).
Checklist e-Consent uitklapper, klik om te openen
If electronic consent (eConsent) is to be used within a clinical study, it is mandatory to submit this completed checklist along with the research file to MREC NedMec. Submission of the Checklist is also required if the sponsor modifies an approved study to add the option for electronic consent (amendment).
MREC form 'Notification end of study' uitklapper, klik om te openen
To report the termination or premature termination of a study in the Netherlands you can use the MREC form Notification end of study. For clinical trials with investigtational medicinal products (IMP) that are still being conducted under the rules of the CTD (Clinical Trial Directive), a completed EudraCT End of Trial Form must also be submitted.
MREC form 'Progress report' uitklapper, klik om te openen
You must inform the MREC at least once a year on the progress of ongoing research. In the case of drug research the progress report may be combined with the annual safety report.
MREC form (non-)WMO uitklapper, klik om te openen
When in doubt if a study is or is not subject to the WMO, investigators can submit a (non-)WMO form to the MREC. The form can be downloaded from this page and use of this form is mandatory. Please also read the brief explanation accompanying the form.
More documents and templates uitklapper, klik om te openen
Participating institutions: UMC Utrecht, Prinses Máxima Center for pediatric oncology and Antoni van Leeuwenhoek