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.

Use of the Addendum MREC NedMec (in combination with the CCMO standard cover letter) is mandatory for primary reviews.

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.

Model documents uitklapper, klik om te openen

A1. Cover letter

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.

B6. MREC form Notification end of study

To report the termination or premature termination of a study in the Netherlands you can use the MREC form Notification end of study.

M1. Progress report

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.

Research file and institution-specific documents uitklapper, klik om te openen

CCMO standard research file

Antoni van Leeuwenhoek

Princess Máxima Center

UMC Utrecht

Participating institutions: UMC Utrecht, Prinses Máxima Center for pediatric oncology and Antoni van Leeuwenhoek

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