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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.

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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).

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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.

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More documents and templates uitklapper, klik om te openen

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

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