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.
More information on the submission procedure, as well as information on documents to be submitted, can be found on the page Method of submission.
Although METC Amsterdam UMC and METC NedMec merged to form METC NedMec+ on 1 July 2026, not all METC-specific template documents and forms have yet been harmonised and aligned.
If you were planning to submit your research to METC Amsterdam UMC or METC NedMec, please click on the drop-down menus below for the METC-specific template documents and forms that apply to your research application.
MREC Amsterdam UMC
It is compulsory to use the METC Amsterdam UMC standard cover letter for new submissions and amendments. The standard cover letter does not need to be signed.
MREC NedMec
Cover letter
When submitting new research proposals (WMO, MDR and IVDR), you must use the CCMO’s standard cover letters and attach the completed METC NedMec addendum (mandatory for all applicants). For amendments, you must use the model cover letter, which can be downloaded below.
- A1. Cover letter WMO-research
- A1. Cover letter CTR-research
- A1. Cover letter MDR-research
- A1. Cover letter IVDR-research
- A1. Cover letter for responses (NL)
- A1. Cover letter for responses (EN)
- A1. Cover letter amendment (NL)
- A1. Cover letter amendment (EN)
Addendum to the cover letter
Use of the METC NedMec Addendum (in conjunction with the CCMO standard cover letter) is mandatory for initial assessments.
Exception: no addendum is required for the assessment of clinical trials involving medicinal products falling within the scope of the EU Clinical Trials Regulation (CTR).
E-Consent Checklist
Where electronic consent is used, it is mandatory to submit this completed checklist as part of the research dossier. The checklist must also be submitted in the event of amendments, should the sponsor wish to add the option of electronic consent to a study that is already ongoing.
Non-WMO form
If you are unsure whether a proposed medical-scientific study involving human subjects falls within the scope of the WMO, you can submit a (non-)WMO form to METC NedMec+.
Please note: METC NedMec+ charges a fee for assessing whether or not a study falls within the scope of the WMO. See the ‘Fees’ page for the current rates.
Information letter for pregnant research participants (or their partners)
If, as part of the research, data is to be collected from research participants who have become pregnant whilst taking part in the research, they must be informed and give their consent before any data may be collected. The same applies to the collection of data from the partners of research participants who have become pregnant whilst the research participant was taking part in the research. To assist researchers in drafting an information letter and consent form for pregnant research participants (or their partners), a model information letter has been drawn up.
More model documents and templates
For submission to METC NedMec+, the research dossier must consist of a number of basic documents. Depending on the type of research, these basic documents can be found on the CCMO website. Please see the following links:
- CCMO Standard research file for clincal trials subjet to the Dutch WMO Act and research subject to the Dutch Embryo Act
- CCMO Standard research file for clinical trials with medicinal products (CTR)
- CCMO Standard research file for clinical trials with medical devices (MDR)
- CCMO Standard research file for performance studies using in-vitro diagnostics (IVDR)
Thank you for your review!