Method of submission
METC NedMec+ reviews applications both from researchers at the affiliated institutions and from researchers and (government) healthcare institutions not affiliated with METC NedMec+.
All communication takes place via the principal investigator and/or the contact person for the study in question.
For researchers at the affiliated institutions, a study can only be submitted to METC NedMec+ once the local requirements of their own institution have been met. For more information about the specific procedures at your institution, please contact your institution's research office or research support department.
More information about the specific institutional policies of the institutions to which METC NedMec is affiliated can be found on the following pages:
Amsterdam UMC
Antoni van Leeuwenhoek
Princess Máxima Center
UMC Utrecht
Standard requirements
- For all study types, files must be submitted as separate PDF documents. For readability purposes, the METC asks you to submit PDF documents in OCR format (searchable version).
- Files may not be password-protected. PDF documents with security enabled cannot be processed (even if the password is provided).
- The file name of each PDF document must consist of a code (letter and number) and the name corresponding to that document. Below you can download an overview of the codes and naming examples.
- All documents must include a version number and version date in both the file name and the document itself. The same version number and version date shown in the documents must also be entered when uploading the documents in the Research Portal.
- If you submit multiple documents of the same type, the distinction between them must be indicated.
- For submissions via the Research Portal (WMO-regulated and DCRF research), this distinction must be indicated in the 'Reference' field.
Submitting a new study
For the initial submission of a study for review under the WMO, it is mandatory to provide a signed cover letter. The reason for this is that these are applications within the meaning of the General Administrative Law Act (Awb), and a legally valid application requires a so-called signature.
Submitters are advised that use of the METC NedMec+ model cover letter is mandatory. This can be downloaded from the 'Documents and forms' page on this website.
Scan the signed cover letter as a PDF. Follow the instructions above for correct file names (PDF and file name coding). You then submit the files via the Research Portal.
Please note:
The requirement for a wet-signed cover letter for initial submissions and substantial amendments has been suspended until further notice. Instead, a digital or scanned signature of the submitter is sufficient. This also applies to appeals and objections. For more information, see the CCMO website.
Answering questions (responses)
The answers to the committee's questions must be included in a separate response letter, which must be submitted via the Research Portal. This can be done under the category 'Cover letter'.
Amendments
Both substantial and non-substantial amendments must be submitted via the Research Portal under ‘Amendments’.
Submitters are advised that the submission of an amendment, whether substantial or non-substantial, must be accompanied by a signed cover letter. In this cover letter, you indicate whether the amendment is substantial or non-substantial, what changes are being proposed, and the rationale for these changes.
Use of the METC NedMec+ cover letter for amendments is mandatory. This can be downloaded from the 'Documents and forms' page on this website.
Amendments submitted as non-substantial may still be deemed substantial by the committee. You will not be informed of this in advance.
Other submissions
Other submissions, such as progress reports and serious adverse events (SAEs), must also be submitted via the Research Portal. Follow the instructions on the CCMO website for this.
Timeframe
The timeframe within which the METC must decide on your application is tracked in the Research Portal. You can also monitor the remaining duration of the decision period via the Research Portal.
If you have any questions about the procedure or the timeframes, you can contact the secretariat of METC NedMec.
Thank you for your review!