Submitting to the reviewing committee

The information as stated below only concerns submission to the reviewing committee. In case of research with a medicinal product you also need to submit your research file to the competent authority. For more information see Research with a medicinal product & extra review competent authority and During and after the research & the competent authority .

In general: submitting to an MREC or the CCMO

If you have any queries concerning the permitted form of the submission (paper, digital) to the reviewing committee, please contact the MREC carrying out the review.

Correct coding and titles are important for efficient processing of your submission. Use the list Coding and examples of document titles for digital submission. The document title should start with the two characters (letter + number) of the regarding documents in the standard research file. You are also required to give the version and date in the title. If you do not then there is the risk that the competent authority will view your submission as invalid and will return it, causing unnecessary delay of the processing of your request for review.

The competent authority checks whether the research file is complete in accordance with the standard research file therefore it is important you adhere to this classification.

In the case of a primary submission it is required to submit a signed hard copy cover letter. This is necessary as a primary submission is a request in the sense of the General Administrative Law Act (Abw) for which a signed hard copy letter is the only legally valid form.

Specific: submitting to the CCMO

If the CCMO is the reviewing committee then the preferred method of submission for all documents concerning the primary submission is digitally on cd-rom. Only the cover letter has to be submitted as hard copy as proof of signature. The signatures in other signed documents on the cd-rom may be inserted or a scan of the originally signed document. You may also submit your file as one single hard copy (unbound). ToetsingOnline is currently being developed to support submission of a complete digital research file, however this functionality has yet to be finalised.

The address of the CCMO is:

Central Committee on Research Involving Human Subjects
F.a.o. the reviewing committee
PO Box 16302
2500 BH The Hague
the Netherlands

You are required to submit all digital documents in pdf format. Please save all files separately onto cd-rom (not in folders) and do not use zip files. It is not permitted to submit pdf files that are encrypted, even if the password is provided.