During and after the research
During the study, in the completion phase of the study and thereafter, the sponsor is also required to submit information regularly to the review committee and, in the case of research with a medicinal product subject to the Dutch WMO Act, to the competent authority as well.
The sponsor is required to report the following to the review committee (MREC or CCMO) both during and after research with a medicinal product subject to the Dutch WMO Act:
Additional or different regulations for certain types of research
Additional or different regulations apply to reports during and after the study for certain types of research. More information can be found at:
- Clinical trials with medicinal products (CTR)
- Research with medical devices
- Performance studies using in vitro diagnostics (IVDR)
- Research on gene therapy/medicinal product with GMO
- Research on ATMPs: Out of specification (OOS) ATMP
How to submit research with a medicinal product subject to the Dutch WMO Act
If you have any queries concerning the submission procedure of the reviewing committee, please contact the MREC concerned.
The correct coding and titles of your documents 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 review committee 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 substantial amendment, you are also required to submit the EudraCT form notification of amendment (B5). If this form is missing then you must state the reason in the cover letter (A1). Failure to do so will result in your submission being considered incomplete and it being returned without processing. The submission of an amendment to an MREC or CCMO must always be accompanied by the submission of a cover letter.
Other submissions, such as SUSARs, an annual safety report, (DSUR or ASR), a notification of the end of the study and the clinical trial report, are not requests in the sense of the law. A signature on paper (hard copy) is not required for these submissions. A copy of the signature will suffice, by which is meant a scan of the originally signed document or a signature inserted in the digital document.
Submitting to CCMO as review committee
This applies to research with a medicinal product that is subject to the Dutch WMO Act, to other research subject to the Dutch WMO Act and to research subject to the Dutch Embryo Act, if CCMO is the reviewing committee.
If CCMO is the reviewing committee, you must send all documents to email@example.com. The signatures in the coverletter and other documents may be an insert; a scan of the originally signed document also suffices.
You are required to submit all digital documents in pdf format. Submitting password-protected files is not permitted, not even if the password is provided.
Submissions other than primary applications and substantial amendments (such as annual safety reports – DSUR or ASR – a notification of the end of the study and clinical trial reports, et cetera.) must also be submitted by email, preferably by Eudralink (maximum 8 MB). Please state the NL number from ToetsingOnline in the e-mail subject field, followed by a short description of the submission. A hard copy cover letter is not required. These documents can be mailed to: firstname.lastname@example.org. SAEs, line listings of SAEs and SUSARs and annual safety reports may also be submitted via ToetsingOnline.
Please note: Emails containing a link to Eudralink for downloading the attachments will only be accepted if neither link nor files are password-protected. If either link or files are password-protected, your submission will be refused. Eudralink submissions must be made available for a minimum of three months.