During and after the research
During the research, when the research is being completed and thereafter, the sponsor is also required to regularly submit information to the review committee and, in the case of research with a medicinal product, to the competent authority.
The sponsor is required to report the following to the reviewing committee (MREC or CCMO) both during and after the study:
- Starting date
- Changes to the research file (amendments)
- SAEs, SUSARs, SADEs and line listings
- Progress report
- Development Safety Update Report (for research with a medicinal product)
- Supspension, premature termination or end of study
- Summary clinical trial results
If you have any queries concerning the allowed form of the submission (paper, digital) to the reviewing committee, please contact the MREC carrying out the review.
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 the CCMO must always be accompanied by the submission of a signed hard copy (on paper) version of the cover letter. This is required as submission of a substantial amendment is a request in the sense of the General Administrative Law Act (Abw) for which a signed hard copy cover letter is required for a legally valid request.
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 the CCMO
If the CCMO is the review committee, the preferred method of submitting all documents concerning the primary submission is digitally on cd-rom. Due to the necessary signatures only the cover letter must be submitted as hard copy. The signatures in other signed documents on the cd-rom may be inserted or a scan of the originally signed document provided.
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
You are required to submit all digital documents in pdf format. Please save all files separately onto the cd-rom (not in maps) and do not use zip files. It is not permitted to submit pdf files that are encrypted, even if the password is provided.
Only for 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, etc.) you have the option of submitting either by email (maximum 8 MB), cd-rom (by post) or Eudralink. Clearly 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: email@example.com. SAEs, line listings of SAEs and SUSARs and annual safety reports can also be submitted via ToetsingOnline.
Submissions by email (including all the necessary attachments) must be limited to one email message only: therefore, submissions larger than 8 MB may not be spread over multiple emails. If your submission is larger than 8 MB, please use a cd-rom. 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 need to be available for at least three months.
Research with a medicinal product
In case of a research with a medical product you do not only have to inform the review committee (MREC or CCMO) but also the competent authority (CCMO or the Ministry of Health, Welfare and Sport). More information: Research with a medicinal product: extra review competent authority.
Extra regulations apply to reports during and after the study for certain types of research. More information can be found at: