Method of submission
Method of submission
The MREC NedMec reviews applications from researchers in the affiliated institutions as well as from various other researchers and (government) institutions in the health care sector. All communication goes through the principal investigator and/or the contact person of the study concerned.
For investigators from affiliated institutions, a study can only be submitted to the MREC NedMec if the local requirements of the institution where the study will be conducted are met. For more information on the specific procedure of your institution please consult the pages below:
PDF and coding file name uitklapper, klik om te openen
All documents must be submitted digitally in PDF format. The file name of each PDF document should consist of a code (letter and number) and the name associated with the document concerned. Below you will find an overview of the codes and naming examples as a download. This document is supplemented and derived from the overview on the CCMO website and the CCMO standard research file.
Always complete the file name with the date of the document and if applicable a version number.
PDF documents that are secured cannot be processed (even if the password is provided).
Submit new study uitklapper, klik om te openen
NOTE: Due to the coronavirus pandemic, the original signed (paper) version of the cover letter does not need to be sent by physical post. Please visit the CCMO website for more information.
In the primary submission of a study for review under the WMO it is mandatory to provide a signed Template Cover Letter on paper. Reason for this is that these are applications in the sense of the General Administrative Law Act (Awb) and for a legally valid application a so-called 'wet' signature on paper is required.
Please use the correct cover/response letter template.
Scan the signed cover letter as a PDF. Follow the instructions above for the correct file names (PDF and coding file name). You can then send the files by email or via the internet (data transfer) to our email address. They may be in one folder/zip file if necessary, but do not create subfolders. At the e-mail address email@example.com, the option "secure sending" via zorgmail can be used.
For the security of your documents, it is recommended that you choose a secure method of data transmission. Sending documents via your chosen medium is always at your own responsibility.
In order to keep application processing workable, we cannot accept data transfers that require an account and/or password to be created by the recipient. Downloading via a link is fine, however.
The SURFfilesender service in which you opt for encryption is considered secure for employees of (academic) institutions that are affiliated with it.
Other submissions uitklapper, klik om te openen
Attachments should always be submitted in PDF format with the correct file name. It is not allowed to submit secured (PDF) files, even if the password is given separately. Annual safety reports may also be submitted via ToetsingOnline.
Please note the following when submitting:
Indicate the NL number and type of submission (primary submission, substantial amendment, etc.) in the subject of the e-mail.
- Multiple emails
If you need to send multiple emails due to the size of the documents, please keep the subject of the emails identical and include a sequence number of the email and the total number of emails, e.g. 1 of 3 emails. If a separate PDF document is larger than will fit in one email, then you must submit the entire submission package using data transfer, for example via SURFfilesender.
For responses and amendments, the cover letter must be signed, but it does not have to be with a wet signature.
Items that can be submitted by email with PDF attachments include the following:
- Notification date 1st inclusion of a trial subject (=start date)
- Annual progress report
- Safety notifications and (periodical) safety reports
- Notification date last study treatment of last subject (=end date)
- Final results (publications, summaries, final report)
- Assessment of the WMO obligation
Submission of safety reports via ToetsingOnline uitklapper, klik om te openen
- Reporting of SAEs to the reviewing committee (MREC and CCMO) is done via ToetsingOnline. This obligation does not apply to SUSARs. For more information see the website of the CCMO.
- SAEs in studies that fall under article 82 MDR can also be reported by uploading the SAE report form in ToetsingOnline. A special format is available for reporting SAEs for studies that fall under art. 62/74.2 MDR and art. 74.1 MDR: 'MDCG 2020-10/2 safety report form'. For studies that fall under art. 62/74.2 MDR this form should also be used for reporting defects of the medical device. For more information and the format see the website of the CCMO.
Timeline uitklapper, klik om te openen
The time within which the MREC must make a decision on your application is recorded in ToetsingOnline. You can also use ToetsingOnline to follow the remaining time of the decision period.
To ensure that the review process runs as smoothly as possible, the investigator has one month in which to respond to the committee's questions and comments. If it is not possible to have the response ready within this month, you can ask for an extension by e-mail. Please state the reason for the delay.
If you have any questions about the procedure or the timelines please contact the secretariat of MREC NedMec.
Participating institutions: UMC Utrecht, Prinses Máxima Center for pediatric oncology and Antoni van Leeuwenhoek