How to submit
How to submit
If UMC Utrecht is the sponsor, the investigator will be required to have the MREC Utrecht review the research (UMC Utrecht policy), except where it concerns research which must be reviewed by the CCMO.
All communication will run via the principal investigator and/or the contact person at UMC Utrecht. They can consult the Quality Coordinator of their division for the right procedure.
NOTE: Due to the coronavirus outbreak, files can only be submitted digitally at the moment. See below under “Digital submission”.
PDF's codes and file names uitklapper, klik om te openen
All documents must be submitted digitally in PDF format. Other file types must be converted to PDF. The file name of each PDF file must consist of a code (a letter and a number) plus the title of the document in question. On the right-hand side you will find a downloadable list of codes and title examples. This list is based on the list on the CCMO website and the CCMO’s standard research file, and some extra information has been added.
In addition, you should always add the date of the document and, if applicable, a version number to the file name.
Password-protected PDF documents cannot be processed (even if the password is provided).
Submitting a new study uitklapper, klik om te openen
In case of primary submission of a study for review under the WMO, you are required to submit a signed cover letter based on the relevant template; this must be a paper version. The reason for this is that it concerns applications as defined by the Dutch General Administrative Law Act (Awb) and that for the application to be lawful a so-called ‘wet signature’ is required.
You must scan the signed cover letter in PDF format. Please follow the instructions above for the correct file names (under ‘PDFs, codes and file names’). You can then send the files to our e-mail address via e-mail or via the internet (data transfer). You can put them in a single folder or ZIP file, but please do not create any subfolders. The “secure transmission” option via Zorgmail cannot be used for the e-mail address firstname.lastname@example.org, but it can be used for the e-mail address email@example.com.
NOTE: Due to the coronavirus pandemic, the original signed (paper) version of the cover letter does not need to be sent by physical post.
To guarantee the security of your documents, we advise you to choose a secure data transfer method. When sending documents using a medium of your choice, the risk will always be yours.
To ensure that applications can be processed smoothly, we cannot accept any data transfer where the receiving party must create an account and/or password. Downloading via a link is acceptable, though.
The service of SURFfilesender, which involves encryption, is considered secure for employees of educational and research institutions registered with it.
NOTE: Due to the coronavirus pandemic, new research files must be submitted entirely digitally for the time being. (See news item).
Via e-mail: Other submissions uitklapper, klik om te openen
You can send other submissions via e-mail to firstname.lastname@example.org if the size of the attachments allows it.
Attachments must always be submitted in PDF format with the right file names. Submission of password-protected PDF files or other files is not permitted, even if the password is provided separately. You can also submit annual safety reports via the ToetsingOnline portal. When submitting documents, please note the following:
- NL number, MREC number and submission type: State the NL number, the MREC number and the type of submission in the e-mail’s subject line.
- Size of documents / multiple e-mail messages: If you have to send several e-mails due to the size of the documents, please keep the subjects of the e-mails identical and add the sequence number of each e-mail and the total number of messages, e.g. 1 of 3 messages. If an individual PDF file is too big to be sent in a single e-mail, you must submit the full submission package by using data transfer, such as via SURFfilesender.
- Signature: When you submit response letters or amendments, the cover letter needs to be signed but a wet signature is not required.
The following items, among others, can be submitted via e-mail with PDF attachments:
- Response to questions
- Report on date of inclusion of first subject (=start date)
- Annual progress report
- Safety notifications and (periodic) safety reports
- Report on date of final subject’s final study procedure (=end date)
- Final results (publications, summaries, final report)
- Assessment of applicability of the WMO
Submitting safety reports via ToetsingOnline uitklapper, klik om te openen
- Submission of SAEs to the reviewing committee (METC and CCMO) is done via ToetsingOnline. This obligation does not apply to SUSARs. For more information, please see the website of the CCMO.
- Submission of SAEs for studies subject to art 82 MDR is also be done by using the SAE report form on ToetsingOnline. The reporting of SAE's for studies subject to art 62/74.2 MDR and art 74.1 MDR is done by using the 'MDCG 2020-10/2 table' on ToetsingOnline. This form is also applicable for studies subject to art 62/74.2 MDR for reporting medical device deficiencies. For more information and the format, see the CCMO website.
Timelines uitklapper, klik om te openen
The term within which the MREC must decide on your application will be stated in the ToetsingOnline portal. Via ToetsingOnline you can also keep track of the duration of the remaining decision period.
To ensure that the review process runs as smoothly as possible, the investigator will have 1 month to respond to questions and comments raised by the committee. If you are unable to submit your response within this 1-month period, you can request an extension via e-mail. Please state the reason for the delay.
If you have any questions about the procedure or the timelines, you can contact the Research Review Department via email@example.com
Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology