Here you will find the frequently asked questions, grouped together in specific topics. If your question is not listed, please contact the METc-bureau and we will try to answer your question.
Here you will find the frequently asked questions, grouped together in specific topics. If your question is not listed, please contact the METc-bureau and we will try to answer your question.
Research proposals must meet the following technical requirements:
HINT:
Please make sure the version/date in the document matches the file name. The version/date in the document is leading for the registration.
For an overview of which documents to submit for WMO research, please see our ‘Submission, WMO applicable’ page.
The submitted documents are first screened for completeness and accuracy and then registered in our system. Screening and registration takes up to 2 or 3 working days. After screening and registration a confirmation of receipt is sent to the applicant’s postal address.
You may submit the response by CD Rom or USB drive, accompanied by a (paper) cover letter:
This can be sent to the postal address of the METc secretariat.
You may submit the proposed amendment by CD Rom or USB drive, accompanied by a (paper) cover letter:
No, you do not have to request a declaration by the METc UMCG that the research doesn’t fall within the scope of the WMO. You already have such a decision by another accredited committee. The accredited committees in the Netherlands have agreed that one decision on whether or not a research falls within the scope of the WMO is sufficient.
However, some centres require a certain ‘due-diligence’ review before the execution of the research in their institution.
Please see our Non WMO page for more information.
In the UMCG, nWMO research needs to be registered in PaNaMa and assessed, as described in the Research Code.
A nWMO study can also be registered in the Research Portal for registration in the OMON (Overview of Medical Research in the Netherlands, formerly the National Trial Register). This is separate from the procedure at the UMCG.
New applications are put on the agenda on a ‘first come, first serve’ basis. At least 1 meeting per month is dedicated to research with a medicinal product. This is taken into account when tabling the research proposal.
NOTE:
If you want to assure a place for your research proposal on the agenda, please submit the application at least 2 weeks before the meeting date you’re aiming for.
There is a maximum of 6 new research proposals per meeting.
In case your proposal is the 7th on the agenda, your proposal will be rescheduled for the next meeting thereafter.
The application will not be discussed nor will it be put on an agenda if the submission package is inaccurate ornot complete ,. The applicant will be requested to amend the omission.
Applications for review are processed and reviewed when the submission package is complete, accurate and relevant documents are signed.
The applicant will receive a confirmation of receipt as soon as possible, generally within 2 to3 weeks. This will take place after screening for completeness and accuracy, and registration of the documentation.
Depending on the decision of the METc during the first meeting, the rebuttal and attached documents are:
Generally, it takes 2/3 weeks to formulate a final decision and send it to the applicant.
Please see our Submission, WMO page for more information.
Generally, within 2 weeks the applicant will be notified of the decision of the METc.
You can find our template Progress Report on our Documents page.
Applicants can report the SAEs through ToetsingOnline. The METc receives a notification of a new report. The decision on the report is filed in ToetsingOnline.
Via our Contact & Information page or the website of the CCMO a current overview of the members of the METc UMCG is available.
No, the decision of the METc is made on behalf of all the committee members and we ensure that the legally required disciplines are represented during the meeting. This way, we adhere to the stipulations for an accredited ethics committee, as described in the WMO, and do not feel it’s necessary to enclose a list of members who were present during the meeting and, in doing so, to specify who represented the required discipline.
No, the Board of Directors of the UMCG doesn’t send a separate approval letter when the METc UMCG gives a favourable opinion on the execution of the medical-scientific research in the UMCG. The Board of Directors will only give a separate approval when another accredited ethics committee has given a positive decision. (This in light of the local approval as meant in the CCMO External Review Directive.) You can find more information on this subject on our Submission page.
All the medical scientific research that is conducted in the UMCG or where the METc UMCG acts as reviewing committee, must be entered in the UMCG Research Registry.
Only substantial amendments must be submitted for approval to the METc UMCG. The sponsor decides when an amendment meets those criteria. Generally, an amendment is considered ‘substantial’ when the proposed revision have significant impact on:
No, according to the NFU document titled “Kwaliteitsborging mensgebonden onderzoek 2.0” the independent expert doesn’t have to have a valid BROK certificate. After all, this person is not directly involved in the clinical trial. Persons that are directly involved in the clinical trail, such as the principal or coordinating investigator, must have a BROK certificate.