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Frequently Asked Questions (FAQ)

Frequently Asked Questions (FAQ)

Below you will find a list of frequently asked questions. Did you not fid the answer to your question? Then contact us via info@metcutrecht.nl or +31 (0)88 75 56 376. We will be happy to help you.

What is the review status of my WMO research file or amendment?

You can check the status of the review of your file via ToetsingOnline. Via ToetsingOnline you can also download decisions and further decisions by the committee.

Should I submit my change as a substantial amendment or as a minor change? 

Minor changes, such as textual corrections, are generally only acknowledged by the review committee (MREC or CCMO). More substantial modifications, such as the addition of a new participating centre, require a further decision. This also applies to modifications that can affect the safety of the human subjects. These are considered substantial amendments.

For more information, go to: 'CCMO Amendments'

For submission instructions, go to: How to submit

Is my change an amendment to a research file reviewed previously, or is it a new study? 

Generally, the following applies: If a change is within the scope of the primary research question of the study, it will concern an amendment. If it is beyond the scope of the primary research question, it will concern a new study.

Should I submit the English translation of the subject information sheet as an amendment?

The MREC reviews the Dutch subject information sheet. The Sponsor is responsible for translation of the subject information sheet. All subject information sheets must be identical to the approved version. This means that the translation must be accurate. We advise you to engage a sworn translator for this.

The investigator and/or the sponsor may decide, possibly in consultation with a Quality Coordinator or other responsible person, that the accuracy of the translation has been sufficiently assured. In that case, please describe the approach used in a ‘Note to File’.

Can I obtain an English translation of a WMO decision or of the MREC’s advice on non-applicability of the WMO?

Please refer to the English-language section in the decision letter. If this is not enough, we advise you to engage a sworn translator.

Will my research be considered research with a medical device?

Please consult the CCMO website for information on research with a medical device until 26 May 2021. There you will find, among other things, the definition of medical devices according to the Medical Devices Act, legal frameworks, information on review by a recognised MREC, and registration with the Health and Youth Care Inspectorate (IGJ)

Useful links:
-     MREC news item on postponement of the European Medical Device Regulation, EU no 2017/745 (MDR)).
-     For UMC Utrecht investigators: Connect page on medical technology (Medical Technology & Clinical Physics Department)

Non-WMO research with a medical device: See the relevant explanation on the page Is review required?

Should I always submit changes to non-WMO research?

For more information on reporting changes to non-WMO studies, go to: Is review required?

How can I obtain local permission for WMO research at UMC Utrecht?

For more information on the addition of UMC Utrecht as a local participating centre, go to: UMC Utrecht as a local participating centre.

Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology

 

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