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News overview

News overview

Coronavirus: Amended procedures

Due to the coronavirus outbreak, the Research Review Department has amended its procedures. Please check this page regularly for updates.

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Research with medical devices: MDR implementation postponed until 26 MAY 2021

Research with medical devices: MDR implementation postponed until 26 MAY 2021

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Practice with the Voluntary Harmonisation Procedure (VHP)

Practice with the Voluntary Harmonisation Procedure (VHP)

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Change to response time as of 1 November 2019

As of 1 November 2019, applicants submitting a research proposal will have up to 4 weeks to respond to questions received from the MREC. Until then the maximum period is 8 weeks. The new, shorter period will promote quick and efficient processing of research proposals. In addition, with the new period we are anticipating new EU legislation that will be implemented in 2020 and that will require shorter, stricter time frames.

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Change to the MREC’s meeting schedule at the end of September 2019

As of 24 September 2019, meetings of Chamber M will be held on Tuesdays instead of on Mondays (like before: in odd weeks). Meetings of Chamber D will still be held on Tuesdays in even weeks.

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Updated WMO / Non-WMO Form

A new version of the so-called WMO / Non-WMO Form is now available. The new version more specifically asks for information based on which the MREC will decide on the applicability of the WMO. Use of the new form is therefore recommended.

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BREXIT AND CLINICAL RESEARCH

At the moment we do not know when the United Kingdom (UK) will leave the European Union (EU), whether a withdrawal agreement will be reached, and whether there will be a transitional period. That’s why it is important for sponsors and investigators to be prepared for a no-deal Brexit.

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TEMPLATE SUBJECT INFORMATION FROM 1 APRIL 2019 CRITERION FOR REVIEW OF INFORMATION LETTER

The Template subject information, which helps researchers to write a concise and clear information letter for research subjects, will apply as a criterion for the review of the submitted information letter by the review committee (accredited MREC or CCMO) for newly submitted research files as from 1 April 2019. This means that from then on the template no longer has a non-committal character.

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CCMO Template for annual safety report of investigator-initiated research with a medicinal product

On request of UMC Utrecht, the CCMO has provided a template for annual safety reports of investigator-initiated research with a medicinal product

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