News overview

Practice with the Voluntary Harmonisation Procedure (VHP)

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.

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.

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.

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.

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.

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