News overview

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