METc UMCG takes over Isala files
Since February 1, 2024, it is no longer possible to submit a study to METc Isala. METC Isala has stopped. Researchers/sponsors of ongoing studies have now been informed.
ToetsingOnline becomes Research Portal
The CCMO is preparing for the replacement of ToetsingOnline. In early December the new Research Portal will go live. Researchers will be able to submit applications for review by the MREC via the Research Portal. See this CCMO webpage: https://english.ccmo.nl/toetsingonline/transition-to-research-portal.
Download requests external parties
The METc UMCG regularly receives requests from third parties to download files. These files are to be considered a submission of a new clinical trial or substantial amendment. The METc UMCG will delete these requests unless it is agreed upon previously. Part of this previous agreement is that a request for download is always accompanied […]
Transition to CTR
EMA has published a document to help Sponsors / Investigators with the transition of drug trials: CTIS: how to get started and how to transition a trial. The review of a transition trial in the Netherlands is free of charge. An expedited procedure is possible except in cases where questions are raised in the validation […]