Availability ToetsingOnline
ToetsingOnline will be available until 24 January 2025, 17:00 hr. Subsequently the migration to the Research Portal will be initiated. The Research Portal will be available from 3 February 2025. In the intervening period it will not be possible to submit any studies to the portals. However, it will be possible to submit study documents of previously […]
Meeting dates 2025
The meeting dates of the METc UMCG can be found here.
Review fee decree research files
The Board of Directors of the UMCG established the fees for reviewing research for METc UMCG on October 22, 2024. These fees shall apply with effect from January 1, 2025. For an overview of the new fees for reviewing research, see Table 1. Table 1. Fee for reviewing research METc UMCG Type of assessment Commercial […]
ToetsingOnline becomes Research Portal (update 11-11-24)
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. More information on Research Portal can be found in this flyer. The CCMO is organising […]
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.
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 […]
Clinical Trial Regulation expected to apply from 31 January 2022
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to go live from 31st of January 2022. See the original news item on the website of the CCMO: link
CCMO will be the competent authority for clinical investigations with medical devices
Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that from then on, CCMO will take over the tasks of the Health and Youth Care Inspectorate (IGJ) for processing the notification of these investigations. See the original item on the website of the CCMO: link
New template Subject Information Sheet is mandatory from November 2020.
The CCMO has published a new template Subject Information Sheet for research subjects of 16 years and older (adults). Researchers are encouraged to use this new template. The template will be used as criterion for the review of the submitted written information for participants. This means that both the structure of the information as well […]