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 […]
Meeting dates 2024
The meeting dates of the METc UMCG can be found here.
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 […]