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

Notice board with yellow sticky note and lightbulb drawing.

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 […]

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 […]