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 […]