Bron: CCMO LinkedIn pagina 31 januari 2023
After a one-year transition period, from today, all initial clinical trial applications in the EU will be submitted via CTIS.
The Clinical Trials Coordination and Advisory Group (CTAG) published a “Quick guide on the rules and procedures of the EU Clinical Trials Regulation”: Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU | European Medicines Agency (europa.eu)
A useful guide for sponsors and investigators, to quickly get acquainted with the CTR.