Reminder to Sponsors: One Year Left to Transfer Trial Data to EU’s CTIS
Sponsors have one more year to transfer records on any ongoing trials in Europe to the EU Clinical Trials Information System (CTIS) database.
The three-year transition period established in the EU’s new Clinical Trials Regulation will end on Jan. 31, 2025.
Sponsors of trials that are expected to run past Jan. 30, 2025, should consider the time it will take EU member states to complete trial authorizations. Although CTIS will use an accelerated transition process whenever possible, the authorization process can take up to three months, according to the European Medicines Agency (EMA).
Ongoing trials do not need to be paused or closed out while they’re transitioned to the CTIS.
The EMA is providing training courses to help sponsors with the transition.
Access the EMA’s CTIS training materials here.