On 31 January 2022, the Clinical Trials Regulation (CTR) came into application, harmonising the submission, assessment and supervision processes for clinical trials in the European Union. After a one-year transition period, all trials must be submitted via the new Clinical Trials Information System (CTIS). To be well prepared for this transition and to get acquainted with the new process, we set up a CTR working group and selected a study to submit via CTIS. This first submission went very smoothly, and our study was actually the first to be approved under the CTR in The Netherlands. We are happy with this great milestone and are ready for the CTR!