Reporting of clinical trials with centers located in the EU
Multicenter clinical trials with medicinal products that maintain study centers located within the EU must be registered in the European Clinical Trial Information System (CTIS) as of 31 January 2022. This is a consequence of the entry into force of the new Clinical Trial Regulation (CTR).
Studies at the USB
CTIS is a portal for submission, approval and management of clinical trials. It consists of two sections for sponsors and authorities, as well as a public website intended as information portal. The University Hospital Basel (USB) is registered in CTIS as official organisation. Studies for which the USB serves as sponsor can be easily recorded via this access. The Department of Clinical Research (DKF) has administrator rights and can assist researchers to obtain access and enter their studies.
There is a transition period for the move to CTIS. Until January 31, 2023, studies can be entered in CTIS or the previous system. After that, entry via CTIS will become mandatory. By the end of 2025, all studies either must have been completed or transferred to CTIS.