CTIS application

In February, our Danish partners at the Steno Diabetes Center in Copenhagen completed the Clinical Trial Information System (CTIS) application at the European Medicine Agency in a joint effort with colleagues at the University Clinic Hamburg-Eppendorf,  INCLIVA Valencia, University of Bologna, Luigi Vanvitelli University (Campania) and Lund University.

This application is a mandatory step to obtain approval from national competent authorities and ethics committees to run the PRIME-CKD trial. A lot of respect for the team as it took 4 months to collect over 150 documents that needed to be uploaded for the application!

And now we are crossing our fingers for a positive evaluation. If it passes validation, the application will continue to the assessment phase (scientific review of the protocol and evaluation of all the documents). If all proceeds according to plan the ethics approval will be received by mid-June.