Registration and validation study at Clinical Trial Center (CTC)
Any file you submit to EC research must first be registered with the clinical trial center (CTC). After registration at the CTC, your file is given an S-number. There are some exceptions to this.
Electronic registration with CTC required
Any file you submit to EC research must first be registered with the clinical trial center (CTC). Some exceptions are described below.
After registration with the CTC, your file is given an S number.
The S-number is a unique reference number within UZ Leuven that you can use in all correspondence with the CTC and with EC Research.
You can find more information about electronic registration on the CTC website. We also refer more specifically to this website on which the flow for the start-up of a clinical study is clarified: https://gbiomed.kuleuven.be/english/ctc/intern/study-start-up/Trial-start-up, and to the image below which visually illustrates the flow.
EC Research can only declare a file admissible if the study has been validated by the CTC.
Exception
Studies in which UZ Leuven/KU Leuven is in no way involved (as a research center), but submitted to us for advice within the framework of the Law of 7/5/2004, do not need to be reported to the CTC and may be submitted directly to EC.
This possibly concerns studies at one or more sites, none of which is linked to a fully accredited EC, and which - as provided for by the above-mentioned law - must be submitted for approval to a (university) fully accredited Ethics Committee.
Like the other files, these files also receive a unique S number, in this case assigned by EC.