GDPR questionnaire - EC Research

CTC GDPR questionnaire

The GDPR questionnaire must be completed for every study or research project for which UZ/KU Leuven acts as sponsor or participating site and in which personal data are processed.

To facilitate the contract review by the CTC's legal department and enable the privacy review by the EC, please complete the GDPR questionnaire as soon as possible after the S-number has been assigned. A completed questionnaire is an admissibility requirement to submit your case to the EC Research. EC does not automatically receive this questionnaire. Please provide us with the GDPR questionnaire in PDF  format.

Please also note that an existing GDPR questionnaire cannot be amended in the system. A new questionnaire needs to be completed.

If you wish to submit an amendment to the EC for a study for which a GDPR questionnaire has not yet been completed because it was not required at that time ("pre-GDPR": rule of thumb, this relates to studies with an S-number created before "S63291"), please change the GDPR aspect of the study by submitting the GDPR questionnaire to EC (and, if applicable, an amended ICF with the correct GDPR wording) with the next amendment to that study.

PRET-questionnaire (KU Leuven)

The Privacy and Ethics unit (PRET)  is aimed at every investigator within  KU Leuven and established a clear flow that facilitates a correct application of the regulations. This unit will assess - based on the questionnaire that the investigator is obliged to complete - whether the research is GDPR compliant.

KU Leuven groups the GDPR and Ethics Review requests together in one questionnaire which is available at

The EC asks to provide the "accepted" questionnaire when submitting the file. Only when the PRET questionnaire has "accepted" status, can the file be declared admissible.

No involvement UZ/KU Leuven

If your study was not submitted through CTC and is not being conducted within UZ/KU Leuven, we request confirmation from the sponsor that it undertakes to respect the conditions of the General Data Protection Regulation and the Belgian Protection of Privacy Act.

Last edit: 25 April 2024