GDPR – General Data Protection Regulation and clinical trials

Communication notifying clinical trial sponsors that SÚKL will not assess or approve consents with ensuring personal data protection  

With regard to the General Data Protection Regulation (hereinafter referred to as the “GDPR”), sponsors/applicants for clinical trial authorisation/notification are kindly requested not to submit consents with the hand-over of personal data to SÚKL. Furthermore, it is requested that such consent be in the form a separate document to be submitted to trial subjects and approved by the ethics committee.

The sponsor should submit to the ethics committee a separate consent document for personal data provision in compliance with the GDPR together with a declaration stating that personal data protection as required by the GDPR shall be safeguarded during data hand-over. The approval of the document by the ethics committee shall refer solely to the clarity of the text for trial subjects, rather than compliance with the GDPR – this is the responsibility of the sponsor.


8th December 2017

Department of Clinical Trials