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
cz