GDPR
The processing of personal data of individuals involved in the registry is carried out in compliance with the requirements and provisions of Act No. 101/2000 Coll., on the Protection of Personal Data and on Amendments to Certain Acts, as amended, or with any legal regulation replacing this Act, and in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (hereinafter referred to as “GDPR”).
Both the controller and the processor of personal data (PD) are obliged to comply with the rules and obligations arising from GDPR, particularly ensuring the security of PD processing by implementing adequate organizational and technical measures, as well as establishing processes for exercising data subjects' rights.
The data controller, determining the purpose and means of processing within the registry at the request of the sponsor, is the Institute of Biostatistics and Analyses, Ltd. (IBA), ID: 027 84 114, headquartered at Poštovská 68/3, 602 00 Brno, registered in the Commercial Register maintained by the Regional Court in Brno, file no. C 82448. IBA ensures the management of the registry from a project, technical, and analytical perspective.
The processing of patient PD is carried out exclusively based on a signed explicit informed consent.
The processor of patient data in the study is the investigator/healthcare provider. The physician enters the patient into the registry under a unique numerical code (ID) and is the only person who can identify the patient based on the ID.
The results achieved within the registry will be published in aggregated form for large groups of patients, ensuring full anonymity (anonymized data).