Personal Data Protection
The controller of personal data, who determines the purposes and means of processing within the project, is ČNS. The patient can´t be included to the project without signed explicit informed consent. For the acquirement and storage of patient informed consent for statistical and scientific purposes is responsible investigator/Provider of health services (centre) according to conditions stated in the contract. The exact purposes are described in the informed consent form, which is appendix No. 2 of this document. The information, the patient has given consent with processing of his/her data should be confirmed at EDC system for data collecting. Without this confirmation, new patients can´t be added.
The processors of personal data in the register are investigators/health care facility (centre) and IBA. The physician enters the patient data into the register under the numerical code. The following personal data are processed within the project based on patient explicit informed consent: first and last name, date of birth, gender, initials, zip code, county of residence, telephone number, email address and medical condition including medical history and evaluation, as well as a unique numerical code (ID) assigned to the individual patient.
The patient can exercise her/his rights with the physician or directly with the controller. The contact details are listed in the ICF. The physician shall be familiarized with rules for personal data processing in the form of binding standard procedure provided by controller acting through IBA.
The patients are informed about handover of their personal data to IBA before granting explicit informed consent. IBA is obliged to accept the suitable technical and organisational measures.