Data management
Data handling and protection are conducted according to the ISO 27001-compliant processes and ICH-GCP and applicable regulations. Confidentiality will be maintained at all times and participant information will not be disclosed to third parties. After giving informed consent, the patient will receive a unique identifier. All generated (meta)data will be stored in a secure research folder structure for access control. Only researchers directly involved in the study and the monitor of the study are allowed to access the key-linking table to enable patient re-identification. The paper data files and informed consent will be stored in a locked cabin in a locked room. Only research members directly involved in this study and the monitor of the study will get access to all of the collected research data. When required, authorized personnel of the study can access the pseudonymized source data for intermediate analysis or business intelligence reports.