Confidentiality {27}
The data protection concept stipulates that patients are only included in the study after they have been informed and after having signed the informed consent form (ICF). They will be informed as to the strict confidentiality of their data, but that their medical records may be reviewed for trial purposes by authorised individuals other than their treating physician. It is the responsibility of the investigator to maintain patients’ confidentiality. During the trial, patients will be identified solely by means of their individual identification code, and participating patients’ data will be recorded only in pseudonymised form. Trial-specific documents will be stored in accordance with local data protection law/ICH-GCP guidelines and will be handled in the strictest confidence. For the protection of these data, organisational procedures are implemented to prevent the distribution of data to unauthorised persons. Each trial site will maintain a personal subject identification list (screening numbers with the corresponding subject names) to enable records to be identified. The patients’ data will be transferred in a pseudonymised form from the trial centre to cooperating partners (coordinating investigator, data management). Names and all confidential data of participating patients will be handled in line with the obligations of medical secrecy, the European General Data Protection Regulation GDPR (Datenschutzgrundverordnung, DSGVO), the Federal Data Protection Act (Bundesdatenschutzgesetz) and the state Data Protection Act (Landesdatenschutzgesetz). Third parties have no access to original documents. After completion of the trial, data collected during the study will be kept on file for 10 years. It is guaranteed that the data protection provisions are followed.