Plans for assessment and collection of outcomes {18a}
All patient data will be kept according to the GDPR and the Data Protection Act. Acceptance of the data handling and management will be applied for these institutions before the initiation of the study. The patient data will be kept in an encrypted electronic database, REDCap, and handled as continuous records. The responsibility for the data in the electronic database (eCRF) in REDCap is of the principal investigator. All data will be entered concurrently with the study enrollment by study personnel, and all data will be stored pseudo-anonymously for 25 years. Monitoring of the study will be done by a local GCP unit. The trial will be conducted in compliance with the published trial protocol, the Helsinki Declaration, the GCP guidelines (ICH-GCP), and European and national laws. The first monitoring meeting will be held after inclusion of 2 patients. The following meetings will be held as needed. A full monitoring plan will be elaborated and composed before the initiation of the study by the local GCP unit.