Data management
Data is collected using the secure online Electronic Data Capture application Castor (Castor EDC). The source data is found in the Electronic Health Record of each respective center. Names of patients and their patient number will be replaced by a computer-generated study code for all study related procedures. A separate file with patient number and specific code will be produced for the biobank. Outcome variables will be analyzed by physicians within the Sponsor’s institute who are not directly involved in the conduct of the study.