Data management {19}
CRF
CRF
An independent internal monitor (Tirol Kliniken) will provide the monitoring and quality assurance of the study. The study team will process data entry from paper based CRF into statistical software. Programmed checks make data validation of range, validity, and consistency. If necessary, queries are made by the study software or an authorized person. Based on the questions, the investigator can check and clarify discrepancies.After recording all entries and clarifying all queries, the database will be closed after the study. This performance must be documented. All data will be handled confidentially, and research data will be coded using a unique patient identification number. To reproduce the study findings and help future users understand and reuse the data, all changes made to the raw data and all steps taken in the analysis will be documented. The database files will be kept for 15 years after the study has ended.