Data management and quality assurance
THORACIC
Day-to-day support for the trial is provided by the principal investigator who will take supervision of the trial and the medical responsibility. All data management will be performed in the REDCaP® online database. The entered data are managed and processed by the study centre of the Department of Visceral, Thoracic, and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, the Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital and further participating centres in accordance with data protection regulations.The data are checked by range, validity, and consistency checks. The site staff is responsible for data correction. A statement must be provided for any missing data.The data manager will supervise and support the solution of data discrepancies and will close all correctly resolved discrepancies. If an outstanding entry cannot be solved, the data manager may close the entry. At the end of the study, the database will be closed after all relevant data according to the study protocol have been entered. Thereafter, any changes to the database are possible only by a joint written agreement between the coordinating investigators and the data manager.