Data Monitoring Board (DMB)
ICH
ADVERSE EVENTS, THORACIC, RECRUITMENT, COMPLICATIONS
In case of any irregularities, for example, concerning the prevalence or type of adverse events or serious adverse events reported to the principal investigator, the members of the independent DMB will be informed without any delay. The independent DMB will receive regular reports about major complications after 20 and 40 patients have been randomized. The results of the risk and safety analysis will be reported to the principal investigator, including recommendations concerning the continuation or termination of the trial.Monitoring will be conducted according to approved standard operating procedures, which include personal site visits with verification of source data. Clinical monitoring in the RESPECT study will be performed according to the International Conference of Harmonization (ICH) Good Clinical Practice (GCP) guidelines by the Study Center of the Department of Visceral, Thoracic, and Vascular Surgery of the University Hospital and Medical Faculty Carl Gustav Carus, Dresden. The monitoring procedures are predefined in a study-specific monitoring manual and adapted to the study-specific risks for the patients. Regular on-site monitoring visits are planned at all sites depending on the recruitment rate and quality of the data (approximately one visit per site and year). The investigator must allow the monitor to look at all essential documents and must always provide support to the monitor. Study progress, recruitment, and data capture will also be reviewed at the leading centre by the principal investigator and study coordinators.The role of the Steering Committee is to provide overall oversight of the trial and ensure that it is conducted according to the rigorous standards as outlined in the Guidelines for Good Clinical Practice.