Data governance
This study will adopt paper storage and Microsoft Excel input for preservation and analysis. Authority assignment: Data entry personnel have the authority to input, modify, and resolve questions. Investigators have specific permissions to modify, browse, resolve challenges, and review. Monitors have rights to browse, send/close challenges, freeze data, and lock. Investigators should retain all detailed original documentation of subjects to ensure that the data are accurate, complete, and timely. Original documents and medical records should be clear, detailed, and easily identifiable by those involved in the trial. Research assistants of chief investigating centre are responsible for regular study monitoring.