Data management
CSIS
ADVERSE EVENTS, RECURRENCE
When the current trial is ongoing, its data will be accessed by the Data Safety and Monitoring Committee (SMC) and Statisticians of TBCC-ARO. The principal investigator has full responsibility for the assessment of clinical data, which will be available for the principal investigator and co-investigators, if the clinical trial is finished. Clinical data, including name, contract information, subject number, informed consent, pertinent medical history, result of key parameters of trials, adverse events, recurrence, and clinical outcomes of participants, will be sent to the CSIS website of the TBCC-ARO trial, and these data and documents will be stored for 10 years after trial completion or according to the regulatory requirements.