Data collection and management
ADVERSE EVENTS, EVENT, RECRUITMENT
Data will be collected using an electronic clinical research form (eCRF) system approved by the steering committee. Each study site is responsible for data entry, and the principal investigator is responsible for confirming the final data. During the study period, a monitoring team from the contract research organization (CRO) will regularly contact and visit all sites, with occasional visits as necessary. To ensure that the study is conducted according to the protocol, the completeness, consistency, and accuracy of the data entered in the eCRF will be evaluated at each visit of the CRO. All adverse events are graded according to CTCAE v5.0 and recorded in the eCRF. The investigators are responsible for evaluating the causal relationship between protocol treatments and each event. Furthermore, they will report severe adverse events to both their institutional review board and the principal investigator. The independent Data and Safety Monitoring Board (DSMB) will monitor the recruitment, reported adverse events, and data quality when 10% (36), 30% (109), 50% (182), 70% (255), and 100% (364) of the participants are enrolled. The goal is to ensure that the study conforms to the current standards of Good Clinical Practice, with focus on the safety interests of the patients. The DSMB will provide the principal investigator with recommendations regarding potential trial modification, continuation, or premature termination.