Data associated with this study will be collected in the standardised case report form (CRF) for the outcome analysis, and a specific supervisor will be responsible for reviewing the integrity, accuracy, and consistency of the data. To ensure the accuracy of data entry, two researchers will be responsible for entering the data independently and data query forms (DQF) will be resolved by tracing the source data. All the data will be registered in document clouds, and only authorised researchers will have access. Data monitoring committee consists of the Department of Biomedical Statistics, Southern Medical University, independent from the sponsor and competing interests.
As for the audition of this study, the frequency is once a year. During the audition, the project organisation will review the test process and make a comprehensive evaluation. The process will be independent of investigators and the sponsor.
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