Data management and monitoring

During the evaluation period, the evaluators will complete the CRF as per the workbook. All CRFs will be dated and signed by the responsible investigator or one of the authorised staff members responsible for the quality and accuracy of the data collection process. The two research assistants will then enter the raw data into an Excel spreadsheet in double entry. During double data entry, a third person can be consulted to ensure data accuracy if there are inconsistent results.

In addition, an independent data and safety monitoring committee (DSMC) will be established to monitor trial safety. An independent DSMC comprises members who specialise in clinical physicians, statistics and ethics. The DSMC monitors the entire trial process, including participant recruitment, intervention safety, AE reporting, trial results, and data accuracy and completeness. The project manager will have access to the data, and all data will be treated with the utmost confidentiality and anonymity to anyone outside the study.

The Affiliated Rehabilitation Hospital of FJTCM and its ethics committee will make protocol decisions and communicate important protocol modifications. In addition, the project manager will coordinate the work of all departments (eg, trial registration, researcher training, informed consent from participants and data management). The project manager will notify the relevant parties at the coordination meeting if significant protocol modifications occur.