关键词: 临床试验, 数据管理, e-CRF, 实时监控, 电子数据捕获

Abstract: AIM: To explore solutions to real-time monitoring of clinical trials. METHODS: The method with the traditional clinical trial management is fully compatible and convenient; data management plays a very important role more evidently in the entire clinical trial process. Before the subjects rolling into the test, the data management side should organiz CRF into Excel format 's e-CRF based on clinical trials investigational protocol, and write the appropriate verification procedures using Excel's VBA language system. Data management side enhances real-time monitoring and improves the process management of clinical trial through verifying, analyzes and processes e-CRF. RESULTS: This method can greatly enhance the performance of clinical trials by improving data quality and shortening the research cycle period, warning of potential risks, reducing dropping, saving costs. CONCLUSION: Deta management model of early intervention will be a very promising tool under the circumstances of the existing basic instructure and conditions of most clinical trial institutions in our country.

Key words: Clinical trial, Data management, Electronic case report form, Real-time monitor, Electronic data capture