临床试验早期介入式数据管理模式探讨

Explore of data management model of early intervention in clinical trials

目的:探讨解决临床试验实时监控问题的途径。方法:该法与传统的临床试验管理模式完全兼容,方便快捷,更凸显了整个临床试验过程中数据管理的重要性。受试者正式入组前数据管理方即根据临床试验研究方案将CRF整理成Excel格式的e-CRF,并在Excel中利用系统自带的VBA语言编写相应的核查程序。数据管理方即时通过对e-CRF的核查、分析和处理来加强对临床试验的实时监控,完善临床试验的过程管理。结果:本方法极大地提高了临床试验研究的效能,提高数据质量、缩短研究周期、警戒潜在的风险、减少脱落、节约成本等。结论:早期介入式数据管理模式在国内大部分临床试验机构现有的基础设施和条件下将大有可为。

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.