应用REDCap系统于临床研究的随访过程管理

Application of REDCap system in clinical study follow-up process management

目的总结北京大学临床研究所临床研究项目管理经验,提出应用REDCap(Research Electronic Data Capture)数据管理系统提高随访过程管理水平.方法分析临床研究随访过程管理现状,提出应用REDCap随访管理的方法.结果REDCap通过“直接管理”和“系统管理”的数据管理方式能提高临床研究随访质量和管理水平,在此期间也能更好地保护受试者的隐私和权益.结论REDCap在源头上保证了随访过程的数据质量,并能及时跟踪和规范地进行随访管理,其可作为临床研究随访管理的辅助工具进行推广.

Objective To summarize the experiences of clinical study project management in Peking University Clinical Research Institute,REDCap(Research Electronic Data Capture)data management system was proposed to improve the followup process management.Methods Current clinical study follow-up process management situation were analyzed and methods for utilizing REDCap in follow-up management was proposed.Results Using REDCap through"direct management"and"system management"data management can improve the follow-up quality and standard level of management in clinical study,at the same time,secured better protection of participants^privacy and rights during the process.Conclusions REDCap plays crucial roles in securing follow-up data quality from the source,timely tracking and standardization of follow-up management,it can be adopted more widely in assisting clinical study follow-up management.