摘要
目的糖尿病风险人群筛查及早期干预多中心研究课题组参与电子数据获取系统（EDC）建设能提高数据管理的质量。方法根据临床研究设计提出合理需求，查找研究方案与EDC对接的不足，持续改进EDC系统实现方式、系统安全、数据传入与导出、质量控制等问题。结果2014年4月1日至2014年8月15日利用EDC系统进行数据管理共收集数据4030例，有效电子病例（e-CRF）3847例，无效数据183例，有效率95．45％。结论课题组参与EDC系统建设提高了数据管理和质量控制的效率。
Objective To analysis the improvement of data quality management resulted from a multi-center study research group participating in construction of the electronic data Capture system （EDC）. Methods To find out the mismatch between research proposal and EDC according to the reasonable design of clinical research, and to improve the EDC system implementation method, system security, data import and export, andquality control. Results From April 1, 2014 to August 15, 2014, 4030 cases were collected using the EDC system for data management,of which 3847 cases were effective and 183 cases were invalid data, with the efficiency of 95.45%. Conclusions The participation of research group in the construction of EDC system improved the efficiency of data management and quality control.
出处
《中华医学科研管理杂志》
2016年第4期293-299,共7页
Chinese Journal of Medical Science Research Management
基金
中国健康促进基金会健康管理研究所（CHPF2013-1-001）
