标准化数据采集平台构建及在临床试验数据质量控制的应用  

Construction of standardized data capture system and its application in quality control of clinical trial data

作　　者：齐潇[1] 肖婉[1] 陈卉[1] 涂娇[1] 倪平[2] 许林勇[1,3] 

机构地区：[1]中南大学湘雅公共卫生学院流行病与卫生统计学系 [2]中南大学湘雅医院 [3]中南大学湘雅三医院药物临床研究统计分析中心

出　　处：《中国临床药理学与治疗学》2016年第12期1384-1388,1398,共6页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：规范、完整的试验数据是临床试验统计分析的先决条件,也是临床试验结果真实可信的有力保障。当前电子数据采集系统(EDC)以其能够优化试验设计、保障数据真实可靠、控制试验成本和风险等优势得到了国内临床试验数据管理行业的极大重视,但也存在数据采集规范化、标准化不足的问题。本文以基于Clin Capture二次开发的药物临床试验数据采集平台e Clinica XY为例,阐述了标准化数据采集平台的架构设计、遵循标准以及在临床试验数据质量管控方面的优势特点。Standardized and intact clinic trial data is the key of reliability of clinical trial results,as well as the prerequisite for data analysis. Nowadays,Electronic Data Capture（ EDC） has got attention by clinical trial data management for its reputation of trial design optimization,data quality ensurement,trial risk and cost control. Meanwhile,the EDC still has problems in low quality of standardization data collection. This study explains the design and standard of standardized data capture system e Clinical XY based on second clinical trail data capture system which was developed by Clin Capture.And the advantages of this system in clinical trial data quality control is also discussed in this paper.

关 键 词：临床试验 数据采集平台 标准化 数据质量控制 

分 类 号：R319[医药卫生—基础医学]