我院药物临床试验电子数据采集系统的建立及应用  

Establishment and Application of Electronic Data Capture System in Drug Clinical Trials of Our Hospital

作　　者：赵佳[1,2] 姜春梅[1] 郭媛[1] 李明明[1] 温雯[1] 郎丽杰[1] 李国信[1] 

机构地区：[1]辽宁省中医药研究院/辽宁中医药大学附属第二医院,沈阳110034 [2]第四军医大学军事预防系卫生统计学教研室,西安710032

出　　处：《中国药房》2016年第4期452-455,共4页China Pharmacy

基　　金：国家"十二五"重大新药创制项目(No.2012ZX093-03017);国家临床重点专科建设项目;国家中医药管理局临床中药学重点学科;辽宁中医药大学杏林学者青蓝工程

摘　　要：目的:保证药物临床试验电子数据采集(EDC)系统稳定运行,提高药物临床试验质量。方法:从质量管理流程的制订、数据标准化的建立、试验项目管理、日常管理、试验项目设计、系统操作、系统功能等方面介绍我院EDC系统的质量管理体系。结果与结论:我院建立的EDC质量管理体系以数据质量的可归因性、易读性、同时性、原始性和准确性为原则,实现了数据标准化。通过资料备案、人员培训、制订数据管理计划、故障应急处理和数据库备份进行试验项目的管理和日常管理,制订了相关的标准操作规程、程序文件、操作手册或质量记录,实现了支持数据的多重验证核查、数据锁定与导出、自动生成试验报告等功能,可提高临床试验过程中产生数据的真实性、准确性和完整性,为进一步数据挖掘工作奠定了基础。OBJECTIVE：To ensure the stability of electronic data capture（EDC）system in drug clinical trials and to improve the quality of drug clinical trials. METHODS：The quality control system for EDC system was established and introduced from the formulation of quality control process,establishment of data standard,trial project management,daily management,trial project design,system operation,system function,etc. RESULTS CONCLUSIONS：Data standard have been achieved through establishing EDC quality control system by our hospital based on attributable,legible,contemporaneous,original and accurate principle.The management of trial project and daily management are conducted through data registration,staff training,the formulation of data management plan,fault emergency treatment,database backup;multiple verification of support data,data lock and export,trial report autogeneration and other functions have been realized by formulating related standard operation instruction,program file,operation manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foundation for further data mining.

关 键 词：药物临床试验 电子数据采集 质量管理体系 功能 应用 

分 类 号：R95[医药卫生—药学]