中国药房Issue(4)：452-454,3.DOI:10.6039/j.issn.1001-0408.2016.04.06
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
摘要
Abstract
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 estab-lishing 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 da-ta 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,op-eration manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foun-dation 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Key words
Drug clinical trials/Electronic data capture/Quality control system/Function/Application分类
医药卫生引用本文复制引用
赵佳,姜春梅,郭媛,李明明,温雯,郎丽杰,李国信..我院药物临床试验电子数据采集系统的建立及应用[J].中国药房,2016,(4):452-454,3.基金项目
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 （）
