临床研究中电子数据质量控制的策略  

Electronic data quality control strategy in clinical research

作　　者：胡健萍 谢高强[2] 姚晨[2] 

机构地区：[1]北京大学第一医院 [2]北京大学临床研究所,100191

出　　处：《中华医学科研管理杂志》2015年第1期40-43,共4页Chinese Journal of Medical Science Research Management

基　　金：首都医学发展科研基金（2009-1026）

摘　　要：目的 制定临床研究中电子数据采集（EDC）的数据质量控制策略.方法 分析EDC工作流程的特点,参考国内外数据管理行业规范,从实际操作层面总结北京大学临床研究所数据管理部在EDC应用中的数据质量控制经验,制定EDC的数据质量控制策略.结果 EDC的应用改变了临床研究的数据管理流程,这决定需要根据其自身特点制定质量控制策略,即：选择恰当的EDC系统、合理设计和构建电子病历报告表（eCRF）、标准化研究中心/用户管理流程、及时准确在线填写eCRF、准确捕获/对接外部电子数据、有计划的数据监查和稽查、及时高效地疑问数据解决、严格的数据库锁定和解锁操作规范.结论 目前我国的临床研究尚处于从传统的纸质数据采集（PDC）向EDC模式转变的初级阶段,制定和采用切合EDC工作流程的质量控制策略可优化数据质量控制的过程和结果.Objective To establish a method for data quality control of clinical research data based on electronic data capture （EDC） system.Methods After analyzed the specific characteristics of EDC＆#39;s workflow process,and also referred to international data management guideline,we established the data quality control strategy by summarizing actual data quality control experience of data management department in Peking University Clinical Research Institute.Results Application of EDC has changed traditional clinical research process,therefore EDC data quality control strategy should be built according to its own process flow,namely,selecting the appropriate EDC system,reasonable design and build electronic case report form （eCRF）,standardization research center / user management processes,timely and accurate on line eCRF filling up,accurately capturing/docking ex ternal electronic data,planned data monitor and auditing,timely and efficient query management,strictly data locking and unlocking operation process,and strict electronic record life cycle monitoring.Conclusions At present time,clinical research in China is still in the earlier stage of the transition from traditional paper-based data collection （PDC） to EDC.Establishing and applying particular quality control strategy will optimize the process and results of data quality control.

关 键 词：临床研究 电子数据采集 质量控制 

分 类 号：R197.324[医药卫生—卫生事业管理]