中医临床研究质量监查的优化  

Optimization of quality monitoring of TCM clinical research

作　　者：李睿[1] 翁维良[1] 李秋艳[1] 田元祥[2] 

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中华中医药杂志》2010年第9期1444-1447,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金："十一五"国家科技支撑计划重大项目资助(No.2006BAI04A21);"重大新药创制"科技重大专项资助(No.2009ZX09301-005);第42批中国博士后科学基金资助项目(No.20070420505);第1批中国博士后特别资助科学基金资助(No.200801167);中国中医科学院自主选题资助(No.Z02119)~~

摘　　要：对多中心中医临床研究开展质量监查,是进行质量控制的有效措施。文章从实施监查的若干重要环节入手,阐述了监查员选派优化、监查前准备优化、监查内容优化以及监查反馈优化方法,其中在监查内容优化中详述了研究进度、遵从研究方案、原始资料、药物管理、真实性核实、CRF表格、知情同意、电子数据、实验室理化数据、(严重)不良事件的监查重点,藉此为提高中医临床研究质量监查提供了理论探讨。Conducting quality monitoring to multi-center clinical research is an effective measure of quality control.This study explored the optimization of some key links of quality monitoring of TCM clinical research,i.e.optimization of CRA appointment,optimization of monitoring preparation,optimization of monitoring items,and optimization of monitoring feedback.For monitoring items,this study emphasized on research progress,protocol compliance,original data conservation,medication management,validity,CRF fill-in,informed consent singing and acquisition,EDC,traceability of lab examination,（severe） adverse event reporting in detail,thus providing the theoretical support for quality monitoring improvement of TCM clinical research.

关 键 词：中医临床研究 质量监查 优化 

分 类 号：R24[医药卫生—中医临床基础]