中医临床研究质量的监查工作

Quality inspection of clinical research in traditional Chinese medicine

本文从中医临床研究四级质量控制方法入手,阐述各级质量控制(一级检查、二级监查、三级稽查和四级视察)方法的实施过程以及要求。作者根据对"十一五"国家科技支撑计划"重大疑难疾病中医防治研究"项目的全部41个在研课题所进行的针对执行过程的联合监查结果,分析了四级质量控制体系以及联合监查模式的保障作用,提出了各级质量控制体系及联合监查模式在执行中存在的问题,并探讨其应加以修订完善的内容,为进一步完善中医临床研究质量监查工作提供了理论支持。

Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine （TCM）,we elaborated the implementation process and demands of quality control measures of each level, including quality control,monitoring,auditing,and inspection.On the basis of joint inspection experience of 41 projects of the＂Prevention and Treatment of Difficult and Complicated Diseases of TCM＂plan of the＂11th Five-year National Key Technology RD Program＂,we analyzed the ensuring effect of 4-level quality control system and joint inspection model,and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model.Finally we investigated what should be revised in the quality control system and joint inspection model,thus providing the theoretical support for quality inspection improvement of TCM clinical research.