| 中医临床研究质量的监查工作 |
| |
| 引用本文： | 李睿,翁维良,田元祥,李秋艳,陆芳. 中医临床研究质量的监查工作[J]. 中西医结合学报, 2010, 8(5): 406-409. DOI: 10.3736/jcim20100502 |
| |
| 作者姓名： | 李睿 翁维良 田元祥 李秋艳 陆芳 |
| |
| 作者单位： | 1. 中国中医科学院西苑医院GCP中心,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 |
| |
| 基金项目： | 国家科技支撑计划重大项目 |
| |
| 摘 要： | 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。
|
| 关 键 词： | 临床研究 质量控制 中医学 |
Quality inspection of clinical research in traditional Chinese medicine |
| |
| Rui LI,Wei-liang WENG,Yuan-xiang TIAN,Qiu-yan LI,Fang LU. Quality inspection of clinical research in traditional Chinese medicine[J]. Journal of Chinese integrative medicine, 2010, 8(5): 406-409. DOI: 10.3736/jcim20100502 |
| |
| Authors: | Rui LI Wei-liang WENG Yuan-xiang TIAN Qiu-yan LI Fang LU |
| |
| Affiliation: | Rui LI~1,Wei-liang WENG~1,Yuan-xiang TIAN~2,Qiu-yan LI~1,Fang LU~1 1.GCP Clinical Center,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China 2.Institute of Basic Research in Clinical Medicine,Beijing 100700,China |
| |
| Abstract: | 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 thePrevention and Treatment of Difficult and Complicated Diseases of TCMplan of the11th Five-year National Key Technology R&D Program,we analyzed the ensuring effect of 4-level quality c... |
| |
| Keywords: | clinical study quality control traditional Chinese medicine |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
|
