title: [Quality inspection of clinical research in traditional Chinese medicine].
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 the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D 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.
authors.affiliation: China Academy of Chinese Medical Sciences, Beijing 100091, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Li
authors.forename: Wei-liang
authors.initials: WL
authors.lastname: Weng
authors.forename: Yuan-xiang
authors.initials: YX
authors.lastname: Tian
authors.forename: Qiu-yan
authors.initials: QY
authors.lastname: Li
authors.forename: Fang
authors.initials: F
authors.lastname: Lu
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000592:standards*; D011786:Quality Control