中国中医药信息杂志2016，Vol.23Issue(11)：1-3,4,4.DOI:10.3969/j.issn.1005-5304.2016.11.001
中医临床研究一级质量控制管理研究
Study on TCM Clinical Research Primary Quality Control and Management
摘要
Abstract
ObjectiveTo investigate and analyze the current primary quality management situation in TCM clinical studies.Methods One sub-center unit from 39 projects of “Prevention and Treatment of Difficult and Complicated Disease of TCM” plan of the“11th Five-year National Key Technology R&D Program” was chosen. Executive condition of the primary quality control of each unit was under field investigation, and quality control quantitative evaluation indexes were used to conduct quantitative evaluation.Results Results were shown as the forms of statistical description and radar map. The average and median scores of primary quality management were 5.05 and 5.2, respectively. The best and preferable proportions of 39 units were 25.64% and 28.21%. Other 46.15% of these units performed poor. The problem mainly manifested on insufficient frequency and bad normalization of primary quality management, such as comprehensiveness and integrity of inspection contents, cases, problem recordings and problems timely feedback.ConclusionAlthough the primary quality management is widely conducted in TCM clinical studies, there are still some problems to be settled and improved.关键词
中医/临床试验/质量控制/一级质量控制Key words
TCM/clinical experiment/quality control/primary quality control分类
医药卫生引用本文复制引用
程苗苗,翁维良,李睿,陆芳..中医临床研究一级质量控制管理研究[J].中国中医药信息杂志,2016,23(11):1-3,4,4.基金项目
中医药行业科研专项（201107006）；中国中医科学院创新人才培养基金资助项目 （）
