目的 建立中医临床研究过程质量控制评估指标，以实现对中医临床研究质量控制的量化评价。方法 通过核心小组讨论、专家咨询法，同时结合实地检查发现的问题，在中期量化评估指标的基础上将指标体系扩充至21个，并依此指标体系进行数据采集。以所采集的数据为基础数据，根据专家主观权重意见结合数据特征，通过聚类分析、相关性分析等统计方法进一步筛选和优化指标，最后通过因子分析方法验证最终筛选指标理论层次构建的合理性及评估指标的可应用性。结果 确定了14个量化评估指标进行质控量化评价。结论 确定的评估指标在主观认识与数理依据之间基本一致，依此对中医临床研究进行质控评估是可行的。

Objective To establish the process quality control evaluation indexes for Chinese medical research in order to realize the quantitative evaluation of Chinese medical research quality control. Methods Through leader group discussion，expert consulting and on-site inspection findings，the process quality control indexes developed into 21 based on mid-term evaluation indexes. According to the developed index system，we collected the evaluation data. The process quality control evaluation indexes were further screened and optimized on the basis of data characteristics，with the statistical method of cluster analysis and correlation analysis，together with the subjective weight. The rationality of theory structure and the applicability of the selected indexes were verified by factor analysis method. Results Fourteen indexes were confirmed as the process quality control evaluation indexes for Chinese medical research. Conclusion The results of project ranking between expertise and mathematical analysis are basically consistent，indicating the feasibility of applying this indicators set for quality control evaluation of Chinese medical clinical research.

R285.6

中医药行业科研专项（201107006）；“重大新药创制”科技重大专项（2012ZX09303-010-002）。