| 引用本文:李睿1，翁维良1，田元祥2，耿涛3，陆芳1，赵阳1.中医临床研究伦理质量控制及量化评价[J].世界中医药,2015,10(03):. |
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| 中医临床研究伦理质量控制及量化评价 |
| Quantitative Evaluation and Quality Control of Ethics of Chinese Clinical Research |
| 投稿时间：2014-05-23 |
| DOI：10.3969/j.issn.1673-7202.2015.03.033 |
| 中文关键词: 中医临床研究 伦理 质量控制 评价 |
| English Keywords:Chinese clinical research Ethics Quality control Evaluation |
| 基金项目:中医药行业科研专项：中医慢病临床科研体系及其成果转化应用模式研究（编号：201107006）；“重大新药创制”科技重大专项创新药物研究开发技术平台建设（编号：2012ZX09303-010-002） |
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| 中文摘要: |
| 目的：建立中医临床伦理质量控制评价指标，实现对伦理质量的量化评价。方法：依据指标对科技部“十一五”国家科技支撑计划重大项目的全部课题组进行了中期和结题两阶段的量化评分，通过雷达图描述各课题的实际得分，利用卡方检验和相关性方法分析伦理质控水平对于课题总体质控得分的影响。结果：从中期到结题，伦理质控得分占质控评估总分的重要性呈下降趋势。结论：在试验早期阶段伦理质控的水平对于课题整体质量控制水平的影响更为重要。 |
| English Summary: |
| In order to set up ethics quality control index of Chinese clinical research,and realize the quantitative evaluation of the ethics quality.Methods:In accordance with the quality control index,all the projects of “Prevention and Treatment of Difficult and Complicated Disease of TCM ” plan of the “11th Five-year National Key Technology R&D Program” were given a mid-term and concluding evaluation,and the scores were described with radar map method,and the influence of ethical level of quality control to total quality control scores was analyzed with chi-square test and correlation methods.Results:From mid-term stage to concluding stage,the importance of ethical quality score of total quality control score was in a downward trend.Conclusion:In the early stage,ethical quality control level shows greater impact on the total quality control level. |
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