| 中医外治乳腺增生病大样本临床试验的质控体会 |
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| 引用本文： | 孙小慧,刘胜. 中医外治乳腺增生病大样本临床试验的质控体会[J]. 辽宁中医杂志, 2012, 0(5): 818-820 |
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| 作者姓名： | 孙小慧 刘胜 |
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| 作者单位： | 上海中医药大学附属龙华医院中医外科 |
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| 基金项目： | 国家“十一五”科技支撑计划(2008BAI53B052);上海市教委创新团队(沪教委科[2009I6号]) |
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| 摘 要： | 为确保试验结果的真实可靠,在临床试验中按照GCP精神,严格执行操作规范,加强临床试验各个环节的质量控制与监查,规范研究过程,以期提高临床研究水平,探索中医临床试验发展的新思路。
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| 关 键 词： | 药物 临床试验 质量管理 |
Large Sample Quality Control Experience on Clinical Trials of Traditional Chinese Medicine External Treatment of Mammary Glands |
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| SUN Xiao-hui,LIU Sheng. Large Sample Quality Control Experience on Clinical Trials of Traditional Chinese Medicine External Treatment of Mammary Glands[J]. Liaoning Journal of Traditional Chinese Medicine, 2012, 0(5): 818-820 |
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| Authors: | SUN Xiao-hui LIU Sheng |
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| Affiliation: | (Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China) |
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| Abstract: | To ensure that the results of the trial is reliable,according to the GCP spirit in the clinical trials,the operational specification should be carried out strictly,all aspects of clinical trials including quality control and audit should be strengthened,the research process should be standardized in order to improve the clinical research,exploring the new ideas of clinical trials in troditional Chinese medicine. |
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| Keywords: | drugs clinical trials quality management |
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