中国药物警戒 ›› 2014, Vol. 11 ›› Issue (4): 222-224.

• 药械安全性研究 • 上一篇    下一篇

浅析中医药临床试验研究人员的培训计划

任君, 杨国彦, 韩梅, 刘建平*   

  1. 北京中医药大学循证医学中心,北京 100020
  • 收稿日期:2013-11-06 修回日期:2016-02-03 出版日期:2014-04-08 发布日期:2016-02-03
  • 作者简介:任君,女,硕士,循证医学与中医药临床疗效评价。
  • 基金资助:
    国家重大新药创制课题“创新药物研究开发技术平台建设-临床评价研究标准化操作规程(SOP)课题”(2011ZX09302-006-

Analysis of Training Programs for Clinical Trial Researchers on Traditional Chinese Medicine

REN Jun, YANG Guo-yan, HAN Mei LIU Jian-ping*   

  1. Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100045, China
  • Received:2013-11-06 Revised:2016-02-03 Online:2014-04-08 Published:2016-02-03

摘要: 研究者的研究能力是关系到中医药临床试验质量和临床试验能否顺利完成的重要组成部分。通过确定培训对象、培训的师资,制定培训目标、培训内容、培训方式和培训考评六个方面,浅析如何根据研究目的和临床试验研究方案制定周密、适用的培训计划,以期进一步规范中医药的临床试验。

关键词: 中医药, 临床研究, 研究人员, 培训计划, 研究能力

Abstract: The competence of clinical trial researchers is essential to assure the quality and accomplishment of clinical trials on traditional Chinese medicine. This paper will discuss how to develop a training program for clinical trial researchers on traditional Chinese medicine, according to the research purpose and protocol, from the following six aspects training participants, objectives, contents, approaches, teachers and evaluation, in order to further standardize the clinical trials of traditional Chinese medicine.

Key words: Chinese medicine, clinical trial, researcher, training program, competence

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