期刊文献+

谈伦理审查质量 被引量:6

Quality in Ethics Committee Review
暂未订购
导出
摘要 针对伦理审查质量的含义进行了深入的剖析,对伦理审查质量体系的各个要素,包括法规框架,人员资质、独立性、管理和资源、审查工作的一致性和可预见性、明晰的职责流程等进行了逐一解释,同时提出质量管理环节中建立伦理委员会的内部评估机制,并定期进行独立于伦理委员会的第三方评估的重要意义。 The author explains the meaning of "Quality in Ethics Committee Review", introducing the quality elements which include the regulatory framework, the members' qualification, the independence, resource and administration, the consistency and predictability in review, standard operating procedure. He highlights that the internal and external review system play an important role in quality management.
出处 《医学与哲学(A)》 北大核心 2011年第5期6-7,11,共3页 Medicine & Philosophy:Humanistic & Social Medicine Edition
关键词 审查质量 独立性 一致性 可预见性 内部评估 外部评估 review quality, independence, consistency, predictability,internal review, external review
  • 相关文献

参考文献6

  • 1World Medical Association. Declaration of Helsinki: Ethical Princi pies for Medical Research Involving Human Subjects [R/OL]. (2008 - 10) [2011 - 03 - 21]. http://www. wma. net/en/ 30publications/ 10policies/b3/ index. html.
  • 2CIOMS--WHO. International Ethical Guidelines for Biomedical Re- search Involving Human Subjects[R/OL]. [2011-03-21].http:// www. eioms. ch/frame_guidelines_nov_2002. html.
  • 3WHO TDR. Guidelines for ethics committees that review biomedic- al research TDR/PRD/ETHICS/2000. 1 [R/OL]. [2011- 03- 20]. http://apps, who. int/tdr/publications/training- guideline- publications/operational- guidelines - ethics - biomedical - re- search/pdf/ethics. pdf.
  • 4WHO. Surveying and Evaluating Ethical Review Practices. TDR/ PRD/ETHICS/2002. 1[R]. [2011 - 03- 21].http://www. who.int/ tdrold/ publications/ publica tions/ pdf / ethics2. pdf.
  • 5European Medicines Agency. ICH Topic E6 (R1) Guideline for Good Clinical Practice[R/OL]. (2002 - 07) [2011 - 03- 21]. ht tp://www, ema. europa. eu/docs/en--GB/document liabrary/Sci entific_guideline/2009/09/WC500002874. pdf.
  • 6中国国家食品药品监督管理局.药物临床试验质量管理规范(局令第三号)[R/OL].http://www.sda.gov.cn/WS01/CL0053/24473.html.

同被引文献89

引证文献6

二级引证文献19

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部