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概念:irb [2022/02/28 07:19]
老T 		概念:irb [2022/02/28 09:09] (当前版本)
老T
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-　　**伦理委员会**，一般为**独立伦理委员会：**指由医学、药学及其他背景人员组成的委员会，其职责是通过独立地审查、同意、跟踪审查试验方案及相关文件、获得和记录受试者知情同意所用的方法和材料等，确保受试者的权益、安全受到保护。(([[法规:药物临床试验质量管理规范|药物临床试验质量管理规范]]. [[http://www.nmpa.gov.cn|国家药品监督管理局]]（2020年第57号）, 2020))+　　**伦理委员会**，一般为**独立伦理委员会：**指由医学、药学及其他背景人员组成的委员会，其职责是通过独立地审查、同意、跟踪审查试验方案及相关文件、获得和记录受试者知情同意所用的方法和材料等，确保受试者的权益、安全受到保护。(([[法规:药物临床试验质量管理规范#第二章_术语及其定义|药物临床试验质量管理规范（GCP）]]. [[概念:国家药品监督管理局]]. 2020)) 
  
 {{  :概念:伦理委员会.jpg?direct&400|http://www.zunyihospital.com/html/xwdt/ynxw/143897.html}} {{  :概念:伦理委员会.jpg?direct&400|http://www.zunyihospital.com/html/xwdt/ynxw/143897.html}}
 　　**Independent Ethics Committee (IEC)：**An independent body (a review board or a committee, institutional, regional, national, or 　　**Independent Ethics Committee (IEC)：**An independent body (a review board or a committee, institutional, regional, national, or
-supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.(([[法规:ich-gcp|ICH-GCP]]. E6(R2), 2016))+supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016))
  
-　　**Institutional Review Board (IRB): **An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.(([[法规:ich-gcp|ICH-GCP]]. E6(R2), 2016))+　　**Institutional Review Board (IRB): **An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016))
  
 　　IRB和IEC基本上是同一个概念，只是用词上不同。总的来说，IRB是美国的说法，IEC是欧洲和其他国家的说法。 　　IRB和IEC基本上是同一个概念，只是用词上不同。总的来说，IRB是美国的说法，IEC是欧洲和其他国家的说法。
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   * 提供给受试者的其他书面资料；   * 提供给受试者的其他书面资料；
  
-  * [[概念:研究者文件|研究者手册]]；+  * [[概念:研究者手册|研究者手册]]；
  
   * 现有的安全性资料；包含受试者补偿信息的文件；   * 现有的安全性资料；包含受试者补偿信息的文件；
  • 概念/irb.1646032782.txt
  • 最后更改: 2年前
  • 由 老T