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概念:研究者 [2022/02/28 09:02]
老T 		概念:研究者 [2022/02/28 09:08] (当前版本)
老T
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 　　**研究者**：指实施临床试验并对临床试验质量及受试者权益和安全负责的试验现场的负责人。(([[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))  　　**研究者**：指实施临床试验并对临床试验质量及受试者权益和安全负责的试验现场的负责人。(([[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)) 
  
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 　　**Investigator**：A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016)) 　　**Investigator**：A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016))
  
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-　　主要研究者**：临床试验中某一研究中心的负责人。GCP里提到的研究者即指的是主要研究者。广义的研究者也包含次要研究者。+　　**主要研究者**：临床试验中某一研究中心的负责人。GCP里提到的研究者即指的是主要研究者。广义的研究者也包含次要研究者。
  
 　　**Principal Investigator (PI)**：is the physician who leads the conduct of a clinical trial at a study site. (([[https://www.amgen.com/science/clinical-trials/information-for-healthcare-professionals/investigator-resources/|How to Become a Principal Investigator]]. www.amgen.com)) 　　**Principal Investigator (PI)**：is the physician who leads the conduct of a clinical trial at a study site. (([[https://www.amgen.com/science/clinical-trials/information-for-healthcare-professionals/investigator-resources/|How to Become a Principal Investigator]]. www.amgen.com))
  • 概念/研究者.1646038937.txt
  • 最后更改: 2年前
  • 由 老T