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概念:最小风险 [2022/02/18 09:08]
老T 		概念:最小风险 [2022/02/28 07:26] (当前版本)
老T
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 ====== 最小风险 Minimal Risk ====== ====== 最小风险 Minimal Risk ======
  
-**最小风险**指试验中预期风险的可能性和程度不大于日常生活、或进行常规体格检查或心理测试的风险。(([[法规:药物临床试验伦理审查工作指导原则|药物临床试验伦理审查工作指导原则]], 国家食品药品监督管理局, 2010))+\\ 
 +　　**最小风险**指试验中预期风险的可能性和程度不大于日常生活、或进行常规体格检查或心理测试的风险。(([[法规:药物临床试验伦理审查工作指导原则|药物临床试验伦理审查工作指导原则]], [[概念:国家药品监督管理局]]. 2010))
  
-**Minimal risk** means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.(([[https://www.fda.gov/patients/informed-consent-clinical-trials/minimal-risk|www.FDA.gov]]))+　　**Minimal risk** means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.(([[https://www.fda.gov/patients/informed-consent-clinical-trials/minimal-risk|www.FDA.gov]]))
  
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  • 概念/最小风险.1645175319.txt
  • 最后更改: 2年前
  • 由 老T