FDA知情同意指南第五讲Q&A2(完结篇)

文摘   2023-10-07 20:00   北京  

     本讲通过学习最后八个问题的解答完成本知情同意指南(Informed Consent Guidance for Institutional Review Boards Clinical Investigators and Sponsors)的学习。这也属于自我学习的过程,如有解释不当的地方,欢迎指正并共同探讨。

9.Who can serve as a legally authorized representative (LAR) and what is their role?

10.How can informed consent be obtained through electronic methods?

11.Can a subject participate in more than one clinical investigation simultaneously?

12.How should data be handled when an enrolled subject decides to withdraw from a trial?

13.What steps should be taken to inform subjects when a study is suspended or terminated?

14.Should subjects be informed of aggregate study results at the completion of a trial?

15.Is informed consent required to review patient records?

16.How should subjects be informed of new information that may affect their willingness to continue participation in the research?

课程播放地点:临研晖语网站和临研晖语APP

桌面端访问地址:https://www.clinvoice.cn

手机端访问地址:https://m.clinvoice.cn





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