FDA知情同意指南第五讲Q&A1

文摘   2023-09-30 20:00   北京  

     本讲通过以下八个问题的解答,告知大家在临床试验过程中,当入组涉及这八类人群时,就知情同意这个主题,应该从哪些方面进行考虑,关注点是什么。

1.What are some considerations for enrolling a child into a clinical investigation?

2.Are there any additional protections required when enrolling children who are wards of the state?

3.What are some considerations for enrolling non-English speaking subjects?

4.What process should be followed when it is expected that subjects who do not understand English will be enrolled?

5.What process should be followed when the enrollment of subjects who do not understand English is not expected?

6.What should be considered when enrolling subjects with low literacy and numeracy?

7.What should be considered when enrolling subjects with physical or sensory disabilities?

8.What should be considered when enrolling adult subjects with impaired consent capacity? 


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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