问答

Statement: The content of this Q&A reflects the current views of CQAF, for mutual learning and exchange among industry colleagues.

FDA在中国成立办公室，在中国有哪些职责？是否会进行核查？

2019-07-25 15:41:59
医院要求去site的人员提供身份证复印件有什么法律依据？医院有权力收我们的身份证复印件吗？

2019-07-25 15:39:52
大家遇到过中心要求锁库之前必须稽查吗？（此前申办方已对中心进行过稽查，但稽查后有新受试者入组）申办方的担心是：稽查计划并不会涵盖所有研究中心，也不会都安排在锁库前，想了解行业操作方式。

2019-07-25 15:38:53
有关方案违背严重程度的分类或者判断，是否有相关的法规进行描述？

2019-07-25 15:37:45
Due to the innovative nature of the instrument products used, it is necessary for the manufacturer's engineer to follow up, and the angiography data needs to be sent to the engineer for review before the surgery. But it was found that the research center was unable to conceal patient information such as name pinyin, age, and gender when sending images, which means that the applicant representative can obtain patient information. What are the risks described above and how to effectively control them. Supplement: The original intention of the above operations is to facilitate engineers to provide precise advice to researchers during surgical follow-up, prevent or solve unexpected situations, and does not involve the evaluation of subject eligibility
2019-06-05 14:19:26
关于SAE开始的时间。如：患者在2018/02/19出现恶心，Ⅰ级。但是在2019/02/20是恶心加重延迟出院。那么SAE开始的时间是什么时候？

2019-06-05 11:24:29

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