问答

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

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
妊娠事件和不良事件有何区别？

2019-06-05 11:23:04
很多器械试验，医院是“打包收费”，即把手术费和器械费包含在一起，一次性收费。申办者提供的试验器械或对照器械宣称是免费的，实际上医院对病人又是收费的，病人没有享受到所谓的免费器械，医院收到了免费器械，还向受试者收了费。“打包费用”医院拆不开，医院也不知晓器械费用是多少。如何看待这一现象？

2019-06-05 11:19:06
临床试验过程中，需要给受试者进行理赔，可以把受试者的个人资料提供给申办者进行报销吗？如果提供了，是不是又涉及受试者的隐私？

2019-06-05 11:12:42
医院影像机器无法录制影像，需U盘才能导出影像数据进行保存，这种情况下U盘存储的数据是否可以作为源数据？如将影像数据刻盘，是否可作为源数据?

2019-06-05 10:42:10

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