问答

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

临床试验启动前，主要研究者签署的保密协议，无申办方和机构盖章/签字，是否足够？ 10th May 2016
2017-07-04 09:50:23
如果病人撤销知情同意或退出临床试验，之前采集的样本是否还可以检测？比如某些需要集中检测的样本，在病人撤销知情同意之前就收集了。 19th Apr. 2016
2017-07-04 09:49:38
如果原始记录中没有记录知情同意过程，是否会成为CFDA 临床试验数据核查中的不合格项？15th Sep 2016
2017-07-04 09:48:44
If the position of the page number and version date on the footer of a material submitted for ethics is adjusted during printing, such as when the left page number and right version date are used for ethics submission, and the left version date and right page number are used for printing, the theme content remains unchanged, but the material saved by the ethics committee is different from the one saved in the site file. How to define such a problem? What is the impact? How to handle it?
2017-07-04 09:47:31
Are there any regulations in China regarding the use of assessed or pre approval access to unauthorized medical products?
2017-07-04 09:47:05
When conducting the development or validation of certain testing methods in the central laboratory, it is sometimes necessary to obtain blood from healthy individuals. If this blood sample is taken from volunteers (non clinical trial subjects, such as central laboratory employees), do they need to sign an informed consent form? Is there any relevant regulations in our country that explain this situation?
2017-07-04 09:46:40

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