问答

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

There has been some discussion about the need to update the ICH GCP guideline (E6), which is now roughly 14 years old. Have there been any formal discussions on updating the guidance?
2017-07-04 10:00:31
中国是否有对临床样本长期保存的法规规定？ 01st Jun. 2016
2017-07-04 09:51:27
如果伦理会议时法律代表缺席，到会人数过半，此伦理批件是否有效？ 09th May 2016
2017-07-04 09:50:57
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

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