问答

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

临床试验结束后，赠药的AE还需要收集吗？

2019-12-27 16:41:55
ArrayIn the "Guidelines for Postmarket Clinical Trials of Drugs (Draft)" released by the National Drug Administration in 2009, it was observed that "Postmarket clinical trials of drugs are intervention studies, different from post market monitoring studies, which are observational non intervention studies. So, is the post marketing surveillance project conducted in China within the scope of clinical trials? Is it necessary to comply with China's GCP and ICH GCP
2019-11-08 10:35:36
大家对CRC填写ICF封面的site基本信息和伦理联系方式，如何看待？是否存在风险？

2019-11-08 10:35:06
如果某site收到FDA的warning letter，该中心的其他项目是否会受到影响？影响有多大？需要如何处理和评估？FDA最终核查的时候，是否会考量这个点？

2019-11-08 10:33:35
有没有法规定义suspected fraud/misconduct?

2019-11-08 10:33:00
on site 监查或稽查的“容错率”有行业标准吗？

2019-11-08 10:30:28

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