问答

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

牵头site要整个器械临床试验所有的database，不提供就不给结题。这种做法有依据吗？

2019-12-27 16:43:13
请问临床试验伦理法规等对招募公司有具体要求吗？

2019-12-27 16:42:50
CRO代表申办方承担临床试验的全服务，试验结束后也已经将全部文件转移给申办方后，CRO还需要为申办方保持试验数据多少年？有没有法规、指南可以参考？

2019-12-27 16:42:27
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

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