问答

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

在ICH GCP E6 R2中的5.0.2 Risk Identification The sponsor should identify risks to critical trial processes and data. Risks should be considered at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial design, data collection, informed consent process).请问如何理解的personnel在 system level呢？有什么例子可以分享吗？谢谢！

2018-08-07 16:00:19
Regarding the issue of insurance for clinical trials, may I ask if the patient follows the plan, or if there is an AE related to the drug (judged by the researcher to be related to the drug), and if the SAE amount reaches the policy scope, can patients apply for insurance for clinical trials? Thank you
2018-08-07 09:45:35
受试者带家属开药，该药为本试验的禁用药，该如何处理？

2018-06-12 14:48:28
参与临床试验的界定是？受试者筛选失败并没有用试验药，这种情况算参加临床试验了吗？

2018-06-12 14:47:54
知情同意书受试者签字日期早于研究者的签字日期（签字日期不是同一天），合规吗？

2018-06-12 14:46:30
知情同意由两位研究者共同进行，知情同意书由两位研究者同时签署，是否存在问题?

2018-06-12 14:46:12

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