问答

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

如果样本采集申请单（Requisition form）上受试者是否禁食【Is subject fasting】勾选了否（No），实际上此次相关检测指标(安全性检测)是需要禁食的，从中心实验室角度，会如何处理未禁食的样本？

2023-11-09 14:40:01
在生物分析的已检测样本再分析ISR检测中，抽样是有推荐比例的，且要求2/3在偏差范围内。如果在试验中按照比例需要抽100个，有97个通过，3个超出范围，这个毋庸置疑ISR是通过的。但是否可以是：仅抽取97个，其中96个通过，1个未通过，但剩下3个需要单独再开一个分析批才能进行，此时前期已经完成的检测合格比例远远大于2/3，即使再补充的3例都是失败的也不影响ISR的通过结论，可以放弃剩余3例样本的检测？

2023-11-09 14:39:43
At present, it is required to conduct literature retrieval on two domestic and foreign databases, with the main purpose of individual case retrieval. So, for varieties that are only sold domestically, only domestic databases are searched, and for varieties that are sold both domestically and internationally, are these searched in both domestic and foreign databases? Is this search method compliant?
2023-10-18 18:10:03
It is known that infusion reactions can cause fever, but there is no mention of infusion reactions and fever in the adverse reactions included in the instruction manual. How can one determine the expected outcome when an adverse reaction is manifested as fever?
2023-10-18 18:09:44
Do we need to revise and report the reports that have already been submitted in the form of tracking reports if errors are found later?
2023-10-18 18:09:28
Can the investigation of individual death cases not go through the Drug Safety Committee? Can relevant departments conduct a joint investigation?
2023-10-18 18:09:12

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