问答

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

药物警戒主文件是否需要包括临床试验内容？

2023-09-27 09:50:37
新药PK检测，前期数据很少，lab使用了项目受试者采集的血样进行方法学验证以确定线性；（方案中纳入的也是健康受试者），想问一下这个是否是合规或者不合规？具体参考法规哪一条？既往见到的都是用健康受试者的空白机制来做方法学验证的。

2023-08-21 20:25:55
在设盲试验中，生物分析实验室如何具体确保检测报告处于盲态？哪些人员或流程需要提前处于盲态呢？可否具体举例。

2023-08-21 20:24:09
ArrayHow to ensure the accuracy and compliance of data during data transmission and integration into databases? How to protect privacy and remain blind
2023-08-21 20:23:41
At the baseline examination of the patient, all laboratory test indicators were normal. Some laboratory test indicators showed abnormalities after medication. Do researchers need to record medical judgments that have clinical significance and are believed to be related to the underlying disease (target indication), so there is no need to report adverse events
2023-08-02 09:17:55
在临床试验入组阶段，申办者要求研究者把受试者筛选期间的所有检查报告和既往病史资料，经过所谓的“脱敏”处理后，发给申办者的医学监查员，经后者确认批准后，才能确定受试者是否可以入组。在ICF中，并未涵盖将受试者资料发送到临床试验机构之外地方的表述。请问这种操作有合适吗？

2023-08-02 09:17:33

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