问答

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

ArrayIf the situation described in the plan as "definitely relevant", "possibly relevant", or "unable to determine" is relevant, it will be considered as the PV of the CRO, Do you need to confirm with the applicant that 'possibly unrelated' situations are also relevant, and that meeting SUSAR standards also requires rapid reporting? @ @ According to Article 33 of China's Good Clinical Practice for Drug Trials, the applicant entrusts a contract research organization (CRO) When carrying out work, it is necessary to clarify the specific tasks entrusted and the corresponding standard operating procedures. Therefore, it is recommended that CRO communicate fully with the sponsor before the project is launched, reach an agreement on the criteria for correlation judgment and SUSAR reporting, and implement this standard uniformly in the research project. If there are exceptions, it is necessary to communicate fully with the applicant and researcher in a timely manner, and keep records of the relevant communication and discussion results as well as judgment criteria. There are currently different standards in the industry regarding whether 'possibly unrelated' should correspond to 'relevant'. For example, according to Clinical Trial Regulation (EU) No.536/2014 Q&A, if researchers use WHO's causal relationship classification, it may be considered irrelevant. According to the CDE's "Common Issues in Rapid Reporting of Safety Data during Drug Clinical Trials (Version 1.0)", Q9 mentions that causal relationships are "unable to be evaluated" or "unknown", which are not standardized, but cannot exclude correlations and require rapid reporting according to SUSAR. It is recommended that applicants establish internal procedures based on compliance and scientific considerations to standardize the evaluation criteria for causal relationships. Reference: Clinical Trial Regulation (EU) No.536/2014 Q&A, May 2022 Quick Report on Safety Data during Drug Clinical Trials FAQ (Version 1.0)
2022-05-31 16:09:05
如何界定某个检测项目应该是在中心实验室进行还是在生物分析实验室进行？

2022-05-12 14:03:59
PK样本检测方法交叉验证的时候，在不得已的情况下是否可以使用受试者PK样本？

2022-05-12 14:02:24
样本接收的区域需要有温湿度监控系统吗？

2022-05-12 14:01:36
基于GLP规范，ISO实验室认可标准、药品注册核查要点、以及ALCOA原则的要求等，对于记录的原始性和及时性，我们具体应该怎么理解比较好呢？比如在生物安全柜中进行操作时，实验人员一般是做一系列操作后再写实验记录，不太可能一个步骤后就写记录，那首先怎么算“及时”呢，是实验当天完成记录就算及时，还是必须一个步骤后就写记录算及时？此外，如果操作时顺手在便签上记录了一个时间或者体积等信息，事后再写到受控的实验记录表格中，算誊写记录，会被定为实验记录不是原始记录吗？

2022-05-12 14:00:41
关于二代测序（NGS）的产品，如果要更换不同品牌的建库试剂盒，这种验证要做到什么程度？只选几个标准品用新的试剂盒做一遍实验出结果可以吗？还是要从input，重复性等方面都要做一遍呢？

2022-05-12 13:59:09

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