问答

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

肌无力患者，伴随失语，是否可以等同于没有阅读能力？

2022-06-06 17:29:33
在新冠中和抗体的临床试验中，如果在随访期间出现了抗体复阳导致住院，是否算作SAE？与新冠有关的症状是否记录成AE？

2022-05-31 16:14:01
关于中国上市后产品境外严重不良反应（SADR）报告的要求，如果某产品在境外已上市，境内仍处在临床试验阶段还未上市，那么境外SADR是否需要按照个例递交给中国药监？如何递交？

2022-05-31 16:12:24
CDE抗肿瘤药物安全性信息汇总的文件中提到，申办者和研究者确定为可能无关的按照无关进行汇总。关于如果按照可能无关报告SUSAR，其他的AE以什么样的标准进行归类总结？

2022-05-31 16:11:00
抗肿瘤药物临床研究中，癌痛作为SUSAR进行报告合适吗？

2022-05-31 16:10:00
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

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