问答

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

Article 52 of the 2020 GCP in China mentions that applicants should develop audit procedures for clinical trials and trial quality management systems. Should the sponsor suggest an SOP level audit plan, a specific audit plan for a clinical research project (determining the purpose, method, and frequency of the audit), or develop a corresponding audit plan for a specific audit
2023-06-06 18:24:05
请问患者填写完成的ePRO提交之后，需要研究者进行审阅而从确认是否有遗漏的不良事件吗？

2023-06-06 18:23:40
请问申办方能够收集受试者的姓名和身份证号码吗？什么情况下能够收集？

2023-06-06 18:23:14
肿瘤量表使用的NAS评分表有版权吗？

2023-06-06 18:22:43
请问源数据确认表(Source Data/Document Agreement Log)的使用有什么法规依从性风险吗？

2023-06-06 18:22:18
请问干燥阴凉的温度湿度范围是什么？

2023-06-06 18:21:42

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