问答

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

请问在香港做临床试验，研究药物的管理需要遵从哪些法规？

2023-08-02 09:16:20
在远程实验中，通过第三方提供兼职护士进行居家护理，如果该护士不是该研究中心的注册护士，这种操作是否有合规性风险？

2023-06-06 18:24:29
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

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