问答

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

ArraySUSAR needs to report to the organization? What actions are expected from it? (GCP No. 57 of 2020, Article 48 (1)) @ @ Institutions assume the role of coordination and quality management in the experiment. If SUSAR is reported to the institution, the institution will receive and review it according to the institution's process. According to Article 17 (6) of the GCP, clinical trial institutions shall establish corresponding internal management departments to undertake the management of clinical trials.
2020-07-27 11:26:29
是否研究者和申办方需要分别递交SUSAR到伦理委员会？是否申办方需要分别递交SUSAR给研究者和临床试验机构？快速报告的时限是多少？参考《药物临床试验期间安全性数据快速报告标准和程序》？（GCP 2020年第57号，第二十六条）

2020-07-27 11:25:38
新版GCP规定“研究者、申办者或者药品监督管理部门可以要求伦理委员会提供其标准操作规程和伦理审查委员名单”。如何理解？

2020-06-28 14:48:19
若伦理投票委员与PI属同一科室，是否属于独立于项目？

2020-06-28 14:48:00
新版GCP实施后，伦理委员会的组成，应当遵循哪个法规要求？

2020-06-28 14:47:32
按照新版GCP要求，研究者手册如何审查？研究者手册以后要获得伦理审查同意而不是备案回复了？

2020-06-28 14:47:06

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