问答

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

ArrayBefore updating the researchers' manual, researchers should be informed first and communicate with the ethics committee and drug regulatory department if necessary. Why emphasize informing researchers before updating? How to execute notification? (GCP No. 57 of 2020, Article 75) @ @ GCP Article 47 "The applicant is responsible for the safety evaluation of the trial drug during the drug trial. The applicant shall promptly notify the researcher, clinical trial institution, and drug regulatory department of any issues found in the clinical trial that may affect the safety of the subject, affect the implementation of the clinical trial, or change the consent of the ethics committee. Article 48 of the GCP states that applicants shall report adverse drug reactions (SUSAR DSURs) in accordance with the requirements and time limits. The above information may be recorded in the researcher's manual, which is regularly updated, so it is necessary to communicate with the researcher/ethics committee/drug regulatory department before updating.
2020-10-19 16:18:16
“在临床试验期间至少一年审阅研究者手册一次”，请问这个规定的可操作性如何实现，审阅的标准将会是怎么样的？若不需要更新的审阅记录如果处理，是否还要报告伦理？（GCP 2020年第57号，第七十五条）

2020-10-19 16:17:55
“各中心按照方案遵守相同的临床和临床实验室数据的统一评价标准”。如何理解“实验室数据的统一评价标准”？以实验室检查数据为例，各中心间如何实现有效统一？（GCP 2020年第57号，第五十六条（二））

2020-10-19 16:09:19
如何理解和执行新版GCP第五十三条？“若违反试验方案或者本规范的问题严重时，申办者可追究相关人员的责任，并报告药品监督管理部门”。请问句中“药品相关监督管理部门”是指谁？CDE吗？（GCP 2020年第57号，第五十三条（二）：（一）、（二）、（三））

2020-10-19 16:08:58
如何看待药品监督管理部门可以根据工作需要，要求申办者提供稽查报告？（GCP 2020年第57号，第五十二条（五））

2020-10-19 16:08:39
对于申办者制定稽查计划和规程的要求，申办者应准备哪些应对策略？ (GCP 2020年第57号，第五十二条（四））

2020-10-19 16:08:19

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