问答

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

2003年版本GCP附录2“临床试验保存文件”中要求那些原件，现在是否都不需要保存了？《药物临床试验必备文件保存指导原则》对于原件的保存要求不多。（GCP 2020年第57号，第八章）

2020-10-19 16:19:38
核证副本应该在什么时间生成？如果在核证副本上勘误，源文件是否要同步修改？如果源文件因医院要求不能修改，核证副本上的修正是否算数？（GCP 2020年第57号，第七十九条）

2020-10-19 16:19:19
在监查与稽查中，必备文件的list参考依据是什么？（GCP 2020年第57号，第七十九条）

2020-10-19 16:18:55
“定期测试或检查恢复读取能力”这个时限有什么要求？是否需要保留检查记录？（GCP 2020年第57号，第七十九条）

2020-10-19 16:18:37
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

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