问答

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

Do all modifications to source data require a record of the reason for the modification? (GCP 2020 No. 57, Chapter 4) @ @ Yes. The modification of source data should leave a trace to understand what was before the modification and what was after the modification (which cannot conceal the initial data), and the reason for the modification needs to be explained. The implementation of electronic records is relatively simple (which can be used as a procedural requirement), but for paper records, it is a new requirement.
2020-11-07 09:53:25
如何建立临床试验专用的电子病历系统？（GCP 2020年第57号，第四章）

2020-11-07 09:52:48
如何理解“以患者为受试者的临床试验，相关的医疗记录应当载入门诊或者住院病历系统”？不再使用“研究病历”吗？（GCP 2020年第57号，第四章）

2020-11-07 09:52:16
如何理解研究者、机构和机构办之间的关系？（GCP 2020年第57号，第四章）

2020-11-07 09:51:33
ArrayHow to define whether a child meets the conditions for signing informed consent? Do you need to define competency standards in the plan? (GCP No. 57 of 2020, Chapter 4, Article 23) @ @ How to define the ability of a child to sign an informed consent form can be referred to in Article 19 of the Civil Code. Minors over the age of eight can sign a written consent form by themselves. In addition, guidelines for children's informed consent can be established at the program or project level to guide standard operations within the same program and obtain ethical approval. Further considerations can be found in the following documents: ICH E11 (R1): Appendix: Clinical Investigation of Medical Products in the Pediatric Population link: http://www.cde.org.cn/guide.do?method=downloadAtt&codeStr=5b36d6fd50f251fc&type2=1NMPA Guidelines for Clinical Trials of Pediatric Population Drugs (2016 No. 48) Link: https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20160307164401912.html
2020-11-07 09:50:56
病史记录中是否必须记录知情的具体时间点？（GCP 2020年第57号，第四章 第二十三条）

2020-11-07 09:50:14

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