Article(id=1321425875896218270, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425812331549069, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.15.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1766160000000, acceptedDateStr=2025-12-20, onlineDate=1792982079718, onlineDateStr=2026-10-26, pubDate=1786723200000, pubDateStr=2026-08-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982079718, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982079718, creator=13701087609, updateTime=1792982079718, updator=13701087609, issue=Issue{id=1321425812331549069, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='15', pageStart='1569', pageEnd='1680', issueExtLink='null', onlineDate='null', pubDate='1786723200000', pubDateStr='2026-08-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982064564, creator='13701087609', updateTime=1792982904202, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429334083097400, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425812331549069, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429334087291705, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425812331549069, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1644, endPage=1648, ext={EN=ArticleExt(id=1321425876139487903, articleId=1321425875896218270, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Optimizing the quality management system by establishing classification criteria for quality control findings in drug clinical trials, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To construct a scientifically sound four-level classification system for quality control (QC) findings in drug clinical trials, in order to optimize the clinical trial quality management system.

Methods:

A four-level classification system was established by analyzing the clinical trial process, clarifying the relationship among risk assessment and improvement measures, and applying the scenario reverse verification method.

Results:

The four-level classification enabled the quantification and multi-dimensional comparison of clinical trial quality risks, as well as accurate root cause analysis of quality issues and rapid closed-loop improvement.

Conclusion:

The optimized quality management system can efficiently identify core risks in clinical trial quality and improve the efficiency of risk assessment and corrective actions.

, authors=Shu-hua ZHAO1, Xiao-hong LIU1, Zhi-ying FU1, Yun MEI2, Ying GONG3, Jing-jing CHEN3, Pan-jun GAO2, Min JIANG4, *, authorsList=Shu-hua ZHAO, Xiao-hong LIU, Zhi-ying FU, Yun MEI, Ying GONG, Jing-jing CHEN, Pan-jun GAO, Min JIANG, authorCompany=null, correspAuthors=Min JIANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1321425876550529696, articleId=1321425875896218270, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=通过构建药物临床试验质量问题分类标准优化质量管理体系, columnId=1236331741447778310, journalTitle=中国新药杂志, columnName=药物临床试验规范与进展专栏, runingTitle=null, highlight=null, articleAbstract=
目的:

构建科学合理的药物临床试验质量问题四级分类标准,用于优化临床试验质量管理体系。

方法:

通过对临床试验的流程分析、风险评估与改进措施间的关系梳理,运用场景逆向验证方法,建立临床试验质量问题四级分类标准。

结果:

四级分类标准实现了临床试验质量风险量化和多维度的比较,以及质量问题的精准根因分析与快速闭环的改进。

结论:

优化后的质量管理体系能够高效识别临床试验质量核心风险,提升风险评估效率与整改效能。

, authors=赵淑华1, 刘晓红1, 傅志英1, 梅昀2, 龚瑛3, 陈晶晶3, 高盼君2, 江旻4, *, authorsList=赵淑华, 刘晓红, 傅志英, 梅昀, 龚瑛, 陈晶晶, 高盼君, 江旻, authorCompany=null, correspAuthors=江旻, authorNote=

刘晓红,女,硕士,副主任护师,主要从事临床试验实施和临床研究。E-mail: 。

赵淑华,女,硕士,副研究员,研究方向:临床试验质量管理,E-mail: 。

, correspAuthorsNote=
* 江旻,女,硕士,副主任药师,研究方向:临床试验管理和信息化研究。E-mail: 。
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赵淑华,女,硕士,副研究员,研究方向:临床试验质量管理,E-mail: 。

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赵淑华,女,硕士,副研究员,研究方向:临床试验质量管理,E-mail: 。

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通过构建药物临床试验质量问题分类标准优化质量管理体系
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赵淑华 1 , 刘晓红 1 , 傅志英 1 , 梅昀 2 , 龚瑛 3 , 陈晶晶 3 , 高盼君 2 , 江旻 4, *
中国新药杂志 | 药物临床试验规范与进展专栏 2026,35(15): 1644-1648
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中国新药杂志 |药物临床试验规范与进展专栏 2026 , 35 (15) : 1644 -1648
通过构建药物临床试验质量问题分类标准优化质量管理体系
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赵淑华1 , 刘晓红1 , 傅志英1, 梅昀2, 龚瑛3, 陈晶晶3, 高盼君2, 江旻4, *
作者信息
  • 1北京大学肿瘤医院暨北京市肿瘤防治研究所国家药物临床试验机构,恶性肿瘤发病机制及转化研究教育部重点实验室,北京 100142
  • 2医渡云(北京)技术有限公司,北京 100101
  • 3辉瑞(中国)研究开发有限公司,上海 200135
  • 4北京大学肿瘤医院暨北京市肿瘤防治研究所国家药物临床试验机构,消化系肿瘤整合防治全国重点实验室,恶性肿瘤转化研究北京市重点实验室,北京 100142
通讯作者:
* 江旻,女,硕士,副主任药师,研究方向:临床试验管理和信息化研究。E-mail: 。
作者简介:

刘晓红,女,硕士,副主任护师,主要从事临床试验实施和临床研究。E-mail: 。

赵淑华,女,硕士,副研究员,研究方向:临床试验质量管理,E-mail: 。

Optimizing the quality management system by establishing classification criteria for quality control findings in drug clinical trials
Shu-hua ZHAO1 , Xiao-hong LIU1 , Zhi-ying FU1, Yun MEI2, Ying GONG3, Jing-jing CHEN3, Pan-jun GAO2, Min JIANG4, *
Affiliations
  • 1Key Laboratory of Carcinogenesis & Translational Research (Ministry of Education/Beijing), National Drug Clinical Trial Center, Peking University Cancer Hospital & Institute, Beijing 100142, China
  • 2Yidu Tech Inc, Beijing 100101, China
  • 3Pfizer (China) Research and Development Co., Ltd., Shanghai 200135, China
  • 4State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis & Translational Research, National Drug Clinical Trial Center, Peking University Cancer Hospital & Institute, Beijing 100142, China
出版时间: 2026-08-15 doi: 10.20251/j.cnki.1003-3734.2026.15.010
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目的:

构建科学合理的药物临床试验质量问题四级分类标准,用于优化临床试验质量管理体系。

方法:

通过对临床试验的流程分析、风险评估与改进措施间的关系梳理,运用场景逆向验证方法,建立临床试验质量问题四级分类标准。

结果:

四级分类标准实现了临床试验质量风险量化和多维度的比较,以及质量问题的精准根因分析与快速闭环的改进。

结论:

优化后的质量管理体系能够高效识别临床试验质量核心风险,提升风险评估效率与整改效能。

临床试验  /  质量管理  /  质量问题分类标准
Objective:

To construct a scientifically sound four-level classification system for quality control (QC) findings in drug clinical trials, in order to optimize the clinical trial quality management system.

Methods:

A four-level classification system was established by analyzing the clinical trial process, clarifying the relationship among risk assessment and improvement measures, and applying the scenario reverse verification method.

Results:

The four-level classification enabled the quantification and multi-dimensional comparison of clinical trial quality risks, as well as accurate root cause analysis of quality issues and rapid closed-loop improvement.

Conclusion:

The optimized quality management system can efficiently identify core risks in clinical trial quality and improve the efficiency of risk assessment and corrective actions.

clinical trials  /  quality of management  /  classification of quality control findings
赵淑华, 刘晓红, 傅志英, 梅昀, 龚瑛, 陈晶晶, 高盼君, 江旻. 通过构建药物临床试验质量问题分类标准优化质量管理体系. 中国新药杂志, 2026 , 35 (15) : 1644 -1648 . DOI: 10.20251/j.cnki.1003-3734.2026.15.010
Shu-hua ZHAO, Xiao-hong LIU, Zhi-ying FU, Yun MEI, Ying GONG, Jing-jing CHEN, Pan-jun GAO, Min JIANG. Optimizing the quality management system by establishing classification criteria for quality control findings in drug clinical trials[J]. Chinese Journal of New Drugs, 2026 , 35 (15) : 1644 -1648 . DOI: 10.20251/j.cnki.1003-3734.2026.15.010
  • 首都卫生发展科研专项资助项目(2022-2Z-2153)
  • 北自然-海淀原始创新联合基金资助项目(L232032)
  • 北京市属医院科研培育项目(PG2023018)
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2026年第35卷第15期
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doi: 10.20251/j.cnki.1003-3734.2026.15.010
  • 首发时间:2026-10-26
  • 出版时间:2026-08-15
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  • 录用日期:2025-12-20
基金
首都卫生发展科研专项资助项目(2022-2Z-2153)
北自然-海淀原始创新联合基金资助项目(L232032)
北京市属医院科研培育项目(PG2023018)
作者信息
    1北京大学肿瘤医院暨北京市肿瘤防治研究所国家药物临床试验机构,恶性肿瘤发病机制及转化研究教育部重点实验室,北京 100142
    2医渡云(北京)技术有限公司,北京 100101
    3辉瑞(中国)研究开发有限公司,上海 200135
    4北京大学肿瘤医院暨北京市肿瘤防治研究所国家药物临床试验机构,消化系肿瘤整合防治全国重点实验室,恶性肿瘤转化研究北京市重点实验室,北京 100142

通讯作者:

* 江旻,女,硕士,副主任药师,研究方向:临床试验管理和信息化研究。E-mail: 。
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https://castjournals.cast.org.cn/joweb/zgxyzz/CN/10.20251/j.cnki.1003-3734.2026.15.010
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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