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 ZHAO
1, Xiao-hong LIU
1, Zhi-ying FU
1, Yun MEI
2, Ying GONG
3, Jing-jing CHEN
3, Pan-jun GAO
2, Min JIANG
4, *, 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=
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1Key Laboratory of Carcinogenesis & Translational Research (Ministry of Education/Beijing), National Drug Clinical Trial Center, Peking University Cancer Hospital & Institute, Beijing 100142, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425877376807601, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425875896218270, authorId=1321425877234201262, language=CN, stringName=赵淑华, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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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, bio={"content":"
赵淑华,女,硕士,副研究员,研究方向:临床试验质量管理,E-mail: gcp_zhaosh@bjcancer.org。
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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: gcp_zhaosh@bjcancer.org。
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1Key Laboratory of Carcinogenesis & Translational Research (Ministry of Education/Beijing), National Drug Clinical Trial Center, Peking University Cancer Hospital & Institute, Beijing 100142, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425879419433659, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425875896218270, authorId=1321425879251661496, language=CN, stringName=傅志英, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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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, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1321425876898656929, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425875896218270, xref=1, ext=[AuthorCompanyExt(id=1321425876907045538, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425875896218270, companyId=1321425876898656929, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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2Yidu Tech Inc, Beijing 100101, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425879666897600, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425875896218270, authorId=1321425879520096957, language=CN, stringName=梅昀, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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