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Article(id=1322624485841285413, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.19.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1785081600000, receivedDateStr=2026-07-27, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793267850598, onlineDateStr=2026-10-29, pubDate=1791993600000, pubDateStr=2026-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793267850598, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793267850598, creator=13701087609, updateTime=1793267850598, updator=13701087609, issue=Issue{id=1322624482217415197, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='19', pageStart='2017', pageEnd='2128', issueExtLink='null', onlineDate='null', pubDate='1791993600000', pubDateStr='2026-10-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1793267849735, creator='13701087609', updateTime=1793268229475, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322626075042100008, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322626075046294313, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2028, endPage=2037, ext={EN=ArticleExt(id=1322624486013251878, articleId=1322624485841285413, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=New requirements and response strategies for principal investigators and clinical trial institutions under the revised Good Clinical Practice guidelines, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To analyze the new requirements imposed on principal investigators and clinical trial institutions by the revised Good Clinical Practice (GCP) guidelines, and to explore the challenges currently facing the industry along with corresponding response strategies.

Methods:

Through an in-depth interpretation of the revised GCP provisions and a comparative analysis with the 2020 version, integrated with the core principles of ICH E6(R3), this study examined compliance and the current status from the perspectives of legal liability delineation, participant protection, data integrity, and quality management system development.

Results:

The legal status of the principal investigator as the “ultimate responsible party at the clinical trial site” was established, and it was proposed that clinical trial institutions should build and ensure the effective operation of a full process quality management system. In addition, an intelligent management pathway was identified, embedding digital tools into management processes to address practical challenges including technical barriers, cost investments, and cognitive biases.

Conclusion:

The implementation of the revised GCP signifies a shift in China’s clinical trial management from the former “compliance oriented” approach toward “quality-by-design” and “risk-based” approaches. Principal investigators and clinical trial institutions should leverage digital transformation and the co-evolution of management paradigms to create an intelligent quality ecosystem, achieving a substantial leap in clinical trial performance while maintaining full regulatory compliance.

, authors=Luo-xi YANG1, 2, Liang PAN1, Chun-yan GAN1, Li ZHANG1, Ji-yin ZHOU3, *, authorsList=Luo-xi YANG, Liang PAN, Chun-yan GAN, Li ZHANG, Ji-yin ZHOU, authorCompany=null, correspAuthors=Ji-yin ZHOU, 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=1322624486466236712, articleId=1322624485841285413, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=新版《药物临床试验质量管理规范》对主要研究者和临床试验机构的新要求及其应对措施, columnId=1322624486113915175, journalTitle=中国新药杂志, columnName=·2026年版《药物临床试验质量管理规范》解读专题, runingTitle=null, highlight=null, articleAbstract=
目的：

分析新版《药物临床试验质量管理规范》（Good Clinical Practice，GCP）对主要研究者、临床试验机构提出的新要求，探究目前行业所面临的问题及应对策略。

方法:

通过对新版GCP修订条款的深入解读及与2020年版的比较，结合ICH E6（R3）的核心理念，从法律责任界定、试验参与者保护、数据完整性、质量管理体系构建等角度对合规性和现状进行分析。

结果:

确定了主要研究者为“临床试验现场最终责任人”的法律地位，提出临床试验机构应当建立并保证全过程质量管理体系的有效运行。同时，提出了一种智能化管理途径，将数字化工具嵌入管理流程中，以应对技术壁垒、成本投入、认知偏差等现实问题。

结论:

新版GCP的推行意味着我国药物临床试验管理由原来的“形式合规”向“质量源于设计”“基于风险”的转变。主要研究者和临床试验机构应当依靠数字化驱动以及管理范式的协同演进来创建智慧化质量生态，在保证合规性的同时实现临床试验效能的实质飞跃。

, authors=杨洛浠1, 2, 潘亮1, 甘春燕1, 张丽1, 周吉银3, *, authorsList=杨洛浠, 潘亮, 甘春燕, 张丽, 周吉银, authorCompany=null, correspAuthors=周吉银, authorNote=

杨洛浠，女，硕士研究生，主管护师，主要从事临床试验管理及质量控制。E-mail：。

, correspAuthorsNote=

*

周吉银，男，博士研究生，副研究员，主要从事医学伦理研究。E-mail：。
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2 School of Medicine, University of Electronic Science and Technology of China, Chengdu 610054, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322624487279931703, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624485841285413, authorId=1322624487112159539, language=CN, stringName=杨洛浠, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, address=1德阳市人民医院临床试验中心，德阳 618000
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杨洛浠，女，硕士研究生，主管护师，主要从事临床试验管理及质量控制。E-mail：。

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杨洛浠，女，硕士研究生，主管护师，主要从事临床试验管理及质量控制。E-mail：。

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journalId=1235980733773295621, articleId=1322624485841285413, language=CN, orderNo=5, keyword=应对措施)], refs=[Reference(id=1322624491176440151, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624485841285413, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［1］, rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局药品审评中心. 国家药监局药审中心发布《中国新药注册临床试验进展年度报告（2025年）》.(2026-06-22)[2026-07-02].https://www.cde.org.cn/main/news/viewInfoCommon/3c3e3f37c4b56cdd4896ef6 256f5efcb., articleTitle=null, refAbstract=null), Reference(id=1322624491247743320, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624485841285413, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［2］, rfOrder=1, authorNames=null, journalName=null, refType=null, 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新版《药物临床试验质量管理规范》对主要研究者和临床试验机构的新要求及其应对措施
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杨洛浠 1, 2 , 潘亮 1 , 甘春燕 1 , 张丽 1 , 周吉银 3, *
中国新药杂志 | ·2026年版《药物临床试验质量管理规范》解读专题 2026,35(19): 2028-2037
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中国新药杂志 |·2026年版《药物临床试验质量管理规范》解读专题 2026 , 35 (19) : 2028 -2037
新版《药物临床试验质量管理规范》对主要研究者和临床试验机构的新要求及其应对措施
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杨洛浠1, 2 , 潘亮1, 甘春燕1, 张丽1, 周吉银3, *
作者信息
  • 1德阳市人民医院临床试验中心，德阳 618000
  • 2电子科技大学医学院，成都 610054
  • 3陆军军医大学第二附属医院临床医学研究中心，重庆 400037
通讯作者:

*

周吉银，男，博士研究生，副研究员，主要从事医学伦理研究。E-mail：。
作者简介:

杨洛浠，女，硕士研究生，主管护师，主要从事临床试验管理及质量控制。E-mail：。

New requirements and response strategies for principal investigators and clinical trial institutions under the revised Good Clinical Practice guidelines
Luo-xi YANG1, 2 , Liang PAN1, Chun-yan GAN1, Li ZHANG1, Ji-yin ZHOU3, *
Affiliations
  • 1 Clinical Trial Center, Deyang People’s Hospital, Deyang 618000, China
  • 2 School of Medicine, University of Electronic Science and Technology of China, Chengdu 610054, China
  • 3 Clinical Medical Research Center, the Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
出版时间: 2026-10-15 doi: 10.20251/j.cnki.1003-3734.2026.19.002
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摘要
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目的：

分析新版《药物临床试验质量管理规范》（Good Clinical Practice，GCP）对主要研究者、临床试验机构提出的新要求，探究目前行业所面临的问题及应对策略。

方法:

通过对新版GCP修订条款的深入解读及与2020年版的比较，结合ICH E6（R3）的核心理念，从法律责任界定、试验参与者保护、数据完整性、质量管理体系构建等角度对合规性和现状进行分析。

结果:

确定了主要研究者为“临床试验现场最终责任人”的法律地位，提出临床试验机构应当建立并保证全过程质量管理体系的有效运行。同时，提出了一种智能化管理途径，将数字化工具嵌入管理流程中，以应对技术壁垒、成本投入、认知偏差等现实问题。

结论:

新版GCP的推行意味着我国药物临床试验管理由原来的“形式合规”向“质量源于设计”“基于风险”的转变。主要研究者和临床试验机构应当依靠数字化驱动以及管理范式的协同演进来创建智慧化质量生态，在保证合规性的同时实现临床试验效能的实质飞跃。

药物临床试验质量管理规范  /  主要研究者  /  临床试验机构  /  质量管理  /  应对措施
Objective:

To analyze the new requirements imposed on principal investigators and clinical trial institutions by the revised Good Clinical Practice (GCP) guidelines, and to explore the challenges currently facing the industry along with corresponding response strategies.

Methods:

Through an in-depth interpretation of the revised GCP provisions and a comparative analysis with the 2020 version, integrated with the core principles of ICH E6(R3), this study examined compliance and the current status from the perspectives of legal liability delineation, participant protection, data integrity, and quality management system development.

Results:

The legal status of the principal investigator as the “ultimate responsible party at the clinical trial site” was established, and it was proposed that clinical trial institutions should build and ensure the effective operation of a full process quality management system. In addition, an intelligent management pathway was identified, embedding digital tools into management processes to address practical challenges including technical barriers, cost investments, and cognitive biases.

Conclusion:

The implementation of the revised GCP signifies a shift in China’s clinical trial management from the former “compliance oriented” approach toward “quality-by-design” and “risk-based” approaches. Principal investigators and clinical trial institutions should leverage digital transformation and the co-evolution of management paradigms to create an intelligent quality ecosystem, achieving a substantial leap in clinical trial performance while maintaining full regulatory compliance.

Good Clinical Practice  /  principal investigator  /  clinical trial institution  /  quality management  /  response strategies
杨洛浠, 潘亮, 甘春燕, 张丽, 周吉银. 新版《药物临床试验质量管理规范》对主要研究者和临床试验机构的新要求及其应对措施. 中国新药杂志, 2026 , 35 (19) : 2028 -2037 . DOI: 10.20251/j.cnki.1003-3734.2026.19.002
Luo-xi YANG, Liang PAN, Chun-yan GAN, Li ZHANG, Ji-yin ZHOU. New requirements and response strategies for principal investigators and clinical trial institutions under the revised Good Clinical Practice guidelines[J]. Chinese Journal of New Drugs, 2026 , 35 (19) : 2028 -2037 . DOI: 10.20251/j.cnki.1003-3734.2026.19.002
基金
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  • 德阳市科技局重点研发指导类资助项目(2024SZY005)
文献
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2026年第35卷第19期
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文章信息
doi: 10.20251/j.cnki.1003-3734.2026.19.002
  • 接收时间：2026-07-27
  • 首发时间：2026-10-29
  • 出版时间：2026-10-15
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  • 收稿日期：2026-07-27
基金
德阳市科技局重点研发指导类资助项目(2024SZY005)
作者信息
    1德阳市人民医院临床试验中心，德阳 618000
    2电子科技大学医学院，成都 610054
    3陆军军医大学第二附属医院临床医学研究中心，重庆 400037

通讯作者:

*

周吉银，男，博士研究生，副研究员，主要从事医学伦理研究。E-mail：。
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红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
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