Article(id=1322624526882550288, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.19.004, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1783958400000, receivedDateStr=2026-07-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793267860383, onlineDateStr=2026-10-29, pubDate=1791993600000, pubDateStr=2026-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793267860383, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793267860383, creator=13701087609, updateTime=1793267860383, 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=2048, endPage=2054, ext={EN=ArticleExt(id=1322624527125819921, articleId=1322624526882550288, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=New requirements, challenges, and countermeasures of the updated Good Clinical Practice for drug clinical trial data governance in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To analyze the new requirements and challenges in the data governance chapter of China’s 2026 edition of Good Clinical Practice (GCP), and to propose corresponding strategies.

Methods:

This paper systematically summarizes the core provisions in the new GCP, including the full data lifecycle, blinding management, and computerized system standards, and explores of practical implementation challenges in the context of China’s specific circumstances.

Results:

The new GCP faces challenges in China, including inconsistencies between regulatory frameworks and technical standards, great difficulties in the execution of blinding management, imperfect development and validation of computerized systems, and insufficient awareness and capabilities in data governance.

Conclusion:

China’s regulatory requirements for drug clinical trials should further align with international concepts; management mindsets should be adjusted; standard operating procedures should be updated in a timely manner; and coordinated efforts should be made to improve the regulatory framework, optimize blinding processes, promote standardization of computerized systems, and strengthen data governance training and cultural development, so as to establish a scientific and efficient clinical trial data governance system.

, authors=Yi-chao ZHUO1, Hui-qing XU1, Pei-pei LIN1, Ji-yin ZHOU2, *, authorsList=Yi-chao ZHUO, Hui-qing XU, Pei-pei LIN, 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=1322624527373283858, articleId=1322624526882550288, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=新版《药物临床试验质量管理规范》对我国药物临床试验数据治理的新要求、新挑战与对策, 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:

分析我国《药物临床试验质量管理规范》(Good Clinical Practice,GCP)2026年版数据治理章节的新要求、新挑战,并提出应对策略。

方法:

系统归纳新版GCP中的数据全生命周期、盲态管理、计算机化系统规范等核心规定,并结合我国实际情况探讨落地难题。

结果:

新版GCP在我国面临法规与技术标准不统一、盲态管理执行难度大、计算机化系统建设与验证不完善、数据治理意识与能力不足等问题。

结论:

我国药物临床试验监管要求应进一步与国际理念接轨,调整管理思路,及时更新标准操作规程,从完善法规体系、优化盲态流程、推进计算机化系统标准化、加强数据治理培训与文化建设等方面协同施策,构建科学、高效的临床试验数据治理体系。

, authors=卓一超1, 许慧清1, 林培培1, 周吉银2, *, authorsList=卓一超, 许慧清, 林培培, 周吉银, authorCompany=null, correspAuthors=周吉银, authorNote=

卓一超,男,硕士,信息系统项目管理师,主要从事医学伦理审查、信息系统及智能伦理辅助审查系统建设工作。E-mail:。

, correspAuthorsNote=

*

周吉银,男,博士,副研究员,主要从事临床试验管理和医学伦理审查工作。E-mail:。
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卓一超,男,硕士,信息系统项目管理师,主要从事医学伦理审查、信息系统及智能伦理辅助审查系统建设工作。E-mail:。

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卓一超,男,硕士,信息系统项目管理师,主要从事医学伦理审查、信息系统及智能伦理辅助审查系统建设工作。E-mail:。

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ICH《E6(R3): 药物临床试验质量管理规范技术指导原则》变化亮点和主要修订内容[J]. 中国医学伦理学, 2026, 39(5): 557-564., articleTitle=null, refAbstract=null), Reference(id=1322624534679761467, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624526882550288, 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, unstructuredReference=International Councle for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 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新版《药物临床试验质量管理规范》对我国药物临床试验数据治理的新要求、新挑战与对策
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卓一超 1 , 许慧清 1 , 林培培 1 , 周吉银 2, *
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): 2048-2054
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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) : 2048 -2054
新版《药物临床试验质量管理规范》对我国药物临床试验数据治理的新要求、新挑战与对策
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卓一超1 , 许慧清1, 林培培1, 周吉银2, *
作者信息
  • 1温州医科大学附属第一医院,温州 325000
  • 2陆军军医大学第二附属医院,重庆 400037
通讯作者:

*

周吉银,男,博士,副研究员,主要从事临床试验管理和医学伦理审查工作。E-mail:。
作者简介:

卓一超,男,硕士,信息系统项目管理师,主要从事医学伦理审查、信息系统及智能伦理辅助审查系统建设工作。E-mail:。

New requirements, challenges, and countermeasures of the updated Good Clinical Practice for drug clinical trial data governance in China
Yi-chao ZHUO1 , Hui-qing XU1, Pei-pei LIN1, Ji-yin ZHOU2, *
Affiliations
  • 1 The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China
  • 2 The Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
出版时间: 2026-10-15 doi: 10.20251/j.cnki.1003-3734.2026.19.004
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目的:

分析我国《药物临床试验质量管理规范》(Good Clinical Practice,GCP)2026年版数据治理章节的新要求、新挑战,并提出应对策略。

方法:

系统归纳新版GCP中的数据全生命周期、盲态管理、计算机化系统规范等核心规定,并结合我国实际情况探讨落地难题。

结果:

新版GCP在我国面临法规与技术标准不统一、盲态管理执行难度大、计算机化系统建设与验证不完善、数据治理意识与能力不足等问题。

结论:

我国药物临床试验监管要求应进一步与国际理念接轨,调整管理思路,及时更新标准操作规程,从完善法规体系、优化盲态流程、推进计算机化系统标准化、加强数据治理培训与文化建设等方面协同施策,构建科学、高效的临床试验数据治理体系。

药物临床试验质量管理规范  /  数据治理  /  数据生命周期  /  盲态管理  /  计算机化系统
Objective:

To analyze the new requirements and challenges in the data governance chapter of China’s 2026 edition of Good Clinical Practice (GCP), and to propose corresponding strategies.

Methods:

This paper systematically summarizes the core provisions in the new GCP, including the full data lifecycle, blinding management, and computerized system standards, and explores of practical implementation challenges in the context of China’s specific circumstances.

Results:

The new GCP faces challenges in China, including inconsistencies between regulatory frameworks and technical standards, great difficulties in the execution of blinding management, imperfect development and validation of computerized systems, and insufficient awareness and capabilities in data governance.

Conclusion:

China’s regulatory requirements for drug clinical trials should further align with international concepts; management mindsets should be adjusted; standard operating procedures should be updated in a timely manner; and coordinated efforts should be made to improve the regulatory framework, optimize blinding processes, promote standardization of computerized systems, and strengthen data governance training and cultural development, so as to establish a scientific and efficient clinical trial data governance system.

Good Clinical Practice  /  data governance  /  data lifecycle  /  blinded management  /  computerized system
卓一超, 许慧清, 林培培, 周吉银. 新版《药物临床试验质量管理规范》对我国药物临床试验数据治理的新要求、新挑战与对策. 中国新药杂志, 2026 , 35 (19) : 2048 -2054 . DOI: 10.20251/j.cnki.1003-3734.2026.19.004
Yi-chao ZHUO, Hui-qing XU, Pei-pei LIN, Ji-yin ZHOU. New requirements, challenges, and countermeasures of the updated Good Clinical Practice for drug clinical trial data governance in China[J]. Chinese Journal of New Drugs, 2026 , 35 (19) : 2048 -2054 . DOI: 10.20251/j.cnki.1003-3734.2026.19.004
  • 2022年陆军军医大学人文社会科学基金重点资助项目(2022XRW02)
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2026年第35卷第19期
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doi: 10.20251/j.cnki.1003-3734.2026.19.004
  • 接收时间:2026-07-14
  • 首发时间:2026-10-29
  • 出版时间:2026-10-15
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  • 收稿日期:2026-07-14
基金
2022年陆军军医大学人文社会科学基金重点资助项目(2022XRW02)
作者信息
    1温州医科大学附属第一医院,温州 325000
    2陆军军医大学第二附属医院,重庆 400037

通讯作者:

*

周吉银,男,博士,副研究员,主要从事临床试验管理和医学伦理审查工作。E-mail:。
参考文献
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小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
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