Article(id=1322624503948104372, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.19.009, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1777305600000, receivedDateStr=2026-04-28, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793267854916, onlineDateStr=2026-10-29, pubDate=1791993600000, pubDateStr=2026-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793267854916, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793267854916, creator=13701087609, updateTime=1793267854916, 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=2082, endPage=2089, ext={EN=ArticleExt(id=1322624504103293621, articleId=1322624503948104372, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Architecture design and application exploration of an intelligent quality control system for new traditional chinese medicine drug clinical trials from an institutional perspective, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

AbstractIn response to the limitations of the traditional quality control (QC) model for clinical trials of new traditional Chinese medicine (TCM) drugs, this paper explores the construction of a full-process intelligent QC system centered on artificial intelligence (AI) technology. From the perspective of clinical trial institutions, by integrating currently relatively mature AI technologies, this paper proactively plans QC application scenarios for clinical trials of new TCM drugs and proposes an intelligent QC system architecture covering the entire process before, during, and after the trial. It focuses on elaborating the framework, module composition, main functions, key technical features, and implementation pathways of the intelligent QC system, including data security, management of drugs and biospecimens, protocol evaluation and start-up preparation, intelligent screening and recruitment, risk monitoring and early warning, data governance and quality assessment, and knowledge accumulation and mining. The clinical trial QC system deeply integrated with AI technology can enable institutions to achieve a paradigm shift in QC, shifting from passive response to active prevention and from post-hoc verification to real-time monitoring, thereby improving the quality and efficiency of clinical trials.

, authors=Wan-zhong SHI¹, Yi-hui HU¹, Yi-chen ZHOU¹, Xi-yi ZHANG¹, Cheng-bin XU¹, Ping XU¹, Liu YANG², Lei-lei ZHU^{1, *}, Wei-an YUAN^{1, *}, authorsList=Wan-zhong SHI, Yi-hui HU, Yi-chen ZHOU, Xi-yi ZHANG, Cheng-bin XU, Ping XU, Liu YANG, Lei-lei ZHU, Wei-an YUAN, authorCompany=null, correspAuthors=Lei-lei ZHU, Wei-an YUAN, 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=1322624504392700598, articleId=1322624503948104372, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=基于机构视角的中药新药临床试验智能质控系统架构设计与应用探索, 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=

针对中药新药临床试验传统质控模式的局限，探索以人工智能（artificial intelligence, AI）技术为核心的全流程智能化质控系统的构建。基于临床试验机构视角，通过整合目前相对成熟的AI技术，前瞻性地规划面向中药新药临床试验的质控应用场景，提出了智能质控系统架构，覆盖“试验前-试验中-试验后”全流程。重点阐述了智能质控系统框架、模块组成、主要功能、关键技术特点与实现路径，涵盖数据安全、药物与生物样本管理、方案评估与启动准备、智能筛选与招募、风险监控与预警、数据治理和质量评估、知识沉淀与挖掘等环节。深度融合AI技术的临床试验质控系统，可助力机构实现从被动响应到主动预防、从事后核查到实时监控的质控范式转变，提升临床试验质量与效率。

, authors=史万忠¹, 胡薏慧¹, 周一辰¹, 张习艺¹, 徐铖斌¹, 徐平¹, 羊柳², 朱蕾蕾^{1, *}, 元唯安^{1, *}, authorsList=史万忠, 胡薏慧, 周一辰, 张习艺, 徐铖斌, 徐平, 羊柳, 朱蕾蕾, 元唯安, authorCompany=null, correspAuthors=朱蕾蕾, 元唯安, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=R7nFt8nog+w2+I+Pqx2c2A==, magXml=h7Dz0qrIJDo3r96au1FlLQ==, pdfUrl=null, pdf=lD4m+JYCPQ3CTindI8qOLQ==, pdfFileSize=1271099, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=QuAXhXsJN5vjvYvqe1E14A==, mapNumber=null, fund=null)}, authors=[Author(id=1322624504824713918, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624503948104372, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=shwzh@hotmail.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322624504921182912, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624503948104372, authorId=1322624504824713918, language=EN, stringName=Wan-zhong SHI, firstName=Wan-zhong, middleName=null, lastName=SHI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=1 Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322624505026040513, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624503948104372, authorId=1322624504824713918, language=CN, stringName=史万忠, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹上海中医药大学附属曙光医院，上海 201203, bio={"content":"

史万忠，男，博士，主任药师，研究方向：中药制剂与临床评价。E-mail：shwzh@hotmail.com。

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史万忠，男，博士，主任药师，研究方向：中药制剂与临床评价。E-mail：shwzh@hotmail.com。

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