Article(id=1292135438471422620, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1774886400000, receivedDateStr=2026-03-31, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998695247, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998695247, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998695247, creator=13701087609, updateTime=1785998695247, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1485, endPage=1500, ext={EN=ArticleExt(id=1292135438744052381, articleId=1292135438471422620, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Expert consensus on key points of the Beijing DCT project management system documents, columnId=1291704959951725493, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Expert Consensus, runingTitle=null, highlight=null, articleAbstract=

Currently, decentralized clinical trials (DCT) are in a period of rapid development, with new technologies and methods such as remote intelligent technologies, wearable devices, and electronic data capture systems continuously emerging, profoundly reshaping the traditional clinical trial landscape. To adapt to this transformative trend and promote the scientific and orderly implementation of DCT in Beijing, the "Beijing Municipal Medical Products Administration", in collaboration with ten pilot institutions, has developed the "Beijing DCT Project Management System Document Consensus" through in-depth practice and multiple rounds of discussion. This consensus, consisting of 15 management documents, establishes a standardized management framework characterized by clear roles and responsibilities, operational feasibility, and controllable quality. It represents a significant milestone in the modernization of clinical trial governance in Beijing and has formed a replicable "Beijing Experience".

, authors=Ruo-wei TANG¹, Xin WANG², Yu-ying YIN², Yan CUI³, Min JIANG⁴, Xiao-yuan CHEN⁵, Shu-min WANG⁶, Ying GAO⁷, Zhen-wei XIE⁸, Xiao-hong HAN⁹, Ping DU¹⁰, Yu TANG¹¹, Hong FANG¹¹, Zhi-xia ZHAO¹², Tong GUO¹³, Ya-dong ZHANG¹, Yi-min CUI¹⁴, authorsList=Ruo-wei TANG, Xin WANG, Yu-ying YIN, Yan CUI, Min JIANG, Xiao-yuan CHEN, Shu-min WANG, Ying GAO, Zhen-wei XIE, Xiao-hong HAN, Ping DU, Yu TANG, Hong FANG, Zhi-xia ZHAO, Tong GUO, Ya-dong ZHANG, Yi-min CUI, authorCompany=null, correspAuthors=Ya-dong ZHANG, Yi-min CUI, 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=1292135439050236574, articleId=1292135438471422620, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=北京市DCT项目管理体系文件要点专家共识, columnId=1291704960111109047, journalTitle=中国临床药理学杂志, columnName=专家共识, runingTitle=null, highlight=null, articleAbstract=

当前，去中心化临床试验（DCT）正处于蓬勃发展期，远程智能技术、可穿戴设备、电子数据采集系统等新技术与新方法不断涌现，深刻重塑着传统临床试验的形态。为顺应这一变革趋势，推动本市DCT科学有序落地，北京市药品监督管理局组织10家试点机构，经过深入实践与多轮研讨，形成了覆盖DCT全流程、全要素的《北京市DCT项目管理体系文件共识》。本共识由15项管理文件组成，构建了权责明晰、操作可行、质量可控的标准化管理框架，是本市临床试验治理现代化的重要标志，形成了可复制推广的“北京经验”。

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