Article(id=1292126474081948205, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.02.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1762185600000, receivedDateStr=2025-11-04, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996557970, onlineDateStr=2026-08-06, pubDate=1769529600000, pubDateStr=2026-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996557970, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996557970, creator=13701087609, updateTime=1785996557970, updator=13701087609, issue=Issue{id=1292126409196064779, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1769529600000', pubDateStr='2026-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996542500, creator='13701087609', updateTime=1786014671444, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292202447569707674, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292202447569707675, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=285, endPage=290, ext={EN=ArticleExt(id=1292126474476212782, articleId=1292126474081948205, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Research and practice of clinical trial intelligent information system, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
Objective To develop a clinical trial management system (CTMS) to realize full-process review and management of clinical trial projects, research team management, document management, subject management, drug sample management, free medical order management and quality management.
Methods Within the framework of the existing hospital information system, we collaborated with the hospital information center and a commercial software company to design and develop a full-process intelligent information system for clinical trials. Based on WebService, the system was connected to the hospital information system through standardized application programming interfaces (APIs), with the establishment of standard data dictionaries and governance rules to achieve secure data exchange between heterogeneous systems.
Results The system balanced development costs and functionality, and achieved good application effects. It integrated functions including project process, document management, drug sample management, subject management, free inspection and testing, and quality management, formed a medical database covering the entire project cycle of subjects, and ensured the authenticity and traceability of data.
Conclusion This system fully leverages the advantages of joint development and informatization, improves the enrollment efficiency and implementation quality of clinical trials, and provides reference experience for other hospitals to implement integrated clinical trial management systems.
, authors=Lei JI, Jun-long CAI, Jing-jing ZHOU, Dao-qin SUN, Jian-ying HUANG, authorsList=Lei JI, Jun-long CAI, Jing-jing ZHOU, Dao-qin SUN, Jian-ying HUANG, authorCompany=null, correspAuthors=Jian-ying HUANG, 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=1292126474987917871, articleId=1292126474081948205, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=临床试验全流程智能信息系统研究与实践, columnId=1291704889869103713, journalTitle=中国临床药理学杂志, columnName=临床试验管理专栏, runingTitle=null, highlight=null, articleAbstract=
目的 开发临床试验全流程智能信息系统（CTMS），实现对临床试验项目各流程审查管理、研究团队管理、资料管理、受试者管理、药品样本管理、免费医嘱管理及质量管理。
方法 在现有医院信息系统框架内，联合医院信息中心与某商业软件公司，设计并开发临床试验全流程智能信息系统，基于网络服务（WebService），通过标准化应用程序编程接口（API）与医院信息系统对接，建立标准化数据字典与规则，实现异构系统间安全的数据交换。
结果 本系统兼顾开发成本与功能性，使用效果良好，整合了项目流程、文档管理、药品样本、受试者管理、免费检查检验及质量管理等功能，形成了受试者全项目周期的医疗数据库，数据真实可溯源。
结论 本系统充分发挥了联合开发与信息化的优势，提升了临床试验的入组效率与实施质量，为其他医院实施一体化临床试验管理系统提供了可借鉴的经验。
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纪磊（1993-），男，工程师，从事临床试验项目审查与信息化建设的研究和工作
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