Article(id=1291704950715868033, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.20.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1751558400000, receivedDateStr=2025-07-04, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896058967, onlineDateStr=2026-08-05, pubDate=1761580800000, pubDateStr=2025-10-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896058967, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896058967, creator=13701087609, updateTime=1785896058967, updator=13701087609, issue=Issue{id=1291704786705993936, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='20', pageStart='2851', pageEnd='3000', issueExtLink='null', onlineDate='null', pubDate='1761580800000', pubDateStr='2025-10-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896019864, creator='13701087609', updateTime=1785896741492, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707813508702571, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707813508702572, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2982, endPage=2987, ext={EN=ArticleExt(id=1291704950908806018, articleId=1291704950715868033, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Common issues and improvement measures in quality management of clinical trial institution, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
Objective To conduct a systematic analysis of the issues identified during routine quality control of clinical trials, investigate the root causes of quality problems in the trial implementation process, and explore improvement measures to enhance quality.
Methods Issues identified in 255 routine quality control activities across 142 clinical trials from February 2023 to May 2025 were collected. These issues were categorized, aggregated, and subjected to statistical analysis.
Results A total of 248 issues were identified. These were primarily concentrated at the trial implementation level, specifically: 77 (31.05%) pertained to essential document management, 74 (29.84%) to the standardization of source records, 25 (10.08%) to the proper execution of informed consent forms, 23 (9.27%) to the completeness of source data, and 15 (6.05%) to the completeness of researcher credentials. Analysis of the causes indicated that these problems were mainly associated with ineffective researcher training, lack of active participation from investigators, deficiencies in the management and training of clinical research coordinators (CRCs), and insufficient quality control practices within specialty teams.
Conclusion The institution exhibits a prominent proportion of issues related to essential document management and the standardization of source records. To reduce the occurrence of these problems and improve clinical trial quality, it is necessary to strengthen researcher training, enhance engagement, standardize CRC management, and improve the effectiveness of quality control within specialty teams.
, authors=Xin FENG, Yan LI, Bao-shun LI, Yi-bo ZHOU, Xin-hai JIANG, Jin WANG, Chao-ying HU, authorsList=Xin FENG, Yan LI, Bao-shun LI, Yi-bo ZHOU, Xin-hai JIANG, Jin WANG, Chao-ying HU, authorCompany=null, correspAuthors=Chao-ying HU, 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=1291704951282099075, articleId=1291704950715868033, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=临床试验机构质量管理中的常见问题和改进措施, 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 对某机构临床试验日常质控中发现的问题进行系统分析，剖析临床试验实施过程中质量问题的成因，并探讨提升临床试验质量的改进措施。
方法 收集某机构2023年2月至2025年5月对142个临床试验项目开展255次日常质控中发现的问题，对问题进行分类汇总统计分析。
结果 日常质控共发现问题248个，主要集中在临床试验实施层面：其中必备文件管理方面77个（31.05%）、原始记录规范性方面74个（29.84%）、知情同意签署规范性方面25个（10.08%）、原始数据完整性方面23个（9.27%）、研究人员资料完整性方面15个（6.05%）。分析问题成因，主要与研究人员培训效果不佳、参与积极性不足、临床研究协调员（CRC）管理与培训欠缺、专业组质控工作不扎实等因素有关。
结论 该机构在必备文件管理和原始记录规范性方面发现的问题占比突出，需通过强化研究人员培训、提高参与积极性、规范CRC管理、提升专业组质控实效性，减少问题发生，提高临床试验质量。
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冯鑫（1979-），女，主要从事临床研究质量评价及管理方面的工作
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