Article(id=1292126376786682780, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.04.020, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1768838400000, receivedDateStr=2026-01-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996534773, onlineDateStr=2026-08-06, pubDate=1772208000000, pubDateStr=2026-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996534773, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996534773, creator=13701087609, updateTime=1785996534773, updator=13701087609, issue=Issue{id=1292126355785802497, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1772208000000', pubDateStr='2026-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996529766, creator='13701087609', updateTime=1786014519902, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201811952292026, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201811952292027, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=581, endPage=585, ext={EN=ArticleExt(id=1292126377134810013, articleId=1292126376786682780, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Inspection perspectives on drug clinical trial institutions and investigators’ quality management practices in clinical trials, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

The drug clinical trial institution serves as the management entity for the trial site and the responsible unit for protecting the rights and interests of the subjects. The investigator is responsible for the quality of clinical trials and the rights and safety of subjects at the clinical trial site. The depth and precision of quality management in both aspects determine the reliability of the trials data and the level of safety and rights protection for the subjects. This study introduced the quality management requirements and inspection focus of relevant regulations for drug clinical trial institutions and investigators from the perspective of inspection. Meanwhile, this study analyzed reasons and provided suggestions based on relevant risks identified during the inspection, with the aim of offering reference for conductors and supervisors of drug clinical trials.

, authors=Yuan WANG, Hong WANG, Rong GAO, authorsList=Yuan WANG, Hong WANG, Rong GAO, authorCompany=null, correspAuthors=Rong GAO, 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=1292126377533268894, articleId=1292126376786682780, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=从检查视角浅析药物临床试验机构和研究者在临床试验中的质量管理, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

药物临床试验机构作为试验现场的管理主体和受试者权益保护的责任主体，研究者作为对临床试验质量及受试者权益和安全负责的试验现场的负责人，2者质量管理的深度与精度决定了试验数据的可靠性及受试者安全和权益保障水平。本文从检查视角出发，梳理对药物临床试验机构及研究者的质量管理法规要求与检查关注重点，结合近年检查实践中识别出的风险进行分析并提出建议，以期为药物临床试验的管理者、实施者提供参考。

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王元（1983-），主管药师，主要从事药物GCP检查管理工作

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王元（1983-），主管药师，主要从事药物GCP检查管理工作

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