Article(id=1291404944846876904, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404875351449891, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.09.020, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1734883200000, receivedDateStr=2024-12-23, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824531995, onlineDateStr=2026-08-04, pubDate=1747411200000, pubDateStr=2025-05-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824531995, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824531995, creator=13701087609, updateTime=1785824531995, updator=13701087609, issue=Issue{id=1291404875351449891, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='9', pageStart='1201', pageEnd='1350', issueExtLink='null', onlineDate='null', pubDate='1747411200000', pubDateStr='2025-05-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824515426, creator='13701087609', updateTime=1785824515426, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1315, endPage=1318, ext={EN=ArticleExt(id=1291404945010454761, articleId=1291404944846876904, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Preliminary exploration of the construction of a qualification evaluation system for primary investigators in clinical trials based on the Delphi method, columnId=1246531412438966969, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Reader’s Field, runingTitle=null, highlight=null, articleAbstract=
Objective To establish a qualification evaluation system for primary investigators (PI) in clinical trials.
Methods Based on the preliminary determination of PI qualification evaluation indicators in accordance with laws and regulations, 19 experts engaged in clinical trials or clinical trial management fields were selected for 2 rounds of Delphi expert consultation, and the weights of each indicator were calculated using principal component analysis.
Results The positive coefficients for the two rounds of expert consultation were 100.00% and 94.74%, and the expert authority coefficients were 0.940 and 0.933, the coordination coefficients of expert opinions were 0.318 and 0.613. After 2 rounds of expert consultation, the PI qualification evaluation indicators were determined, including 3 primary indicators and 17 secondary indicators. The results of principal component analysis showed that the weight range of each index was 0.037 9 to 0.080 3.
Conclusion The preliminary construction of the PI qualification evaluation system based on the "PI Qualification Evaluation Form" has strong scientificity and applicability, and can provide references for the evaluation and selection of clinical trial PI.
, authors=Xiao-yan JIANG
1, Hong ZHANG
2, Hu CHEN
3, Jian LI
1, authorsList=Xiao-yan JIANG, Hong ZHANG, Hu CHEN, Jian LI, authorCompany=null, correspAuthors=Jian LI, 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=1291404945253724394, articleId=1291404944846876904, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于德尔菲法初步探讨临床试验主要研究者资质评估体系的构建, columnId=1246531414020219657, journalTitle=中国临床药理学杂志, columnName=读者园地, runingTitle=null, highlight=null, articleAbstract=
目的 构建临床试验主要研究者(PI)资质评估体系。
方法 基于法律法规初步确定PI资质评估指标,遴选19名从事临床试验或临床试验管理领域的专家进行2轮德尔菲法专家咨询,用主成分分析法计算各指标权重。
结果 第1、2轮专家咨询积极系数分别为100.00%和94.74%,专家权威系数分别为0.940和0.933,专家意见协调系数分别为0.318和0.613。经过2轮专家咨询确定PI资质评估指标,包括3个一级指标、17个二级指标。主成分分析结果显示,各指标权重范围0.037 9~0.080 3。
结论 基于《PI资质评估表》初步构建的PI资质评估体系,有较强的科学性、适用性,可为临床试验PI的评估与选择提供参考依据。
, authors=蒋小燕
1, 张红
2, 陈虎
3, 李剑
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蒋小燕(1991-),女,实习研究员,主要从事临床试验管理的相关工作
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