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 JIANG1, Hong ZHANG2, Hu CHEN3, Jian LI1, 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。

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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

, correspAuthorsNote=
李剑,研究员,博士生导师 MP: 13979107989 E-mail:
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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
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蒋小燕 1 , 张红 2 , 陈虎 3 , 李剑 1
中国临床药理学杂志 | 读者园地 2025,41(9): 1315-1318
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中国临床药理学杂志 |读者园地 2025 , 41 (9) : 1315 -1318
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
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蒋小燕1, 张红2, 陈虎3, 李剑1
作者信息
  • 1.南昌大学 第二附属医院 临床试验研究中心,江西 南昌 330006
  • 2.江西省肿瘤医院 临床医学研究中心,江西 南昌 330006
  • 3.沧州市中心医院 医务部,河北 沧州 061001
通讯作者:
李剑,研究员,博士生导师 MP: 13979107989 E-mail:
作者简介:

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

Preliminary exploration of the construction of a qualification evaluation system for primary investigators in clinical trials based on the Delphi method
Xiao-yan JIANG1, Hong ZHANG2, Hu CHEN3, Jian LI1
Affiliations
  • 1.Clinical Trial Research Centre, The Second Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China
  • 2.Clinical Research Centre, Jiangxi Provincial Cancer Hospital, Nanchang 330006, Jiangxi Province, China
  • 3.Medical Department, Cangzhou Central Hospital, Cangzhou 061001, Hebei Province, China
出版时间: 2025-05-17 doi: 10.13699/j.cnki.1001-6821.2025.09.020
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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。

主要研究者  /  临床试验  /  评估体系  /  德尔菲法
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.

principal investigator  /  clinical trial  /  evaluation system  /  Delphi method
蒋小燕, 张红, 陈虎, 李剑. 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. 中国临床药理学杂志, 2025 , 41 (9) : 1315 -1318 . DOI: 10.13699/j.cnki.1001-6821.2025.09.020
Xiao-yan JIANG, Hong ZHANG, Hu CHEN, Jian LI. Preliminary exploration of the construction of a qualification evaluation system for primary investigators in clinical trials based on the Delphi method[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (9) : 1315 -1318 . DOI: 10.13699/j.cnki.1001-6821.2025.09.020
  • 江西省重点研发计划“揭榜挂帅”基金资助项目(20223BBG71006)
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2025年第41卷第9期
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doi: 10.13699/j.cnki.1001-6821.2025.09.020
  • 接收时间:2024-12-23
  • 首发时间:2026-08-04
  • 出版时间:2025-05-17
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  • 收稿日期:2024-12-23
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江西省重点研发计划“揭榜挂帅”基金资助项目(20223BBG71006)
作者信息
    1.南昌大学 第二附属医院 临床试验研究中心,江西 南昌 330006
    2.江西省肿瘤医院 临床医学研究中心,江西 南昌 330006
    3.沧州市中心医院 医务部,河北 沧州 061001

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李剑,研究员,博士生导师 MP: 13979107989 E-mail:
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2种不同金属材料的力学参数

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属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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