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Article(id=1292130491726062506, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.07.024, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1771948800000, receivedDateStr=2026-02-25, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997515851, onlineDateStr=2026-08-06, pubDate=1776355200000, pubDateStr=2026-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997515851, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997515851, creator=13701087609, updateTime=1785997515851, updator=13701087609, issue=Issue{id=1292130366320562708, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='7', pageStart='901', pageEnd='1050', issueExtLink='null', onlineDate='null', pubDate='1776355200000', pubDateStr='2026-04-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997485952, creator='13701087609', updateTime=1786014433453, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201449350516861, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201449350516862, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1046, endPage=1050, ext={EN=ArticleExt(id=1292130493437338539, articleId=1292130491726062506, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Key points and risk prevention strategies in contract review for investigator initiated trial, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
Objective

Investigator initiated trial (IIT) contracts serve as critical legal documents defining the rights and responsibilities of all parties involved in clinical research. This study systematically analyzed issues identified during the review of IIT contracts at a medical institution, explored the underlying causes, and proposed targeted risk prevention and control measures.

Methods

A retrospective analysis was conducted on IIT contracts reviewed at a medical institution from January and December 2025. Common issues identified during contract review were summarized and categorized. Distribution patterns and contributing factors were systematically examined.

Results

A total of 96 IIT contracts were reviewed and 917 issue instances were identified. These issues were primarily categorized as follows: legal rights and responsibilities (36.86%, 338 cases/917 cases), protection of research participants’ rights and ethics (6.22%, 57 cases/917 cases), resources and funding management (17.78%, 163 cases/917 cases), data and intellectual property (20.72%, 190 cases/917 cases) and risks associated with human genetic resources (18.43%, 169 cases/917 cases). These issues posed potential risks for medical disputes, commercial bribery, and administrative penalties. Consequently, this study proposed core risk prevention strategies including defining key stakeholder responsibilities, strengthening participant protection, optimizing the management of research funding and conflicts of interest, establishing robust frameworks for intellectual property protection and data privacy, and enforcing strict oversight of human genetic resources.

Conclusion

IIT contracts management requires strengthened review of key elements and establishment of a comprehensive contract management system. The findings provide a practical reference for medical institutions to optimize IIT contract management, thereby supporting the high quality development of clinical research.

, authors=Jing-yao WEI1, Su-ke SUN1, Xiao-yun WANG1, Lu-yao FENG1, Lin LI2, Xin TIAN1, Fu-wei WANG3, authorsList=Jing-yao WEI, Su-ke SUN, Xiao-yun WANG, Lu-yao FENG, Lin LI, Xin TIAN, Fu-wei WANG, authorCompany=null, correspAuthors=Fu-wei WANG, 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=1292130493672219564, articleId=1292130491726062506, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=研究者发起的临床研究合同审查要点及风险防控, 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

研究者发起的临床研究（IIT）合同是约定参与研究各方权责的重要契约文件，本文系统分析了某医疗机构IIT合同审查发现问题，剖析问题成因并提出针对性风险防控措施。

方法

采用回顾性分析方法，选取某医疗机构2025年1月至12月审查的IIT合同，汇总归纳审查常见问题，系统性分析问题分布特征并剖析成因。

结果

共96份IIT合同纳入研究，共发现917例次问题，主要表现在法律与权责（36.86%，338例次/917例次）、研究参与者权益保护与伦理（6.22%，57例次/917例次）、资源与经费（17.78%，163例次/917例次）、数据与知识产权（20.72%，190例次/917例次）、人类遗传资源风险（18.43%，169例次/917例次）方面，可引发医患纠纷、商业贿赂、行政处罚等风险。鉴于此，本文从明确各方关键性权责、加强研究参与者权益保护、健全研究经费和利益冲突管理、构建知识产权保护与数据隐私保密体系、严格人类遗传资源管理等多维度提出合同风险防控的核心策略。

结论

IIT合同管理需强化关键环节的审核，构建合同管理体系。本研究结果可为医疗机构IIT合同管理实践提供参考和指引，保障临床研究高质量发展。

, authors=魏静瑶1, 孙素珂1, 王肖雲1, 冯璐瑶1, 李霖2, 田鑫1, 王福伟3, authorsList=魏静瑶, 孙素珂, 王肖雲, 冯璐瑶, 李霖, 田鑫, 王福伟, authorCompany=null, correspAuthors=王福伟, authorNote=

魏静瑶（1992-），女，主管药师，主要从事临床研究质量评价及管理方面工作

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王福伟，研究员 Tel: （0371）66295651 E-mail:
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研究者发起的临床研究合同审查要点及风险防控
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魏静瑶 1 , 孙素珂 1 , 王肖雲 1 , 冯璐瑶 1 , 李霖 2 , 田鑫 1 , 王福伟 3
中国临床药理学杂志 | 临床试验管理专栏 2026,42(7): 1046-1050
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中国临床药理学杂志 |临床试验管理专栏 2026 , 42 (7) : 1046 -1050
研究者发起的临床研究合同审查要点及风险防控
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魏静瑶（1992-），女，主管药师，主要从事临床研究质量评价及管理方面工作

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魏静瑶1, 孙素珂1, 王肖雲1, 冯璐瑶1, 李霖2, 田鑫1, 王福伟3
作者信息
  • 1.郑州大学第一附属医院临床研究中心 河南 郑州 450000
  • 2.郑州大学第一附属医院审计处 河南 郑州 450000
  • 3.郑州大学第一附属医院 河南 郑州 450000
通讯作者:
王福伟，研究员 Tel: （0371）66295651 E-mail:
作者简介:

魏静瑶（1992-），女，主管药师，主要从事临床研究质量评价及管理方面工作

Key points and risk prevention strategies in contract review for investigator initiated trial
Jing-yao WEI1, Su-ke SUN1, Xiao-yun WANG1, Lu-yao FENG1, Lin LI2, Xin TIAN1, Fu-wei WANG3
Affiliations
  • 1.Clinical Research Center, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, Henan Province, China
  • 2.Audit Office, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, Henan Province, China
  • 3.The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, Henan Province, China
出版时间: 2026-04-17 doi: 10.13699/j.cnki.1001-6821.2026.07.024
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摘要
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目的

研究者发起的临床研究（IIT）合同是约定参与研究各方权责的重要契约文件，本文系统分析了某医疗机构IIT合同审查发现问题，剖析问题成因并提出针对性风险防控措施。

方法

采用回顾性分析方法，选取某医疗机构2025年1月至12月审查的IIT合同，汇总归纳审查常见问题，系统性分析问题分布特征并剖析成因。

结果

共96份IIT合同纳入研究，共发现917例次问题，主要表现在法律与权责（36.86%，338例次/917例次）、研究参与者权益保护与伦理（6.22%，57例次/917例次）、资源与经费（17.78%，163例次/917例次）、数据与知识产权（20.72%，190例次/917例次）、人类遗传资源风险（18.43%，169例次/917例次）方面，可引发医患纠纷、商业贿赂、行政处罚等风险。鉴于此，本文从明确各方关键性权责、加强研究参与者权益保护、健全研究经费和利益冲突管理、构建知识产权保护与数据隐私保密体系、严格人类遗传资源管理等多维度提出合同风险防控的核心策略。

结论

IIT合同管理需强化关键环节的审核，构建合同管理体系。本研究结果可为医疗机构IIT合同管理实践提供参考和指引，保障临床研究高质量发展。

研究者发起的临床研究  /  合同审查  /  风险防控
Objective

Investigator initiated trial (IIT) contracts serve as critical legal documents defining the rights and responsibilities of all parties involved in clinical research. This study systematically analyzed issues identified during the review of IIT contracts at a medical institution, explored the underlying causes, and proposed targeted risk prevention and control measures.

Methods

A retrospective analysis was conducted on IIT contracts reviewed at a medical institution from January and December 2025. Common issues identified during contract review were summarized and categorized. Distribution patterns and contributing factors were systematically examined.

Results

A total of 96 IIT contracts were reviewed and 917 issue instances were identified. These issues were primarily categorized as follows: legal rights and responsibilities (36.86%, 338 cases/917 cases), protection of research participants’ rights and ethics (6.22%, 57 cases/917 cases), resources and funding management (17.78%, 163 cases/917 cases), data and intellectual property (20.72%, 190 cases/917 cases) and risks associated with human genetic resources (18.43%, 169 cases/917 cases). These issues posed potential risks for medical disputes, commercial bribery, and administrative penalties. Consequently, this study proposed core risk prevention strategies including defining key stakeholder responsibilities, strengthening participant protection, optimizing the management of research funding and conflicts of interest, establishing robust frameworks for intellectual property protection and data privacy, and enforcing strict oversight of human genetic resources.

Conclusion

IIT contracts management requires strengthened review of key elements and establishment of a comprehensive contract management system. The findings provide a practical reference for medical institutions to optimize IIT contract management, thereby supporting the high quality development of clinical research.

investigator initiated trial  /  contract review  /  risk prevention and control
魏静瑶, 孙素珂, 王肖雲, 冯璐瑶, 李霖, 田鑫, 王福伟. 研究者发起的临床研究合同审查要点及风险防控. 中国临床药理学杂志, 2026 , 42 (7) : 1046 -1050 . DOI: 10.13699/j.cnki.1001-6821.2026.07.024
Jing-yao WEI, Su-ke SUN, Xiao-yun WANG, Lu-yao FENG, Lin LI, Xin TIAN, Fu-wei WANG. Key points and risk prevention strategies in contract review for investigator initiated trial[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (7) : 1046 -1050 . DOI: 10.13699/j.cnki.1001-6821.2026.07.024
基金
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  • 郑州大学党风廉政专题研究基金资助项目(2025DFLZ-14)
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doi: 10.13699/j.cnki.1001-6821.2026.07.024
  • 接收时间：2026-02-25
  • 首发时间：2026-08-06
  • 出版时间：2026-04-17
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  • 收稿日期：2026-02-25
基金
郑州大学党风廉政专题研究基金资助项目(2025DFLZ-14)
作者信息
    1.郑州大学第一附属医院临床研究中心 河南 郑州 450000
    2.郑州大学第一附属医院审计处 河南 郑州 450000
    3.郑州大学第一附属医院 河南 郑州 450000

通讯作者:

王福伟，研究员 Tel: （0371）66295651 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.07.024
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2种不同金属材料的力学参数
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species		 占总种数比例
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total species (%)		 属
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species		 占总种数比例
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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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