Article(id=1322127449572364828, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1633622400000, acceptedDateStr=2021-10-08, onlineDate=1793149347917, onlineDateStr=2026-10-28, pubDate=1640793600000, pubDateStr=2021-12-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793149347917, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793149347917, creator=13701087609, updateTime=1793149347917, updator=13701087609, issue=Issue{id=1322127420036071763, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='24', pageStart='2225', pageEnd='2327', issueExtLink='null', onlineDate='null', pubDate='1640793600000', pubDateStr='2021-12-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793149340876, creator='13701087609', updateTime=1793149575427, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128403881374295, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128403881374296, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2288, endPage=2294, ext={EN=ArticleExt(id=1322127449832411677, articleId=1322127449572364828, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Thoughts and recommendations arising from a review of “subcenter contracts” for clinical research initiated by investigators, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The “subcenter contract” is the basis of multi-center research initiated by investigators. It is a crucial contract document for agreeing on the mutual power and responsibilities of the various institutions participating in the study. This paper analyzed the general characteristics of 158 subcenter contracts for investigator initiated trials (IIT) and assessed the common problems. All the 158 IIT subcenter contracts were in Chinese text, most contracts were signed with university affiliated hospitals and prefecture-level hospitals, most contracts were signed with oncology hospitals and general hospitals, and most of the contracts adopted unified templates of the leading units. Among the 40 template contracts, the common problems were as follows: 45.9% of the contracts did not mention the way of providing research drugs, 51.3% did not specify the adverse drug reaction monitoring and reporting responsibilities during the study, 60% did not mention the subject damage liability, 50% did not state who were responsible for data preservation after the end of the study, misplacement of the regulations that IIT should follow or refer to, missing or unclear key elements of the contract, unclear responsibility for clinical research and supervision, etc. According to the above analysis results, this paper respectively put forward thoughts and suggestions on the legal and regulatory basis to be followed by IIT, the provision of research drugs, adverse reaction monitoring report, the confidentiality and preservation of research data, intellectual property sharing, subject damages, and the key elements of research contract.

, authors=Ye CAO¹, Li-ying QIN², Hui JIANG³, Shuang-zhen CHEN⁴, Can LI⁵, Ting LIN⁶, Jing-min ZHANG⁴, Pan WANG⁷, authorsList=Ye CAO, Li-ying QIN, Hui JIANG, Shuang-zhen CHEN, Can LI, Ting LIN, Jing-min ZHANG, Pan WANG, authorCompany=null, correspAuthors=null, 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=1322127450079875614, articleId=1322127449572364828, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=从研究者发起的临床研究“分中心合同”审查引发的思考和建议, columnId=1236331741447778310, journalTitle=中国新药杂志, columnName=药物临床试验规范与进展专栏, runingTitle=null, highlight=null, articleAbstract=

“分中心合同”是研究者发起的多中心研究开展的基础，是约定参与研究的各家机构相互权责的重要契约文件。本文通过对某医院2010年1月至2020年12月期间受理的158份研究者发起的临床研究（investigator initiated trial，IIT）分中心合同进行回顾分析，总结归纳分中心合同的一般特征及审查常见问题。158份IIT分中心合同均为中文文本，以高校附属医院和地市级医院为主，以肿瘤专科医院和综合医院为主，采用牵头单位统一模板为主。40份模板合同中，常见问题表现为：45.9%的IIT项目未提及研究药物的提供方式，51.3%的IIT合同未明确研究期间的药品不良反应监测和报告职责，60%的合同未提及受试者损害赔偿责任，50%的合同并未明确研究结束后的资料保存责任方，合同中对IIT应遵循或参考的法规表述错位、合同关键要素缺失或表述不明确、临床研究监查责任不明确等。本文分别对IIT需遵循的法律法规依据、研究药物的提供方式、不良反应监测报告、研究资料的保密和保存、知识产权分享、受试者损害赔偿、研究合同的关键要素等提出了思考和建议。

, authors=曹烨¹, 秦丽英², 蒋辉³, 陈双珍⁴, 李粲⁵, 林婷⁶, 张靖敏⁴, 王盼⁷, authorsList=曹烨, 秦丽英, 蒋辉, 陈双珍, 李粲, 林婷, 张靖敏, 王盼, authorCompany=null, correspAuthors=null, authorNote=, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=a0GxJ6vf/SLSqIc0FLvGgg==, magXml=MOpcvDRyRoZRO/nRDymUyg==, pdfUrl=null, pdf=tRuSBRaMzs8t4pQay3Se0w==, pdfFileSize=3016307, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=s5nuzUA8UVqUrzwGTxVRmg==, mapNumber=null, fund=null)}, authors=[Author(id=1322127450973262389, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127449572364828, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=caoye@sysucc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322127451052954167, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127449572364828, authorId=1322127450973262389, language=EN, stringName=Ye CAO, firstName=Ye, middleName=null, lastName=CAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹Department of Clinical Research, Sun Yat-sen University Cancer Hospital, Guangzhou 510060, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322127451149423160, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127449572364828, authorId=1322127450973262389, language=CN, stringName=曹烨, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹中山大学附属肿瘤医院临床研究部，广州　510060, bio={"content":"

曹烨，女，医学博士，助理研究员，主要从事临床研究设计与管理、药物临床试验安全性评价研究。联系电话：(020)87343826，E-mail：caoye@sysucc.org.cn。

"}, bioImg=null, bioContent=

曹烨，女，医学博士，助理研究员，主要从事临床研究设计与管理、药物临床试验安全性评价研究。联系电话：(020)87343826，E-mail：caoye@sysucc.org.cn。

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