Article(id=1322180328807060006, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180288214577608, 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=1618934400000, acceptedDateStr=2021-04-21, onlineDate=1793161955309, onlineDateStr=2026-10-28, pubDate=1630252800000, pubDateStr=2021-08-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161955309, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161955309, creator=13701087609, updateTime=1793161955309, updator=13701087609, issue=Issue{id=1322180288214577608, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='16', pageStart='1441', pageEnd='1536', issueExtLink='null', onlineDate='null', pubDate='1630252800000', pubDateStr='2021-08-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161945632, creator='13701087609', updateTime=1793162101003, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322180940143644721, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180288214577608, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322180940147839026, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180288214577608, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1503, endPage=1508, ext={EN=ArticleExt(id=1322180328991609383, articleId=1322180328807060006, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of the safety reporting requirements of drug clinical trial institutions in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To summarize and analyze the current situation of safety reporting requirements of drug clinical trial institutions in China after the implementation of the new “Good Clinical Practice” (GCP).
Methods: Data processing and statistical analysis were conducted on the reporting procedures and management requirements of safety events issued by 98 drug clinical trial institutions.
Results: Fifty institutions (51.0%) required investigators to submit suspected unexpected serious adverse reactions (SUSAR) to ethics committees. A high proportion of institutions did not specify the media and time limit for SUSAR submission. There were 36 (36.7%) institutions that differentiated the time limit for SUSAR submission from sponsors to at least one role of investigators, ethics or trial management departments. The time limit for SUSAR at own hospitals was shorter than that from other hospitals and 7 or 15 d was the most common time limit. Forty-two (42.9%) institutions required investigators to report severe adverse events (SAE) to ethics committees and/or trial management departments.
Conclusion: Drug clinical trial institutions have timely updated the safety reporting requirements which focus on SUSAR and other safety events at own hospitals. It is necessary to further improve the clarity and convenience of safety reporting procedures and explore the management mechanism of safety events at the institution level.
, authors=Da-wei WU
1, An-qi YU
1, Zhao YAN
2, Wen-na CHEN
3, Yue-long GU
3, Hui-yao HUANG
1, Hong FANG
1, Hui WANG
1, Qi-yu TANG
1, Zhen-gang XU
1, Yu TANG
1, Ning LI
1, authorsList=Da-wei WU, An-qi YU, Zhao YAN, Wen-na CHEN, Yue-long GU, Hui-yao HUANG, Hong FANG, Hui WANG, Qi-yu TANG, Zhen-gang XU, Yu TANG, Ning LI, authorCompany=null, correspAuthors=Ning 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=1322180329260044840, articleId=1322180328807060006, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=我国药物临床试验机构安全性报告要求的现状分析, 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=
目的： 总结分析我国药物临床试验机构在新版《药物临床试验质量管理规范》（GCP）实施后安全性报告要求现状。
方法： 对全国98家药物临床试验机构公开发布的药物临床试验安全性事件报告程序和管理要求进行数据处理和统计分析。
结果： 50家（51.0%）机构要求以研究者作为主要递交方向伦理委员会递交可疑且非预期严重不良反应（suspected unexpected serious adverse reaction，SUSAR）报告，未明确申办方SUSAR报告递交媒介和时限要求的机构比例较高；36家（36.7%）机构对申办者向研究者、伦理或试验管理部门至少一方递交本院和外院SUSAR报告的时限进行区分，本院SUSAR报告递交时限较外院更短，在有明确时限要求的机构中7或15 d是最常见的时限要求；42家（42.9%）机构要求研究者向伦理和/或试验管理部门至少一方上报严重不良事件（severe adverse event，SAE）。
结论： 国内药物临床试验机构能够及时更新安全性报告要求，将SUSAR报告等本院安全性事件作为关注重点，现阶段有必要进一步提升安全性报告程序的清晰性、便利性，探索机构层面安全性事件管理机制。
, authors=吴大维
1, 于安琪
1, 阎昭
2, 陈文娜
3, 古月龙
3, 黄慧瑶
1, 房虹
1, 王辉
1, 汤骐羽
1, 徐震纲
1, 唐玉
1, 李宁
1, authorsList=吴大维, 于安琪, 阎昭, 陈文娜, 古月龙, 黄慧瑶, 房虹, 王辉, 汤骐羽, 徐震纲, 唐玉, 李宁, authorCompany=null, correspAuthors=李宁, authorNote=
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1National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180330048574006, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, authorId=1322180329864024627, language=CN, stringName=吴大维, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院，北京 100021, bio={"content":"
吴大维，男，主治医师，主要从事肿瘤临床试验和伦理审查研究。E-mail：wumingshi-117@163.com。
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吴大维，男，主治医师，主要从事肿瘤临床试验和伦理审查研究。E-mail：wumingshi-117@163.com。
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1国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院，北京 100021, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322180329545257513, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, xref=1, ext=[AuthorCompanyExt(id=1322180329557840426, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, companyId=1322180329545257513, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China), AuthorCompanyExt(id=1322180329566229035, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, companyId=1322180329545257513, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院，北京 100021)])]), Author(id=1322180330337980989, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322180330421867071, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, authorId=1322180330337980989, language=EN, stringName=Zhao YAN, firstName=Zhao, middleName=null, lastName=YAN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
2, address=
2Continuing Education and Science & Technology Service Department of China Anti-Cancer Association, Tianjin 300384, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180330509947456, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, authorId=1322180330337980989, language=CN, stringName=阎昭, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2中国抗癌协会继续教育与科技服务部，天津 300384, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322180329641726508, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, xref=2, ext=[AuthorCompanyExt(id=1322180329654309421, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, companyId=1322180329641726508, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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2中国抗癌协会继续教育与科技服务部，天津 300384)])]), Author(id=1322180330610610754, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322180330698691140, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, authorId=1322180330610610754, language=EN, stringName=Wen-na CHEN, firstName=Wen-na, middleName=null, lastName=CHEN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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3Guangzhou Jeeyor Medical Research Co., Ltd., Guangzhou 510805, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180330774188613, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, authorId=1322180330610610754, language=CN, stringName=陈文娜, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180332821008975, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, authorId=1322180331067789900, language=CN, stringName=黄慧瑶, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院，北京 100021, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322180329545257513, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, xref=1, ext=[AuthorCompanyExt(id=1322180329557840426, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180328807060006, companyId=1322180329545257513, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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