Article(id=1291707025591914697, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.21.025, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1747152000000, receivedDateStr=2025-05-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896553656, onlineDateStr=2026-08-05, pubDate=1763308800000, pubDateStr=2025-11-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896553656, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896553656, creator=13701087609, updateTime=1785896553656, updator=13701087609, issue=Issue{id=1291706987964822180, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='21', pageStart='3001', pageEnd='3150', issueExtLink='null', onlineDate='null', pubDate='1763308800000', pubDateStr='2025-11-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896544684, creator='13701087609', updateTime=1785896721343, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707729324826977, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707729324826978, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3147, endPage=3150, ext={EN=ArticleExt(id=1291707027529683147, articleId=1291707025591914697, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=A cross-sectional survey of vocational training needs and status of clinical research coordinators in China, columnId=1291707027399659722, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Management of Clinical Trial Institution, runingTitle=null, highlight=null, articleAbstract=
Objective To investigate and analyze the current state of professional training for clinical research coordinators (CRCs), explore the differences in CRC cultivation between clinical trial institutions and site management organizations (SMOs), and provide references for optimizing the CRC training system.
Methods A total of 613 active CRCs was conducted using convenience sampling method and quota sampling method. The questionnaire includes basic information, induction teaching methods, training frequency, training content, training satisfaction and training needs, etc. Data were collected by the ‘questionnaire star’, statistically analyzed using SAS 9.3 software, and differences were compared using the chi-square test.
Results There were significant differences between institutions and SMO companies in the education, professional background and working years of CRC (All P<0.05). Institutional CRC generally has a higher degree and more nursing background, while SMO company CRC contains a certain proportion of people with non-medical background. In terms of training, institutional CRC prefers moderate frequency training (6 to 12 times per year), while SMO CRC prefers more frequent high frequency training (more than 12 times per year). SMO company has a high utilization rate of online training, and institutional CRC has some deficiencies in communication skills training. Overall, the CRC is relatively satisfied with the existing training system.
Conclusion Institutions and SMO companies should develop reasonable training plans according to their own characteristics and reduce unnecessary training burden to improve the work efficiency and clinical trial quality of CRC. It is recommended to adopt more offline training forms, and to conduct targeted training according to the individual needs of CRC.
, authors=Jian-cai WU, Meng-meng WANG, Jing-wen XU, Wan-qing JI, authorsList=Jian-cai WU, Meng-meng WANG, Jing-wen XU, Wan-qing JI, authorCompany=null, correspAuthors=Jian-cai WU, 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=1291707027869421773, articleId=1291707025591914697, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=一项中国临床研究协调员职业培训需求与现状的横断面调查, columnId=1291707027647123660, journalTitle=中国临床药理学杂志, columnName=临床试验机构管理, runingTitle=null, highlight=null, articleAbstract=
目的 本研究旨在调查和分析临床研究协调员(CRC)的职业培养现状,探讨临床试验机构与临床试验机构协作管理组织(SMO)在CRC培养方面的差异,为优化CRC培训体系提供参考。
方法 用便利抽样法和配额抽样法对613名在职CRC进行问卷调查。问卷内容包括基本资料、入职带教方式、培训频率、培训内容、培训满意度及培训需求等。数据通过“问卷星”收集,用SAS 9.3软件进行统计分析,用卡方检验比较组间差异。
结果 机构和SMO公司在CRC的学历、专业背景及工作年限比较,在统计学上差异均有统计学意义(均P<0.05)。机构CRC普遍具有更高的学历和更多的护理学背景,而SMO公司CRC则包含一定比例的非医药背景人员。在培训方面,机构CRC更倾向于中等频率的培训(每年6~12次),而SMO公司CRC则更倾向于高频率培训(每年12次以上)。SMO公司对线上培训使用率较高,机构CRC在沟通技巧培训方面存在一定不足。总体而言,CRC对现有培训体系较为满意。
结论 机构和SMO公司应根据自身特点制定合理的培训计划,减少不必要的培训负担,以提高CRC的工作效率和临床试验质量。建议多采用线下培训形式,并根据CRC的个体需求进行针对性培训。
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