Article(id=1292135446541267765, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.11.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1774886400000, receivedDateStr=2026-03-31, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998697170, onlineDateStr=2026-08-06, pubDate=1781625600000, pubDateStr=2026-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998697170, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998697170, creator=13701087609, updateTime=1785998697170, updator=13701087609, issue=Issue{id=1292135402790482407, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1781625600000', pubDateStr='2026-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1785998686739, creator='13701087609', updateTime=1786014315540, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292200954833686587, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292200954833686588, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1640, endPage=1646, ext={EN=ArticleExt(id=1292135447237522230, articleId=1292135446541267765, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Research on the evaluation of training effectiveness for clinical investigators based on the competency model, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
Objective Based on the previously established competency model for clinical investigators in drug clinical trials, this study aims to evaluate the effectiveness of a targeted training program, clarify the role of this model in improving investigators’ professional competence, operational skills, and ethical awareness, and provide evidence-based basis for the precise optimization of clinical trial training models.
Methods Investigators from tertiary Grade A hospitals in Beijing who had participated in at least one clinical trial in the past three years were selected as the research subjects. The training content was designed based on the core elements of the competency model. A pre-training and post-training paired design was adopted to evaluate the improvement of knowledge and skills through standardized Good Clinical Practice (GCP) simulation tests; online questionnaire surveys were conducted to collect trainees’ satisfaction feedback on training content, teaching quality, organizational management and other dimensions. Wilcoxon signed-rank test was used to compare scores before and after training. Stratified by gender, the Mann-Whitney U test was used to compare the inter-group differences in post-training competency scores of investigators of different genders. Stratified by educational background, professional title and working years of clinical trial practice, the Kruskal-Wallis H test was adopted to analyze the inter-group differences in post-training scores among investigators with different educational levels, different professional titles, and different working years.
Results A total of 81 clinical investigators were included, with a median age of 34 (31.00, 44.00) years. The proportions of males and females were 27.16% and 72.84%, respectively. Among the participants, 62.96% held doctoral degrees, and 32.10% had senior professional titles. The median pre-training total score (Q1, Q3) was 35.00 (31.00, 39.00) scores, while the median post-training total score (Q1, Q3) was 43.00 (40.00, 46.00) scores, indicating a significant improvement in the trainees’ total scores (Z=-7.30, P<0.001). The scores for all competency sub-dimensions increased significantly compared to those before training. Among them, the differences in scores before and after training for ethical awareness and subject protection, GCP implementation capability, study design and protocol execution, and data quality control were all statistically significant (all P<0.001). Subgroup analysis showed that the total competency scores of investigators with different genders, professional titles, and years of experience in clinical trials significantly improved after training, with no statistically significant differences in the magnitude of improvement between groups. Participants with master’s or doctoral degrees showed significant improvements in post-training scores (all P<0.001), while those with bachelor’s degrees showed no significant difference between pre- and post-training scores (P>0.05). Furthermore, 85.19% of the trainees rated the overall performance of the training as very satisfied.
Conclusion The training program designed based on the competency model could improve the GCP theoretical level and practical knowledge reserve of clinical investigators in clinical trials, and has good trainee acceptance and practicality. By accurately matching the core competency needs of clinical investigators, this training model provides a replicable practical path for the optimization of the clinical trial talent training system.
, authors=Shuang ZHAO, Hui-qing YAO, Juan WANG, Xin WANG, authorsList=Shuang ZHAO, Hui-qing YAO, Juan WANG, Xin WANG, authorCompany=null, correspAuthors=Xin 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=1292135448424510264, articleId=1292135446541267765, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于胜任力模型的药物临床试验医生培训效果评价研究, 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 基于前期构建的药物临床试验研究医生胜任力模型，评估针对性培训方案的实施效果，明确该模型在提升研究医生专业素养、操作技能及伦理意识等方面的作用，为临床试验培训模式的精准优化提供循证依据。
方法 选取近3年参与过至少1项临床试验的北京市三甲医院研究医生为研究对象，依据胜任力模型中的核心要素设计培训内容。用“培训前-培训后”配对设计，通过标准化药物临床试验质量管理规范（GCP）模拟测试评估知识与技能提升效果；结合在线问卷调研收集学员对培训内容、授课质量、组织管理等维度的满意度反馈。培训前后成绩比较用Wilcoxon符号秩检验。按性别分层，用Mann-Whitney U检验比较不同性别研究医生培训后胜任力得分的组间差异。按学历、职称及从业年限分层，分别用Kruskal-Wallis H检验，分析不同学历层次、不同职称等级以及不同从业年限研究医生培训后得分的组间差异。
结果 本研究共有81名研究医生参与了培训。年龄中位数为34（31.00，44.00）岁；男性和女性的比例分别为27.16%（22例/81例）和72.84%（59例/81例）。62.96%（51例/81例）的培训对象具有博士学历，32.10%（26例/81例）的培训对象为高级职称。培训前总分为35.00（31.00，39.00）分，培训后总分为43.00（40.00，46.00）分，培训提高了培训对象的总分（Z=-7.30，P<0.001）。各胜任力分项维度得分均较培训前显著提升，其中伦理意识与受试者保护、GCP实施能力、研究设计与方案执行、数据质量控制维度培训前后得分对比，在统计学上差异均有统计学意义（均P<0.001）。亚组分析显示，不同性别、职称及临床试验工作年限的研究医生培训后胜任力总分均显著提升，且组间培训提升幅度在统计学上差异均无统计学意义（均P>0.05）；仅学历亚组中，硕士、博士学历人员培训后得分均显著提升（均P<0.001），本科学历人员培训前后得分在统计学上差异无统计学意义（P>0.05）。85.19%的培训对象对本次培训的整体表现给予了“非常满意”的评价。
结论 基于胜任力模型设计的培训方案可提升临床试验研究医生的GCP理论水平与实践相关知识储备，且具备良好的学员接受度与实用性。该培训模式通过精准匹配研究医生的核心能力需求，为临床试验人才培养体系的优化提供了可复制的实践路径。
, authors=赵爽, 姚慧卿, 王娟, 王欣, authorsList=赵爽, 姚慧卿, 王娟, 王欣, authorCompany=null, correspAuthors=王欣, authorNote=
赵爽（1993-），女，助理研究员，主要从事临床试验方法学与统计学、临床试验质量管理、研究者胜任力评价及规范化培训体系建设的研究和工作
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