摘要
目的构建适合我国研究者发起的临床研究(IIT)协调员(CRC)核心胜任力的评价指标体系。方法通过文献检索、专家访谈及"洋葱模型"构建体系框架;通过"德尔菲专家咨询法"确定指标体系;通过"层次分析法"确定各指标权重。结果构建的CRC胜任力评价体系包括:知识背景(0.1430)、岗位技能(0.3008)、职业素养(0.4839)和人文特质(0.0723)4个一级指标、18个二级指标和49个三级指标;第三轮咨询各级指标重要性评分平均值>3.5,权威系数=0.86,变异系数<0.3,肯德尔协调系数为0.183~0.366(P<0.001);各层级指标权重单排序一致性比率CR<0.1,整体排序CR=0.0437,具有逻辑可靠性。结论本研究构建的CRC核心胜任力评价指标体系有较强的科学性,能为医疗机构中开展IIT的研究者筛选符合要求、专业素养可靠的CRC提供评价工具。
ObjectiveThis study aims to construct an evaluation index system suitable for the core competency of Clinical Research Coordinators(CRCs)in Investigator-Initiated Trials(IITs)in China.MethodsThis study developed a system framework through the Onion Model,literature research,and expert interviews,utilized the Delphi method to build the index system.and analyzed the weight of each indicator through the Analytic Hierarchy Process(AHP).ResultsFour first-level indicators were basic knowledge(0.143),job skills(0.3008),professional quality(0.4839),and personality traits(0.0723).Besides,18 second-level indicators and 49 third-level indicators were developed through the Delphi method.According to the third round expert′s consultation,the average scores of all indexes were>3.50,the authoritative coefficient was 0.86,the coefficient of variation of each index was<0.30,and Kendall coefficients of concordance were 0.183~0.366(P<0.001).The consistency ratios of single-sort were<0.1,and the overall sort of all indexes was 0.0437,which showed good logical reliability.ConclusionsThis evaluation index system for Clinical Research Coordinators is of great scientific sense.It provides IIT-conducting investigators in institutions with a proficient assessment tool to help them find qualified and reliable CRCs.
作者
谢贤
陈凌燕
董文渊
史文涛
许锋
Xie Xian;Chen Lingyan;Dong Wenyuan;Shi Wentao;Xu Feng(Clinical Research Center,Shanghai Ninth People′s Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China;Department of Discipline Planning,Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China)
出处
《中华医学科研管理杂志》
2025年第1期13-20,共8页
Chinese Journal of Medical Science Research Management
基金
上海交通大学医学院附属第九人民医院2023年度医院管理研究项目(YGA202302)。
作者简介
通信作者:许锋,Email:xufenghhou@163.com,电话:021-53315789。
