摘要
目的:构建一套科学客观的能力评价体系,用于评估临床研究协调员(clinical research coordinator,CRC)在临床研究中的能力水平。方法:通过本中心既往的项目管理工作经验及文献回顾,确定CRC临床研究能力的评估指标,结合临床试验开展流程和项目质控结果,搭建CRC的评价体系,并将该评价体系应用于CRC在临床研究中实际工作能力的评估,验证评价体系的客观性、科学性以及可行性。结果:该评价体系结果与既往人工评估结果一致,年资和学历影响临床研究能力。结论:该评价体系能够科学客观地反映CRC的临床研究能力,为CRC的职业发展和管理层的决策提供理论基础。
Objective:To construct a scientific and objective competency evaluation system for assessing the capability level of clinical research coordinators(CRCs)in clinical trials.Methods:Based on previous project management experience of the center and literature review,the evaluation indicators for CRCs' clinical research capabilities were determined.Combining the process of clinical trial implementation and project quality control results,a CRC evaluation system was established.This system was applied to evaluate the practical work capabilities of CRCs in clinical research to verify its objectivity,scientificity,and feasibility.Results:The results of this evaluation system were consistent with previous manual assessment results.Years of practice and educational background were found to influence clinical research capabilities.Conclusion:The evaluation system can scientifically and objectively reflect the clinical research capabilities of CRCs,providing a theoretical basis for CRCs' career development and decision-making by managers.
作者
江旻
刘晓红
赵淑华
沈婉丽
黄珺
梅昀
高盼君
JIANG Min;LIU Xiao-hong;ZHAO Shu-hua;SHEN Wan-li;HUANG Jun;MEI Yun;GAO Pan-jun(State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers,Beijing Key Laboratory of Carcinogenesis&Translational Research,National Drug Clinical Trial Center,Peking University Cancer Hospital&Institute,Beijing 100142,China;Key Laboratory of Carcinogenesis&Translational Research(Ministry of Education/Beijing),National Drug Clinical Trial Center,Peking University Cancer Hospital&Institute,Beijing 100142,China;Yidu Tech Inc,Beijing 100101,China)
出处
《中国新药杂志》
北大核心
2026年第2期172-176,共5页
Chinese Journal of New Drugs
基金
北京市自然科学基金资助项目-海淀原始创新(L232032)
首都卫生发展科研专项资助项目(2022-2Z-2153)。
关键词
临床研究协调员
能力
评价体系
clinical research coordinators
competency
evaluation system
