• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2026, Vol. 43 ›› Issue (1): 74-74-76.doi: 10.2095-3593.2026.030010

• 管理研究 • 上一篇    下一篇

临床研究协调员培训的探索与思考

  宦静, 倪琪*   

  1. 中国医学科学院皮肤病医院, 江苏 南京 210042
  • 收稿日期:2025-11-07 修回日期:2025-12-22 接受日期:2026-04-01 出版日期:2026-02-28 发布日期:2026-04-01
  • 基金资助:
    北京协和医学院“中央高校基本科研业务费”项目(3332023111)

Exploration and Reflection on the Training of Clinical Research Coordinators

 HUAN Jing, NI Qi*   

  1. Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Jiangshu Nanjing 210042, China
  • Received:2025-11-07 Revised:2025-12-22 Accepted:2026-04-01 Online:2026-02-28 Published:2026-04-01

摘要: 临床研究协调员作为临床试验实施过程中的关键角色,其专业能力直接影响试验质量和数据可靠性。本研究通过系统分析我国临床研究协调员培训现状,发现存在培训体系不完善、培训供给与需求存在差距、临床研究协调员参加培训的主观能动性不足和工作负荷高等四大突出问题。针对上述问题,本研究提出:应建立行业统一的培训认证体系;临床试验现场管理组织应建立成熟适用的培训体系;探索多样化、互动性强的培训方式和建立持续性的专业培训和职业发展路径。建议通过监管部门、行业协会和企业的多方协作,为规范临床研究协调员执业资格认证和优化培训体系提供理论依据和实践参考。

关键词: font-size:medium, ">临床研究协调员;培训;现状;建议

Abstract: As a key role in the implementation of clinical trials, the professional competence of clinical research coordinators (CRC) directly affects the quality of trials and the reliability of data. This study, through a systematic analysis of the current training situation of clinical research coordinators in China, found that there are four prominent problems: an imperfect training system, a gap between training supply and demand, insufficient subjective initiative in participating in training, and high workload. To address these problems, this study proposes that a unified training and certification system for the industry should be established, site management organizations (SMOs) should set up mature and applicable training systems, diverse and highly interactive training methods should be explored, and continuous professional training and career development paths should be established. It is suggested that through the multi-party collaboration of regulatory authorities, industry associations and enterprises, theoretical basis and practical reference be provided for standardizing the professional qualification certification of clinical research coordinators and optimizing the training system.

Key words: font-size:medium, "> , Clinical research coordinator; Training; Current situation; Suggestion

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