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中国医药导刊 ›› 2022, Vol. 24 ›› Issue (5): 517-520.

• 管理与实践 • 上一篇    下一篇

美国临床研究协调员核心胜任力指南及对我国的启示

   王天阳1, 王欣2, 姚文兵1*   

  1. 1.中国药科大学, 江苏 南京 210000; 2. 北京医院/国家老年医学中心/中国医学科学院 老年医学研究院 临床试验研究中心, 北京 100730
  • 收稿日期:2022-05-17 修回日期:2022-03-01 出版日期:2022-05-28 发布日期:2022-05-28
  • 基金资助:
    十三五国家科技重大新药创制专项课题项目(项目编号:2017ZX09304026001;项目名称:临床试验研究支撑平台建设)

Core Competency Guidelines for Clinical Research Coordinators in the United States and Its Inspiration to China

  1. 1. China Pharmaceutical University, Jiangsu Nanjing 210000, China; 2.Beijing Hospital/National Center of Gerontology/Chinese Academy of Medical Sciences, Institute of Geriatric Medicine, Clinical Trial Centre, Beijing 100730, China
  • Received:2022-05-17 Revised:2022-03-01 Online:2022-05-28 Published:2022-05-28
  • Contact: YAO WenBing E-mail:wbyao@cpu.edu.cn

摘要: 临床研究协调员(CRC)在整个临床试验开展过程中发挥着重要作用,CRC的能力水平对临床试验质量具有积极意义。因此制定CRC管理制度、建立培训体系和完善晋升机制在CRC行业发展中至关重要。为借鉴和学习美国临床研究专业学会(ACRP)最新发布的CRC核心胜任力指南,本研究对科学概念、伦理和受试者安全、研究产品的开发和监管、临床研究操作、研究和现场管理、数据管理和信息学、领导力和职业素养、沟通和团队合作8个模块不同级别(初级、中级和高级)CRC的胜任力要素进行梳理,分析了CRC胜任力指南制定的意义,提出CRC胜任力指南制定有助于对CRC的能力进行多维度评估并开发相应的培训体系,建议我国应构建CRC胜任力指南模型,明确CRC行业规范和资质认证标准,规范CRC职位描述、发展和绩效考核,评估CRC能力,促进CRC行业标准制定和规范化发展,协助申办方和临床试验机构选任和管理CRC。

关键词: font-size:medium, ">临床研究协调员;胜任力;药物临床试验

Abstract: The level of clinical research coordinator (CRC) competency is critical to the quality of clinical trials. This study introduces the latest core competency guidelines for CRC issued by the Association of Clinical Research Professionals(ACRP),which provide an overview of CRC competency at different levels from eight domains: scientific concepts, ethical and participant safety concerns, investigational products development and regulation, clinical study operations, study and site management, data management and informatics, leadership and professionalism, communication and teamwork. The development of CRC competency guidelines facilitates multi-dimensional assessment of CRC’s competency and the development of appropriate training systems. It is recommended to build a model of CRC competency guidelines in China, promote the development of industry standards on CRC and its standardized development, and assist sponsors and clinical trial institutions in selecting and managing CRC.

Key words: Clinical Research Coordinator, Competency, Clinical trail

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