Multi-Regional Clinical Trials Center, 14 Story Street, 4th Floor, Cambridge, MA, 02138, USA.
Duke Office of Research Initiatives, Duke University, Durham, NC, USA.
Ther Innov Regul Sci. 2020 Jan;54(1):1-20. doi: 10.1007/s43441-019-00024-2. Epub 2020 Jan 6.
Competency standards for clinical research professionals are being developed across the enterprise, based largely on the Core Competency Framework put forth by the Joint Task Force for Clinical Trial Competency (JTF). In late 2016, representatives from organizations around the world convened at a workshop hosted by the Multi-Regional Clinical Trial Center of Brigham and Women's Hospital and Harvard (MRCT Center) to discuss their use of the standards. A number of modifications were suggested that resulted in the publication of JTF Framework 2.0. Another suggested evolution of the Framework was to consider "leveling" the competencies, to reflect the increase in competency that occurs as individuals progress in their careers. This paper describes the process utilized and final outcome of this work. The leveled competencies, defined as the Fundamental, Skilled, and Advanced levels, and the included examples are expected to provide better-defined tools and resources to organizations that are creating educational and training programs, standardized role descriptions, or professional progression planning for clinical research professionals.
正在全企业范围内制定临床研究专业人员的能力标准，主要基于临床试验能力联合工作组（JTF）提出的核心能力框架。2016 年末，来自世界各地的组织代表在布莱根妇女医院和哈佛的多区域临床试验中心（MRCT 中心）主办的研讨会上齐聚一堂，讨论他们对这些标准的使用情况。提出了一些修改建议，最终形成了 JTF 框架 2.0。该框架的另一个建议发展是考虑“分级”能力，以反映个人职业发展中能力的提高。本文描述了该工作所使用的过程和最终结果。分级能力定义为基础、熟练和高级三个级别，以及包含的示例，预计将为正在为临床研究专业人员创建教育和培训计划、标准化角色描述或职业发展规划的组织提供更好定义的工具和资源。
