Leveling the Joint Task Force Core Competencies for Clinical Research Professionals.
Stephen A SonsteinRebecca J Namenek BrouwerWilliam GluckH Robert KolbCarmen AldingerBarbara E BiererCarolynn Thomas JonesPublished in: Therapeutic innovation & regulatory science (2020)
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.
Keyphrases
- clinical trial
- medical education
- global health
- nursing students
- public health
- open label
- phase ii
- study protocol
- double blind
- polycystic ovary syndrome
- acute care
- healthcare
- randomized controlled trial
- pregnant women
- type diabetes
- adipose tissue
- emergency department
- phase iii
- pregnancy outcomes
- electronic health record