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. 2022 Sep;56(5):814-821.
doi: 10.1007/s43441-022-00428-7. Epub 2022 Jul 2.

Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals

V Ye Dobrova  1 , O S Popov  2 , O V Shtrimaitis  3 , O O Andreeva  1 , O M Proskurnia  4
Affiliations

Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals

V Ye Dobrova et al. Ther Innov Regul Sci. 2022 Sep.

Abstract

Background: The need to define core competencies for clinical research professionals has been widely recognized. And after the Joint Task Force have proposed Core Competency Framework in 2014 (Sonstein et al. in JAMA 28(3):17-23, 2014), it has been tested and implemented by a variety of researchers and practitioners worldwide, while Ukraine avoided implementing this until recently.

Methods: We surveyed Ukrainian-based clinical research practitioners on their self-assessment in the competency domains proposed by Sonstein et al. (JAMA 28(3):17-23, 2014), tested their GCP knowledge, assessed their level and means of education, and the need to broaden the range of educational tools to reach the standards suggested by the Core Competency Framework.

Results: We identified competence issues in four competence domains: Medicines Development and Regulation, Data Management and Informatics, Scientific Concepts and Research Design, and Study and Site Management. Our study also determined that short-term GCP trainings, attended by most of Ukrainian-based clinical research professionals, are insufficient to provide thorough competence in all domains.

Conclusions: The identified knowledge gaps provide evidence for the need to broaden the range of educational tools for Ukrainian-based clinical research professionals; we suggest launching long-term academic program with its curriculum based on the Core Competence Framework.

Keywords: Clinical research competence domains; Clinical research professionals; Clinical trials; Professional development; Self-assessment; Survey.

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