Department of Clinical Pharmacology and Clinical Pharmacy, National University of Pharmacy, 27 Pushkinska street, Kharkiv, 61057, Ukraine.
Department of Chemical and Pharmaceutical Disciplines, MIHE «Rivne Medical Academy», Rivne, Ukraine.
Ther Innov Regul Sci. 2022 Sep;56(5):814-821. doi: 10.1007/s43441-022-00428-7. Epub 2022 Jul 2.
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.
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.
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.
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.
临床研究专业人员核心能力的定义需求已得到广泛认可。2014 年，联合工作组（Sonstein 等人，JAMA 28（3）：17-23，2014）提出了核心能力框架之后，全球范围内的许多研究人员和从业者已经对其进行了测试和实施，而乌克兰直到最近才开始实施。
我们对乌克兰的临床研究从业者进行了调查，了解他们对 Sonstein 等人（JAMA 28（3）：17-23，2014）提出的能力领域的自我评估，测试了他们的 GCP 知识，评估了他们的教育水平和手段，以及拓宽教育工具范围以达到核心能力框架建议标准的必要性。
我们确定了四个能力领域的能力问题：药物开发和监管、数据管理和信息学、科学概念和研究设计以及研究和站点管理。我们的研究还确定，大多数乌克兰临床研究专业人员参加的短期 GCP 培训不足以在所有领域提供全面的能力。
发现的知识差距为拓宽乌克兰临床研究专业人员的教育工具范围提供了证据；我们建议开设长期学术项目，其课程基于核心能力框架。
