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Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical
V Ye Dobrova1, O S Popov2, O V Shtrimaitis3
1Department of Clinical Pharmacology and Clinical Pharmacy, National University of Pharmacy, 27 Pushkinska street, Kharkiv, 61057, Ukraine.
Ukrainian clinical research professionals need more comprehensive training. Current Good Clinical Practice (GCP) education is insufficient to meet core competency standards, necessitating new educational approaches.
Area of Science:
- Clinical Research
- Professional Development
- Medical Education
Background:
- Core competencies for clinical research professionals are globally recognized.
- The Joint Task Force proposed a Core Competency Framework in 2014.
- Ukraine has recently begun implementing this framework.
Purpose of the Study:
- Assess self-assessed competencies of Ukrainian clinical research practitioners.
- Evaluate Good Clinical Practice (GCP) knowledge and educational levels.
- Determine the need for enhanced educational tools to meet framework standards.
Main Methods:
- Survey of Ukrainian clinical research practitioners.
- Assessment of competency domains from Sonstein et al. (2014).
- Evaluation of GCP knowledge and current educational methods.
Main Results:
- Identified competence gaps in Medicines Development and Regulation, Data Management and Informatics, Scientific Concepts and Research Design, and Study and Site Management.
- Short-term GCP trainings are inadequate for comprehensive competence.
- Most Ukrainian professionals have limited training in core competency domains.
Conclusions:
- Significant knowledge gaps exist among Ukrainian clinical research professionals.
- Current educational approaches, primarily short-term GCP training, are insufficient.
- A long-term academic program based on the Core Competence Framework is recommended.
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