In an effort to prepare the next generation of investigators to conduct clinical and translational research, CTSA training programs have taken the lead to create an educational environment that will define the discipline of clinical and translational science. The overall goal is to create competency-based educational curricula for training clinician-scientists in clinical and translational science.
NCATS, in collaboration with the CTSA Education and Career Development Key Function Committee, formed the Education Core Competency Work Group to define the training standards for core competencies in clinical and translational research. The work group’s final recommendations for core competencies include 14 thematic areas that should shape the training experiences of junior investigators by defining the skills, attributes, and knowledge that can be shared across multidisciplinary teams of clinician-scientists.
- Core competencies for Clinical and Translational Research
- Special Interest Competencies which include competencies for:
- Pediatric Translational Research
- Special Considerations for T1 Research
- Academia-Industry Drug Development
- Medical Device Innovation & Technology Transfer
Clinical Research Professional Core Competencies
The Enhancing Clinical Research Professionals’ Training and Qualifications project adopted the Joint Task Force Core Competencies to develop competency standards targeting principal investigators and clinical research coordinators.
The eight competency domains:
- Scientific concepts and research design
- Ethical and participant safety considerations
- Medicines development and regulation
- Clinical trial operations
- Study and site management
- Data management and informatics
- Leadership and professionalism
- Communication and teamwork
Sonstein S., Seltzer J., Li R., Jones C., Silva H., Daemen E. (2014). Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clin. Res. 28 17–23.
Calvin-Naylor N. A., Thomas-Jones C., Wartak M. M., Blackwell K., Davis J. M., Divecha R., et al. (2017). Education and training of clinical and translational study investigators and research coordinators: a competency-based approach. J. Clin. Trans. Sci. 1 16–25. 10.1017/cts2016
Regulatory Science Core Thematic Areas
Competencies for regulatory science, which is a growing discipline in medical-related applications. Competencies for this complex field were identified and categorized into 11 Thematic Areas. These areas are based on a subset of the FDA’s priority areas and are accompanied by explanations of their development and broader recommendations to enrich education and training.
The 11 Regulatory Science Thematic Areas:
- Regulatory Science Research Questions and Priorities
- Regulatory Policies and Process
- Research Ethics
- Drug Discovery and Development
- Medical Device Innovation
- Clinical Trials
- Post-Marketing and Compliance
- Analytical Approaches and Tools
- Technology and Innovation