Competency indices to assess the knowledge, skills and abilities of clinical research professionals
Background: Clinical research in the 21st century will require a well-trained workforce to ensure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel and others.
Methods: We used data collected by the joint task force on the harmonization of core competencies from a survey of research professionals working in the US and Canada to create competency Indices for clinical research professionals. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies.
Results: Factor analyzes identified 20 core competencies that defined a competency index for clinical research professionals—general (CICRP-General, i.e., GCPs) and four sub-indices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts.
Conclusions: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors and other clinical research team members.
World Medical Association. Declaration of Helsinki- Ethical principles for medical research involving human subjects. 2013; Available at: http://www.wma.net/en/30publications/10policies/b3/ Accessed on 1 October 2016.
Institute of Medicine. Transforming clinical research in the United States. Washington, D.C.: National Academies Press; 2010.
Califf R, Filerman GL, Murray RK, Rosenblatt M. Appendix D: Discussion Paper- The clinical trials enterprise in the United States: A call for disruptive innovation. In: Institute of Medicine, ed. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020. Washington, DC: National Academies Press; 2012.
Collins F, Varmus, H. A new initiative on precision medicine. N Engl J Med. 2015;372(9):793-5.
Ford INJ. Pragmatic Trials. N Engl J Med. 2016;375:454-63.
Anderson ML, Griffin J, Goldkind SF, Zeitler EP, Wing L, Al-Khatib SM, et al. The Food and Drug Administrationo and pragmatic clinical trials of marketed medical products. Clin Trials. 2015;12:511-9.
Fiore L, Lavori PW. Integrating randomized comparative effectiveness research with patient care. N Engl J Med. 2016;374:2152-8.
Jones CT, Parmentier J, Sonstein S, Silva H, Lubejko, Pidd, et al. Defining competencies in clinical research: Issues in clinical research education. Res Practitioner. 2012;13(3):99-107.
Sonstein SA, Seltzer J, Li R, Jones CT, Silva H, Daemen E. Moving from compliance to competency: A harmonized core competency framework for the clinical research professional. Clin Res. 2014;28(3):17-23.
Sonstein S, Silva, H, Jones, CT, Calvin-Naylor, N, Halloran, L, Yrivarren, JL. Global self-assessment of competencies, role relevance, and training needs among clinical research professionals. Clin Res. 2016;30(6):38-45.
Shanley T. Enhancing Clinical Research Professionals' Training and Qualifications. http://www.ctsa-gcp.org/. Accessed on 12 February 2016.
Speicher L, Fromwell G, Avery S, Brassil D, Stevens E, Toms M. The critical need for academic health centers to assess the training, support and career development of clinical research coordinators: Recommendations from the clinical and translational science award research coordinator task force. Clin Translational Sci. 2012;5(6):470-5.
Mullikin E, Bakken, LL, Betz, NE. Assessing the research self-efficacy in physician scientists: The clinical research appraisal inventory. J Clin Assessment. 2007;88(9):1340-5.
Libira L, Jeffe DB, Krauss M, Garbutt J, Piccirillo J, Evanoff B, et al. Evaluation of clinical research training programs using the clinical research appraisal inventory. Clin Translational Sci. 2010;3(5):243-8.
Robinson G, Switzer GE, Cohen ED, Primack BA, Kapoor WN, Seltzer DL, et al. A shortened version of the Clinical Research Appraisal Inventory: CRAI-12. Acad Med. 2013;88(9):1340-5.
Eller L, Lev EL, Bakken LL. Development and testing of the Clinical Research Apraisal Inventory-Short Form. J Nursing Measurement. 2014;22(1):106-19.
Bier S, Prayson RA, Dannefer EF. Association of research self-efficacy with medical student career interests, specialization and scholarship: A case study. Adv Health Sci Edu. 2015;20(2):339-54.
Bandura A. Self-efficacy: Toward a unifying theory of behavior change. Psychol Rev. 1977;84(2):191-215.
Fisher J. Co-ordinating ‘ethical’ clinical trials: the role of research coordinators in the contract research industry. Sociol Health Illness. 2006;28(6):678-94.
Brower R, Moen R, Hannah D, Mullen C, Ainsworth T, McKellar T, et al. Competency-based job classifications for research professional. Translational Science, Washington, DC, 2016.
Snyder D, Brouwer RN, Ennis CL, Spangler LL, Ainsworth TL, Budinger S, et al. Retooling institutional support infrastructure for clinical research. Contemp Clin Trials. 2016;48:139-45.