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Indices of clinical research coordinators’ competence

  • Carlton A. Hornung (a1) (a2), Phillip A. Ianni (a3), Carolynn T. Jones (a4), Elias M. Samuels (a3), Vicki L. Ellingrod (a3) (a5) and for the DIAMOND Investigators (a1) (a2) (a3) (a4) (a5)...

Abstract

Introduction:

There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual’s preparedness to function efficiently in the clinical research enterprise and tools to evaluate the quality and effectiveness of programs that are designed to educate and train clinical research professionals. Here we report the development and validation of a competency self-assessment entitled the Competency Index for Clinical Research Professionals, version II (CICRP-II).

Methods:

CICRP-II was developed using data collected from clinical research coordinators (CRCs) participating in the “Development, Implementation and Assessment of Novel Training In Domain-Based Competencies” (DIAMOND) project at four clinical and translational science award (CTSA) hubs and partnering institutions.

Results:

An exploratory factor analysis (EFA) identified a two-factor structure: the first factor measures self-reported competence to perform Routine clinical research functions (e.g., good clinical practice regulations (GCPs)), while the second factor measures competence to perform Advanced clinical functions (e.g., global regulatory affairs). We demonstrate the between groups validity by comparing CRCs working in different research settings.

Discussion:

The excellent psychometric properties of CICRP-II and its ability to distinguish between experienced CRCs at research-intensive CTSA hubs and CRCs working in less-intensive community-based sites coupled with the simplicity of alternative methods for scoring respondents make it a valuable tool for gauging an individual’s perceived preparedness to function in the role of CRC as well as an equally valuable tool to evaluate the value and effectiveness of clinical research education and training programs.

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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.

Corresponding author

Address for correspondence: C. A. Hornung, PhD, MPH, Department of Medicine, University of Louisville, 18613 John Connor Rd., Cornelius, NC 28031, USA. Email: CAHornung@Louisville.edu

References

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1. Hornung, CA, et al. Competency indices to assess the knowledge, skills and abilities of clinical research professionals. International Journal of Clinical Trials 2018; 5(1): 4653.
2. Institute of Medicine. Transforming Clinical Research in the United States. Washington, DC: National Academies Press, 2010.
3. Califf, R, et al. 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.
4. Jones, CT, et al. Defining competencies in clinical research: Issues in clinical research education. Research Practitioner 2012; 13(3): 99107.
5. Sonstein, S, et al. Global self-assessment of competencies, role relevance, and training needs among clinical research professionals. Clinical Researcher 2016; 30(6): 3845. DOI:10.14524/CR-16-0016
6. Sonstein, SA, et al. Moving from compliance to competency: A harmonized core competency framework for the clinical research professional. Clinical Researcher 2014; 28(3): 1723.
7. Joint Task Force for Clinical Trial Competency. Core competency framework, 2.0. 2017. Retrieved from http://clinicaltrialcompetency.org.
8. Shanley, T. Enhancing clinical research professionals’ training and qualifications. Retrieved from http://www.ctsa-gcp.org/. Accessed February 12, 2016.
9. Mullikin, E, Bakken, LL, Betz, NE. Assessing the research self-efficacy in physician scientists: The clinical research appraisal inventory. Journal of Clinical Assessment 2007; 88(9): 13401345.
10. Lipira, L, et al. Evaluation of clinical research training programs using the clinical research appraisal inventory. Clinical and Translational Science 2010; 3(5): 243248.
11. Robinson, G, et al. A shortened version of the Clinical Research Appraisal Inventory: CRAI-12. Academic Medicine 2013; 88(9): 13401345.
12. Eller, L, Lev, EL, Bakken, LL. Development and testing of the Clinical Research Appraisal Inventory-Short Form. Journal of Nursing Measurement 2014; 22(1): 106119.
13. Sullivan, GM. A primer on the validity of assessment instruments. Journal of Medical Graduate Education 2011; 3(2): 119120.
14. Kane, MT. An argument-based approach to validity. Psychological Bulletin 1992; 112(3): 527535.
15. DeVellis, RF. Scale Development: Theory and Applications. 2nd ed. Newbury Park, CA: Sage Publications, 2003.
16. Snyder, D, et al. Retooling institutional support infrastructure for clinical research. Contemporary Clinical Trials 2016; 48: 139145.
17. Causey, M. Professional pathways boost staff retention in clinical research settings. ACRP Blog; 2017. Retrieved from www.acrpnet.org/2017/04/24/professional-pathways-boost-staff-retention-clinical-research-settings/
18. Applied Clinical Trials. Clinical trials talent survey report; 2018. Retrieved from =http://www.appliedclinicaltrialsonline.com/node/351341/done?sid=15167
19. Bandura, A. A guide for constructing self efficacy scales, Chapter 14. In: Pajores, F, Urdan, T, eds. Self-Efficacy Beliefs of Adolescents. Greenwich, CT: Information Age Publishing; 2006. 307337.
20. Bjork, RA. Assessing our own competence: Heuristics and illusions. In: Gopher, D, Koriat, A eds. Attention and Performance XVII. Cognitive Regulation of Performance: Interaction of Theory and Application. Cambridge, MA: MIT Press; 1998. 435459.
21. Dunning, D, Heath, C, Suls, JM. Flawed self-assessment: Implications for health, education, and the workplace. Psychological Science in the Public Interest 2004; 5(3): 69106.

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