Competency indices to assess the knowledge, skills and abilities of clinical research professionals

Authors

  • Carlton A. Hornung Consortium of Academic Programs in Clinical Research, School of Medicine, University of Louisville
  • Carolynn Thomas Jones Consortium of Academic Programs in Clinical Research, University of Louisville School of Nursing, Ohio State University, Ohio http://orcid.org/0000-0002-0669-7860
  • Nancy A. Calvin-Naylor Institute for Social Research, University of Michigan, Michigan
  • Jared Kerr School of Nursing, University of North Carolina at Wilmington, North Carolina
  • Stephen A. Sonstein Consortium of Academic Programs in Clinical Research, University of Louisville School of Health Sciences, Eastern Michigan University, Michigan
  • Terri Hinkley Academy of Medical-Surgical Nurses
  • Vicki L. Ellingrod College of Pharmacy, University of Michigan, Michigan

DOI:

https://doi.org/10.18203/2349-3259.ijct20180130

Keywords:

Core competence, Clinical research professional, Self-efficacy, Factor analysis, Competency index, Workforce development

Abstract

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.

Author Biographies

Carlton A. Hornung, Consortium of Academic Programs in Clinical Research, School of Medicine, University of Louisville

Lead Author

Immediate Past-President, Consortium of Academic Programs in Clinical Research; Professor, School of Medicine, University of Louisville

Carolynn Thomas Jones, Consortium of Academic Programs in Clinical Research, University of Louisville School of Nursing, Ohio State University, Ohio

Carolyn Thomas Jones, DNP, MSPH, RN is Associate Professor with The Ohio State University College of Nursing and the Lead Faculty for the Master’s in Applied Clinical and Pre-Clinical Research (MACPR) Clinical Research Management Specialty and Core Courses.  Dr. Jones has nearly 30 years experience as a clinical research professional.  She is a member of the Joint Task Force for Harmonized Clinical Research Core Competencies and has a research interest in nursing roles in the clinical research enterprise.  

Nancy A. Calvin-Naylor, Institute for Social Research, University of Michigan, Michigan

Director, Institute for Social Research, University of Michigan

Jared Kerr, School of Nursing, University of North Carolina at Wilmington, North Carolina

Assistant Professor,Clinical Research Program, College of Health and Human Services, University of North Carolina, Wilmington

Stephen A. Sonstein, Consortium of Academic Programs in Clinical Research, University of Louisville School of Health Sciences, Eastern Michigan University, Michigan

Professor and Director, Masters of Research Administration Program, Eastern Michigan University

Terri Hinkley, Academy of Medical-Surgical Nurses

Chief Executive Officer, Academy of Medical-Surgical Nurses

Vicki L. Ellingrod, College of Pharmacy, University of Michigan, Michigan

Professor, School of Medicine, University of Michigan

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Published

2018-01-23

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Section

Original Research Articles