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Calvin-Naylor NA, Jones CT, Wartak MM, et al. Education and training of clinical and translational study investigators and research coordinators: A competency-based approach. J Clin Transl Sci. 2017;1(1):16-25doi: 10.1017/cts.2016.2.
Calvin-Naylor, N. A., Jones, C. T., Wartak, M. M., Blackwell, K., Davis, J. M., Divecha, R., Ellerbeck, E. F., Kieburtz, K., Koziel, M. J., Luzuriaga, K., Maddox, J., Needler, N. A., Murphy, S., Pemberton, K., Radovich, C., Rubinstein, E. P., Selker, H. P., Tenaerts, P., Unsworth, K., Wilson, K., Wright, J. E., Barohn, R., & Shanley, T. P. (2017). Education and training of clinical and translational study investigators and research coordinators: A competency-based approach. Journal of clinical and translational science, 1(1), 16-25. https://doi.org/10.1017/cts.2016.2
Calvin-Naylor, Nancy A, et al. "Education and training of clinical and translational study investigators and research coordinators: A competency-based approach." Journal of clinical and translational science vol. 1,1 (2017): 16-25. doi: https://doi.org/10.1017/cts.2016.2
Calvin-Naylor NA, Jones CT, Wartak MM, Blackwell K, Davis JM, Divecha R, Ellerbeck EF, Kieburtz K, Koziel MJ, Luzuriaga K, Maddox J, Needler NA, Murphy S, Pemberton K, Radovich C, Rubinstein EP, Selker HP, Tenaerts P, Unsworth K, Wilson K, Wright JE, Barohn R, Shanley TP. Education and training of clinical and translational study investigators and research coordinators: A competency-based approach. J Clin Transl Sci. 2017 Feb;1(1):16-25. doi: 10.1017/cts.2016.2. Epub 2017 Jan 13. PMID: 28480054; PMCID: PMC5408836.
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J Clin Transl Sci. 2017 Feb;1(1):16-25. doi: 10.1017/cts.2016.2. Epub 2017 Jan 13.

Education and training of clinical and translational study investigators and research coordinators: A competency-based approach.

Journal of clinical and translational science

Nancy A Calvin-Naylor, Carolynn Thomas Jones, Michelle M Wartak, Karen Blackwell, Jonathan M Davis, Ruthvick Divecha, Edward F Ellerbeck, Karl Kieburtz, Margaret J Koziel, Katherine Luzuriaga, Jennifer Maddox, Nancy A Needler, Susan Murphy, Kieran Pemberton, Catherine Radovich, Eric P Rubinstein, Harry P Selker, Pamela Tenaerts, Kelly Unsworth, Kay Wilson, Jonelle E Wright, Richard Barohn, Thomas P Shanley

Affiliations

  1. Institute for Research on Innovation and Science (IRIS), University of Michigan, Ann Arbor, MI, USA.
  2. College of Nursing, Ohio State University, Columbus, OH, USA.
  3. Broad Institute of MIT, Tufts University, Boston, MA, USA.
  4. Human Research Protection Program, University of Kansas, Kansas City, KS, USA.
  5. Frontiers: The Heartland Institute for Clinical and Translational Science, University of Kansas, Fairway, KS, USA.
  6. Medical Affairs, University of Michigan, Ann Arbor, MI, USA.
  7. Department of Preventive Medicine and Public Health, University of Kansas, Kansas City, KS, USA.
  8. Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA.
  9. UMass Center for Clinical and Translational Science, University of Massachusetts, Lowell, MA, USA.
  10. Michigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USA.
  11. Clinical and Translational Science Institute, Tufts University, Boston, MA, USA.
  12. Clinical Trials Transformation Initiative, Durham, NC, USA.
  13. Human Subject Protection Program, University of Rochester, Rochester, NY, USA.
  14. Clinical and Translational Science Institute, University of Miami, Miami, FL, USA.
  15. Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

PMID: 28480054 PMCID: PMC5408836 DOI: 10.1017/cts.2016.2

Abstract

INTRODUCTION: Training for the clinical research workforce does not sufficiently prepare workers for today's scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals' Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.

METHODS: Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.

RESULTS: Forty-eight competency statements in 8 domains were developed.

CONCLUSIONS: Training is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

Keywords: CTSA; Clinical research training; Competency assessments; Competency standards

References

  1. Oncol Nurs Forum. 2004 May 12;31(3):E64-8 - PubMed
  2. Oncol Nurs Forum. 2011 Mar;38(2):E72-80 - PubMed
  3. Clin Transl Sci. 2011 Dec;4(6):421-7 - PubMed
  4. Clin Pharmacol Ther. 2013 Aug;94(2):230-42 - PubMed

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