Skip to main content Accessibility help
×
Home

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

  • Nancy A. Calvin-Naylor (a1), Carolynn Thomas Jones (a2), Michelle M. Wartak (a3), Karen Blackwell (a4), Jonathan M. Davis (a5), Ruthvick Divecha (a6), Edward F. Ellerbeck (a7), Karl Kieburtz (a8), Margaret J. Koziel (a9), Katherine Luzuriaga (a9), Jennifer Maddox (a5), Nancy A. Needler (a8), Susan Murphy (a10), Kieran Pemberton (a5), Catherine Radovich (a10), Eric P. Rubinstein (a8), Harry P. Selker (a11), Pamela Tenaerts (a12), Kelly Unsworth (a13), Kay Wilson (a10), Jonelle E. Wright (a14), Richard Barohn (a5) and Thomas P. Shanley (a15)...

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.

  • View HTML
    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

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

      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

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

      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

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

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 Pressmust be obtained for commercial re-use or in order to create a derivative work.

Corresponding author

*Address for correspondence: N. Calvin-Naylor, Ph.D., University of Michigan, 426 Thompson Street, Room 3304, Ann Arbor, MI 48106, USA. (Email: nbirk@umich.edu)

References

Hide All
1. Institute of Medicine. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press, 2012.
2. Khin, NA, et al. Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective. Clinical Pharmacology and Therapeutics 2013; 94: 230242.
3. Seltzer, J. Increasing the efficiency of GCP training: recommendations from the Clinical Trials Transformation Initiative. Presented at 2nd National Working Group Meeting for Enhancing Clinical Research Professional Training and Qualifications, February 10, 2015, Dallas, TX.
4. Hendricson, WD. Appropriate Assessments for Competency-Based Education. Washington, D.C.: American Dental Education Association, 2008.
5. Sonstein, SA, et al. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clinical Researcher 2014; 3: 1723.
6. Boahin, PHW. Perceived effects of competency-based training on the acquisition of professional skills. International Journal of Educational Development 2014; 36: 8189.
7. Society, ON. Oncology clinical trials nurse competencies 2010. [Internet]. 2010 [cited May 3, 2016]. (https://www.ons.org/sites/default/files/ctncompetencies.pdf)
8. Royal College of Nursing. Research nurse competency framework [Internet]. Royal College of Nursing, London, UK, 2011 [cited May 13, 2016]. (http://cambridge.crf.nihr.ac.uk/wp-content/uploads/2015/04/Research_Nurse_Competency_Framework_-_Version_2_-_Full_-_Oct_20111.pdf)
9. CRN 2010 Domain of Practice Committee. Building the foundation for clinical research nursing: domain of practice for the specialty of clinical research nursing [Internet]. National Institutes of Health Clinical Center, Nursing and Patient Care Services, Bethesda, MD, 2009 [cited May 3, 2016]. (http://www.cc.nih.gov/nursing/crn/DOP_document.pdf)
10. Ehrenberger, HE, Lilington, L. Development of a measure to delineate the clinical trials nursing role. Oncology Nursing Forum 2004; 31: E64E68.
11. Castro, K, et al. Validating the clinical research nursing domain of practice. Oncology Nursing Forum 2011; 38: E72E80.
12. Bevans, M, et al. Defining clinical research nursing practice: results of a role delineation study. Clinical and Translational Science 2011; 6: 421427.
13. Jones, CT, Wilson, LL. Role perceptions of nurse clinical research coordinators. Nursing: Research and Reviews 2013; 3: 133139.
14. Jones, CT, Wilson, LL. Clinical research nurses’ perceptions of research activities performed by unsupervised non-nurse clinical research coordinators. The Monitor 2014; 28: 1219.
15. Clinical and Translational Science Awards. Core competencies for clinical and translational research [Internet]. 2011 [cited May 3, 2016]. (https://ctsacentral.org/consortium/best-practices/335-2)
16. Silva, H, et al. Alignment of competencies to address inefficiencies in medicines development and clinical research: need for inter-professional education. Pharmaceutical Medicine 2015; 29: 131140.
17. Jones, CT, et al. Defining competencies in clinical research: issues in clinical research education. Research Practitioner 2012; 12: 99107.
18. Bloom, BS, et al. Taxonomy of Educational Objectives: The Classification of Educational Goals. Volume I: Cognitive Domain. New York: May; 1956.
19. Sonstein, S. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Presentation and live webinar at the University of Florida, November 17, 2015, Gainesville, FL.

Keywords

Metrics

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed