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Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

Abstract

The Joint Task Force for Clinical Trial Competency (JTF) conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework version 3.1. The results were analyzed based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. Respondents with professional certification self-assessed their competencies in all domains at higher levels than those without professional certification. The survey demonstrated that irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics. These results validate and extend the recommendations of a similar 2016 JTF and other surveys. We further recommend that clinical and translational research organizations and clinical sites assess training needs locally, using both subjective and objective measures of skill and knowledge.

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Funding

There was no external funding received related to this study.

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Authors

Contributions

SS: participation in study concept, questionnaire development, analysis of results, and manuscript development. ES: participation in analysis of results and manuscript development. CA: participation in questionnaire development, IRB submission, analysis of results, and manuscript development. SW: participation in questionnaire development, analysis of results, and manuscript development. BB: participation in study concept, questionnaire development, IRB submission, analysis of results, and manuscript development.

Corresponding author

Correspondence to Barbara E. Bierer MD.

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None of the authors declare any potential conflict of interest relevant to this work.

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Sonstein, S.A., Samuels, E., Aldinger, C. et al. Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training. Ther Innov Regul Sci 56, 607–615 (2022). https://doi.org/10.1007/s43441-022-00395-z

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  • DOI: https://doi.org/10.1007/s43441-022-00395-z

Keywords

  • Core competency
  • Clinical research
  • Joint Task Force for Clinical Trial Competency (JTF)
  • Workforce development