Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Research
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Sonstein SA, Seltzer J, Li R, et al. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clin Res. 2014;28(3):17–235.

    Google Scholar 

  2. Brouwer RN, Deeter C, Hannah D, et al. Using competencies to transform clinical research job classifications. J Res Admin. 2017;48(2):11–25.

    Google Scholar 

  3. Behar-Horenstein LS, Potter JE, Prikhidko A, et al. Training impact on novice and experienced research coordinators. Qual Rep. 2017. https://doi.org/10.46743/2160-3715/2017.3192.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Calvin-Naylor NA, Jones CT, Wartak M, 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):16–25. https://doi.org/10.1017/cts.2016.2.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Stroo M, Asfaw K, Deeter C, et al. Impact of implementing a competency-based job framework for clinical research professionals on employee turnover. J Clin Transl Sci. 2020; 4(4):331–335. https://doi.org/10.1017/cts.2020.22.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Saunders J, Pimenta K, Zuspan S, et al. Inclusion of the Joint Task Force competency domains in onboarding for CRC’s. Clin Res. 2017. https://doi.org/10.14524/CR-17-0007.

    Article  Google Scholar 

  7. Zozus M, Lazarov A, Smith L. Analysis of professional competencies for the clinical research data management profession: implications for training and professional certification. J Inform Health Biomed. 2017;24(4):737–45.

    Google Scholar 

  8. Shimoda K, Watanabe H. Joint Task Force for Clinical Trial Competency (Japanese translation) Joint Task Force for Clinical Trial Competency 日本語訳. Rinsho/Yakuri Jpn J Clin Pharmacol Ther. 2020. https://doi.org/10.3999/jscpt.51.131.

    Article  Google Scholar 

  9. Lee JY, Lensing SV, Botello-Harbaum MT, Medina R, Zosus M. Assesssing clinical investigator’s perceptions of relevance and competency of clinical trial skills: an international AIDS Malignancy Consortium (AMC) study. J Clin Transl Sci. 2020;5:e28. https://doi.org/10.1017/cts.2020.520.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Sonstein SA, Namenek Brouwer RJ, Gluck W, et al. Leveling the Joint Task Force Core competencies for clinical research professionals. Ther Innov Regul Sci. 2018. https://doi.org/10.1177/2168479018799291.

    Article  Google Scholar 

  11. Sonstein S, Silva H, Thomas-Jones C, et al. Global self-assessment of competencies, role relevance, and training needs among clinical research professionals. Clin Res. 2016;30(6):42–9.

    Google Scholar 

  12. Hinkley, T. Workforce innovation: let’s focus on competency, not tenure. Clinical Researcher. 2017. https://acrpnet.org/2017/02/01/workforce-innovation-lets-focus-on-competency-not-tenure/. Accessed on 23 May 2021.

  13. ACRP-CP Certification. https://acrpnet.org/certifications/acrp-cp-certification/. Accessed on 1 Nov 2021.

  14. SoCRA Candidate Eligibility. https://www.socra.org/certification/ccrp-certification-exam/candidate-eligibility/. Accessed on 1 Nov 2021.

  15. Ianni PA, Samuels EM, Eakin BL, et al. Assessments of research competencies for clinical investigators: a systematic review. Eval Health Prof. 2019. https://doi.org/10.1177/0163278719896392.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Awaisu A, Kheir N, Alrowashdeh HA, et al. Impact of a pharmacy practice research capacity-building programme on improving the research abilities of pharmacists at two specialised tertiary care hospitals in Qatar: a preliminary study. J Pharm Health Serv Res. 2015;6(3):155–64. https://doi.org/10.1111/jphs.12101.

    Article  Google Scholar 

  17. Ellis JJ, McCreadie SR, McGregory M, et al. Effect of pharmacy practice residency training on residents’ knowledge of and interest in clinical research. Am J Health Syst Pharm. 2007;64(19):2055–63. https://doi.org/10.2146/ajhp070063.

    Article  PubMed  Google Scholar 

  18. Jeffe DB, Rice TK, Boyington JEA, et al. Development and evaluation of two abbreviated questionnaires for mentoring and research self-efficacy. Ethn Dis. 2017;27(2):179–88. https://doi.org/10.18865/ed.27.2.179.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Lowe B, Hartmann M, Wild B, et al. Effectiveness of a 1-year resident training program in clinical research: a controlled before-and-after study. J Gen Intern Med. 2008;23(2):122–8. https://doi.org/10.1007/s11606-007-0397-8.

    Article  PubMed  Google Scholar 

  20. Patel MS, Tomich D, Kent TS, et al. A program for promoting clinical scholarship in general surgery. J Surg Educ. 2018;75(4):854–60. https://doi.org/10.1016/j.jsurg.2018.01.001.

    Article  PubMed  Google Scholar 

  21. Robinson GFWB, Moore CG, McTigue KM, et al. Assessing competencies in a master of science in clinical research program: the comprehensive competency review. Clin Transl Sci. 2015;8(6):770–5. https://doi.org/10.1111/cts.12322.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Robinson GFWB, Switzer GE, Cohen ED, et al. A shortened version of the clinical research appraisal inventory: CRAI-12. Acad Med. 2013;88(9):1340–5. https://doi.org/10.1097/ACM.0b013e31829e75e5.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Lipira L, Jeffe DB, Krauss M, et al. Evaluation of clinical research training programs using the clinical research appraisal inventory. Clin Transl Sci. 2010;3(5):243–8. https://doi.org/10.1111/j.1752-8062.2010.00229.x.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Mullikin EA, Bakken LL, Betz NE. Assessing research self-efficacy in physician-scientists: the clinical research appraisal inventory. J Career Assess. 2007;15(3):367–87. https://doi.org/10.1177/1069072707301232.

    Article  Google Scholar 

  25. Streetman DS, McCreadie SR, McGregory M, et al. Evaluation of clinical research knowledge and interest among pharmacy residents: survey design and validation. Am J Health Syst Pharm. 2006;63(23):2372–7. https://doi.org/10.2146/ajhp060099.

    Article  PubMed  Google Scholar 

  26. Cuser DA, Brown SK, Ingram JR, et al. Learning outcomes from a biomedical research course for second year osteopathic medical students. Osteopath Med Prim Care. 2010;4:4. https://doi.org/10.1186/1750-4732-4-4.

    Article  Google Scholar 

  27. Cruser DA, Dubin B, Brown SK, et al. Biomedical research competencies for osteopathic medical students. Osteopath Med Prim Care. 2009;3:10. https://doi.org/10.1186/1750-4732-3-10.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Ameredes BT, Hellmich MR, Cestone CM, et al. The Multidisciplinary Translational Team (MTT) model for training and development of translational research investigators. Clin Transl Sci. 2015;8(5):533–41. https://doi.org/10.1111/cts.12281.

    Article  PubMed  PubMed Central  Google Scholar 

  29. DeVellis RF. Scale development. In: Theory and applications. 2nd ed. Newbury Park: Sage; 2003.

    Google Scholar 

  30. Kane MT. An argument-based approach to validity. Psychol Bull. 1992;112(3):527–35.

    Article  Google Scholar 

  31. Sullivan GM. A primer on the validity of assessment instruments. J Med Grad Educ. 2011;3(2):119–20.

    Article  Google Scholar 

  32. Dunning D, Heath C, Suls JM. Flawed self-assessment: implications for health, education, and the workplace. Psychol Sci Public Interes. 2004;5(3):69–106. https://doi.org/10.1111/j.1529-1006.2004.00018.x.

    Article  Google Scholar 

  33. Dunning D. The Dunning–Kruger effect: on being ignorant of one’s own ignorance. In: Advances in experimental social psychology, vol. 44. Cambridge: Academic Press; 2011. p. 247–96.

    Google Scholar 

  34. Centerwatch. (n.d.). Report: global clinical trial service market will reach $64B by 2020. http://www.centerwatch.com/news-online/2017/02/08/report-global-clinical-trial-service-market-will-reach-64b-2020/. Accessed on 19 May 2021.

  35. Sonstein SA, Jones CT. Joint task force for clinical trial competency and clinical research professional workforce development. Front Pharmacol. 2018. https://doi.org/10.3389/fphar.2018.01148.

    Article  PubMed  PubMed Central  Google Scholar 

  36. Vulcano D. CPI certification as predictor of clinical investigators’ regulatory compliance. Drug Inf J. 2012;46(1):84–7.

    Article  Google Scholar 

  37. Silva H, Stonier P, Buhler F, et al. Core competencies for pharmaceutical physicians and drug development scientists. Front Pharmacol. 2013;4(105):1–7.

    CAS  Google Scholar 

  38. Koren M, Koski G, Reed DP, et al. APPI physician investigator competencies statement. Monitor. 2011;25(4):79–82.

    Google Scholar 

  39. Association of Clinical Research Professionals. ACRP core competency guidelines for clinical research coordinators. 2017. https://acrpnet.org/acrp-partners-in-workforce-advancement/core-competency-guidelines-clinical-research-coordinators-crcs/. Accessed on 1 Nov 2021.

  40. Regulatory Affairs Professionals Society. Regulatory competency framework. (2016). https://www.raps.org/careers/regulatory-competency-framework. Accessed on 1 Nov 2021.

  41. Ji P, Wang H, Zhang C, et al. A survey on clinical research training status and needs in public hospitals from Shenzhen. J Educ Train Stud. 2017;12:56–49.

    Google Scholar 

  42. CAAHEP—Clinical Research. (n.d.). https://www.caahep.org/CAAPCR.aspx. Accessed on 25 May 2021.

  43. Shanley TP, Calvin-Naylor NA, Divecha R, et al. Enhancing clinical research professionals’ training and qualification (ECRPTQ): recommendations for good clinical practice (GCP) training for investigators and study coordinators. J Clin Transl Sci. 2017. https://doi.org/10.1017/cts.2016.1.

    Article  PubMed  PubMed Central  Google Scholar 

  44. Moskowitz J, Thompson JN. Enhancing the clinical research pipeline: training approaches for a new century. Acad Med. 2001;76(4):307–15.

    Article  CAS  Google Scholar 

Download references

Funding

There was no external funding received related to this study.

Author information

Authors and Affiliations

  1. Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, 14 Story Street, 4th Floor, Cambridge, MA, 02138, USA

    Stephen A. Sonstein, Carmen Aldinger, Sarah A. White & Barbara E. Bierer MD

  2. Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, MI, USA

    Elias Samuels

  3. Harvard Medical School, Boston, MA, USA

    Barbara E. Bierer MD

Authors
  1. Stephen A. Sonstein
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Elias Samuels
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Carmen Aldinger
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Sarah A. White
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Barbara E. Bierer MD
    View author publications

    You can also search for this author in PubMed Google Scholar

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.

Ethics declarations

Conflict of interest

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

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 444 KB)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

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

Keywords

Search

Navigation