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.
Brouwer RN, Deeter C, Hannah D, et al. Using competencies to transform clinical research job classifications. J Res Admin. 2017;48(2):11–25.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
ACRP-CP Certification. https://acrpnet.org/certifications/acrp-cp-certification/. Accessed on 1 Nov 2021.
SoCRA Candidate Eligibility. https://www.socra.org/certification/ccrp-certification-exam/candidate-eligibility/. Accessed on 1 Nov 2021.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
DeVellis RF. Scale development. In: Theory and applications. 2nd ed. Newbury Park: Sage; 2003.
Kane MT. An argument-based approach to validity. Psychol Bull. 1992;112(3):527–35.
Sullivan GM. A primer on the validity of assessment instruments. J Med Grad Educ. 2011;3(2):119–20.
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.
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.
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.
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.
Vulcano D. CPI certification as predictor of clinical investigators’ regulatory compliance. Drug Inf J. 2012;46(1):84–7.
Silva H, Stonier P, Buhler F, et al. Core competencies for pharmaceutical physicians and drug development scientists. Front Pharmacol. 2013;4(105):1–7.
Koren M, Koski G, Reed DP, et al. APPI physician investigator competencies statement. Monitor. 2011;25(4):79–82.
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.
Regulatory Affairs Professionals Society. Regulatory competency framework. (2016). https://www.raps.org/careers/regulatory-competency-framework. Accessed on 1 Nov 2021.
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.
CAAHEP—Clinical Research. (n.d.). https://www.caahep.org/CAAPCR.aspx. Accessed on 25 May 2021.
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.
Moskowitz J, Thompson JN. Enhancing the clinical research pipeline: training approaches for a new century. Acad Med. 2001;76(4):307–15.