Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training.
Autor: | Sonstein SA; Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, 14 Story Street, 4th Floor, Cambridge, MA, 02138, USA., Samuels E; Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, MI, USA., Aldinger C; Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, 14 Story Street, 4th Floor, Cambridge, MA, 02138, USA., White SA; Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, 14 Story Street, 4th Floor, Cambridge, MA, 02138, USA., Bierer BE; Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, 14 Story Street, 4th Floor, Cambridge, MA, 02138, USA. bbierer@bwh.harvard.edu.; Harvard Medical School, Boston, MA, USA. bbierer@bwh.harvard.edu. |
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Jazyk: | angličtina |
Zdroj: | Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2022 Jul; Vol. 56 (4), pp. 607-615. Date of Electronic Publication: 2022 Mar 31. |
DOI: | 10.1007/s43441-022-00395-z |
Abstrakt: | 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. (© 2022. The Drug Information Association, Inc.) |
Databáze: | MEDLINE |
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