In order to fill the gap in junior investigator training, Tufts University Clinical and Translational Science Institute (CTSI) has utilized the JTF Core Competency Framework to develop an eight-module, certificate program to teach aspiring clinician-investigators about good clinical practice, clinical research processes, and federal and local regulatory requirements.

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Recently, the JTF published in Therapeutic Innovation & Regulatory Science the results of a global survey of clinical research professionals who were asked to self-assess their level of competency for each of the 8 domains of the JTF Framework.  The results were very similar to those of a similar 2016 published JTF survey showing that irrespective of role, years of experience or educational level, lower levels of competency were expressed in the domains of Scientific Concepts and Research Design and Investigational Product Development and Regulation.  The recent survey showed an additional lower level of competency for the Data Management and Informatics domain.  Respondents with professional certification in clinical research self-assessed their competency at higher levels in all domains than those without professional certification.

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Recently published in Therapeutic Innovation & Regulatory Science, the Joint Task Force for Clinical Trial Competency (JTF) defined and documented core competencies related to clinical project management and project management skills. Two new specific competencies with related examples were incorporated in Version 3.1 of the JTF Framework and the wording of several existing competencies was modified.

Communication and Teamwork in JTF Framework

This article focuses on Domain 8 of the JTF Framework – Communication and Teamwork.   The authors have emphasized the importance of communication skills between Clinical Research Professionals and the perception of competence.

Duke University integrating the JTF Framework into is clinical research enterprise

Duke University School of Medicine and Nursing has been an innovator in integrating the JTF Framework into its clinical research enterprise.  This article discusses the impact of classifying clinical research roles according to the JTF Competency Framework on workforce turnover in an academic medical center.  Significant reduction in personnel turnover was noted following the reclassification and reduction in number of defined roles.

The AIDS Malignancy Consortium (AMC) conducted a survey of clinical investigators in Latin America and Sub-Saharan Africa to determine self-assessed competency, utilizing the JTF Clinical Research Core Competency Framework, to inform training and professional development needs.  The results were similar to prior findings by the JTF (Clinical Researcher, 2016:3;42-49) showing lower levels of competency in the domains of Scientific Concepts and Research Design, Medicines Development and Regulation and Data Management and Informatics.  The AMC is using the JTF Framework to develop a training curriculum tailored to the needs of their clinical staff.

Virginia Commonwealth University (VCU), C. Kenneth and Dianne Wright Center for Clinical and Translational Research Translational Workforce Development Program relies on the JTF Framework for overall workforce development activities, provides the JTF Framework as an ongoing education and training resource to the workforce, aligns Clinical Research Skills Series workshop learning objectives to the core competencies, and designed the Post-baccalaureate Certificate in Clinical Research core and elective courses requirements based on the framework competencies.  cctr.vcu.edu

In this peer-reviewed article, authors Joseph M. Bocchino, EdD, Joan Butler, EdD, MS, and Beth Harper, MBA, BS (OT), review the literature addressing the current state of education within the clinical research profession to ascertain directions in which the profession and its supporting educators may be moving in order to further develop clinical research workforce capacity.  The importance of competency-based education and the JTF Core-Competency Framework are highlighted.

Duke University’s Office of Clinical Research has been on the forefront of utilizing the JTF Core competency Framework to define its role descriptions as well as to clearly specify how a clinical research professional can move upwards on their career ladders.  Their recent publication through the Society of Research Administrators International (SRAI), Volume LI, Number 2 explains these processes in detail.  The authors conclude that the utilization of the JTF Framework in this manner has benefited the institution by increasing CRP retention rates and allowed Duke to better understand current competency levels of its workforce.  Duke University’s Office of Clinical Research and their utilization of the JTF Core Competency Framework has been a model for the academic community and their efforts have been utilized by several of the Clinical and Translational Science Award institutions.

A paper appearing in the Journal of Clinical and Translational Research reported on a study by the International AIDS Malignancy Consortium which assessed the competency level and role relevance of the JTF Core Competencies in Clinical Investigators from Sub-Saharan Africa and Latin America.  The results indicated that the highest relevance to role was in the Scientific Concepts and Research Design and the Ethical and Participant Safety domains and the lowest in the Data Management and Informatics domain.  A high level of self-assessed competency was seen in the Ethical and Participant Safety domain, but lower levels of self-assessed competency were seen in the Data Management and Informatics and the Scientific Concepts and Research Design domains.   An additional domain, Community Engagement, was added to the framework by the investigators due to the perception of increased relevance in the assessed geographic regions, though interestingly, this domain showed a high level of competence, but a low level of role relevance.  The AMC is working to incorporate professional development offerings to investigators based upon the results of this assessment.