Competency indices to assess the knowledge, skills and abilities of clinical research professionals

Abstract

<p class="abstract"><strong>Background:</strong> Clinical research in the 21<sup>st</sup> century will require a well-trained workforce to ensure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel and others.</p><p class="abstract"><strong>Methods:</strong> We used data collected by the joint task force on the harmonization of core competencies from a survey of research professionals working in the US and Canada to create competency Indices for clinical research professionals. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies.</p><p class="abstract"><strong>Results:</strong> Factor analyzes identified 20 core competencies that defined a competency index for clinical research professionals—general (CICRP-General, i.e., GCPs) and four sub-indices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. </p><p><strong>Conclusions:</strong> These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors and other clinical research team members.</p>

The DIAMOND portal: An innovative platform for sharing translational research workforce training and assessment resources

“…Nearly two-thirds (26) of these assessments included measures of participant experiencesuch as engagement and satisfaction-and just over a one-third (15) include measures of specific learning outcomes. The DIAMOND team also participated in creating and testing a selfassessment aimed at measuring self-perceived self-efficacy in the competency domains called the Competency Index for Clinical Research Professionals [8,9]. This work is also available as an assessment in the DIAMOND portal.…”

Indices of clinical research coordinators’ competence

“…The timely and successful translation of pharmaceuticals and medical devices into clinical applications to improve human health requires a well-prepared and competent workforce of clinical research professionals that includes principal investigators, research coordinators, monitors, administrators, regulatory affairs experts, informaticians, data managers, statisticians, etc. Appropriate training and mastery of the competencies characterizing each role in the research process is essential for the efficient conduct of clinical and translational research (1,2,3) . Accordingly, there is a critical need for tools to assess an individual’s preparedness to execute her/his role in the research process; tools to assess an individual’s need for continuing education and training; and, tools to evaluate the quality of education and training programs that prepare individuals to work in the clinical research enterprise.…”

“…around the world to assess their self-perceived competence to perform the functions defined by the 51 core competencies. Details of the methods and results have been published elsewhere (1) . Briefly, exploratory factor analysis of data obtained from clinical research professionals employed in the U.S. or Canada identified 20 core competencies that formed 5 factors defining self-perceived competence to perform “General” research functions (e.g., GCPs) and four sub-scales reflecting specialized research functions: “Ethics and Patient Safety”; “Medicines Development”; “Data Management” and “Scientific Concepts”.…”

“…The five measures were highly correlated and had high face validity with reasonable psychometric properties. Most importantly, scores on the General Index, the Ethics and Patient Safety scale and the Medicine Development scale differed significantly (p < .05) among those who reported their role to be research coordinators, administrators, regulatory affairs specialists or data managers (1) .…”

Assessing an assessment: The review and redesign of a competency-based mid-degree evaluation

“…There is a substantial and growing literature on competency-based medical education [1,2], examining topics such as its theoretical grounding [3], its application to specialties such as internal medicine and gastronenterology [4,5], and the competencies required of research coordinators and other clinical research team members [6]. However, with a few notable exceptions [7][8][9] this literature has focused exclusively on clinical education and not on clinical research education, or preparation for academic medicine.…”