Academic journal article The Qualitative Report

Training Impact on Novice and Experienced Research Coordinators

Academic journal article The Qualitative Report

Training Impact on Novice and Experienced Research Coordinators

Article excerpt

Introduction

Identifying and implementing competency-based training and professional development programs are critical to the future of the clinical research enterprise. According to the International Conference on Harmonization Good Clinical Practice (ICH) individuals who conduct trials should be qualified by education, training, and experience (U. S. Department of Health and Human Services Food and Drug Administration, 1996). The training and education of research staff is integral to the success of the team and the studies they work on. However, standardization of training across all research staff, and within specific roles of the team, is limited (Duane, Granda, Munz, & Cannon, 2007). Developing a skilled professional workforce coincides with the World Health Organization's initiative on transforming health professionals' development (World Medical Association, 2013).

The current model of non-standardized training, given via online modules, may not adequately meet ICH guidelines or ensure professional competence. Competency development by definition refers to an observed ability that develops from an integration of knowledge, skills, values, and attitudes (Dreyfus, 2004; Frank et al., 2010). In Medicine, professionalism is often equated with competency. Epstein and Hundert (2002) suggested "professional competence is the habitual and judicious use of communication, knowledge, technical skills, clinical reasoning, emotions, values, and reflection in daily practice for the benefit of the individual and community being served" (p. 226). In the clinical research enterprise, each team member must acquire the necessary knowledge, training and experience so that they can successfully perform the responsibilities for conducting clinical research. However, the issue of ensuring competency is yet another matter.

A standardized training model based on common core competencies is instrumental to a professional workforce's ability to meet the demands of an evolving clinical research landscape. The Joint Task Force for Clinical Trial Competency (JTF) described eight domains and related cognitive competencies (Sonstein, Seltzer, Li, Silva, Jones, & Daemen, 2014). Subsequently, these competencies have been vetted by CTSA investigators on the Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ) NCATS supplement study (Calvin-Naylor et al., 2017). Movement towards competency-based educational standards coincided with recommendations from a Clinical and Translational Science Award (CTSA) Research Coordinator Taskforce. They called for expanding the scope of clinical research coordinators roles. Moreover, the task force recommended that enhanced educational opportunities were crucial to the support of professional development (Speicher et al., 2012). Evidence shows there are insufficient numbers of adequately trained and educated professionals in the workforce to address the overall evolving demands in the clinical research enterprise (Dickler, Korn, & Gabbe, 2006; Drain, Robine, Holmes, & Bassett, 2014; Silva et al., 2013). Educational evaluation research belays the critical need.

The training course reported in this study consisted of a prerequisite on-line course, the CITI Program's Clinical Research Coordinator (CRC) online course to provide research staff with basic knowledge. Using lectures, case studies, and hands-on work with realistic research materials, the in-person training expanded and developed further online learning. This study was designed to implement and evaluate a standardized competency-based training process for clinical research personnel. The method used was grounded in a collaborative approach leading towards generating best practices across research universities. Recognizing the need to tailor learning to adults, there has been a decided shift towards the use of problem-based learning guided by experiential learning theory (Jones, Jester, & Fitz-Gerald, 2010; Sternberg & Zhang, 2014). …

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