The competency index for clinical research professionals: a potential tool for competency-based clinical research academic program evaluation.

Background: Accreditation of graduate academic programs in clinical research requires demonstration of program achievement of Joint Task Force for Clinical Trial Competence-based standards. Evaluation of graduate programs include enrollment, student grades, skills-based outcomes, and completion rates, in addition to other measures. Standardized measures of competence would be useful. Methods: We used the Competency Index for Clinical Research Professionals (CICRP), in a separate-sample pretest-posttest study to measure self-confidence or self-efficacy in clinical research competency comparing cohorts of students entering and completing a master's degree program in clinical research across three semesters (summer 2021 - spring 2022). CICRP is a 20-item Likert scale questionnaire (0 = Not at all confident; 10 = extremely confident). Results: The study sample of 110 students (54 in the entry course, 56 in the exit course) showed overall 80.9% entered the program with only a baccalaureate degree and 55.5% had no prior experience in managing clinical trial research. Cronbach alpha for the instrument showed a high level of content validity (range 0.93-0.98). Median CICRP item rating range at entry was [1, 6] and at exit [7, 10]. Mean CICRP total score (sum of 20 items) at entry was 72.7 (SD 41.9) vs. 167.0 (SD 21.1) at exit (p < 0.001). Mean total score at program entry increased with increasing years of clinical trial management experience but attenuated at program exit. Conclusion: This is the first use of the CICRP for academic program evaluation. The CICRP may be a useful tool for competency-based academic program evaluation, in addition to other measures of program excellence.

The importance of developing a financial audit process: An academic medical center perspective.

Clinical research studies run the risk of being in a deficit leading to premature study termination or a desperate struggle to find new funding to continue the research. It is important for institutions, small or large, to have financial oversight during the research process. We created a financial audit process for a core clinical research department at a pediatric hospital. Understanding where to find your costs, what costs are important, and other elements of the audit process are essential. Knowing how to replicate a financial audit process can help you eliminate the risk of a financial deficit.

Increasing safe clinical spaces and the efforts of clinical research for uninsured and underinsured LGBTQIA2+ patients: A case study of the Rainbow Clinic - a student-run free LGBTQIA2+ clinic.

LGBTQIA2+ patients often experience discrimination and hostility in healthcare spaces. Negative perceptions of healthcare can contribute to poor health outcomes in LGBTQIA2+ patients. This population is rarely included in clinical trials through a lack of inclusion in study protocols, informed consent, and trials not addressing their needs and demographics. Many clinical institutions have created LGBTQIA2+-specific clinics; however, few have successfully developed a free clinic dedicated to this population. A Rainbow Clinic was formed at an established student-run free clinic, utilizing the existing infrastructure. Dissemination of this clinic's creation can help others replicate similar initiatives.

Diversity among research coordinators in a pediatric emergency medicine research collaborative network.

We conducted a survey study of clinical research coordinators (CRCs) at the member institutions of the Pediatric Emergency Care Applied Research Network, to determine the demographic and linguistic characteristics of CRCs around the network, and any perceived impact of those characteristics on their duties. A total of 53/74 CRCs completed the survey. Most respondents identified as "female," "white," and "not Hispanic/Latino." Most respondents felt that their race/ethnicity and their ability to speak a language other than English would positively impact recruitment. Four female respondents felt that their gender hindered their recruitment efforts and their sense of belonging within the research team.

Academic medical center clinical research professional workforce: Part 2 - Issues in staff onboarding and professional development.

Background: Defining key barriers to the development of a well-trained clinical research professional (CRP) workforce is an essential first step in identifying solutions for successful CRP onboarding, training, and competency development, which will enhance quality across the clinical and translational research enterprise. This study aimed to summarize barriers and best practices at academic medical centers related to effective CRP onboarding, training, professional development, identify challenges with the assessment of and mentoring for CRP competency growth, and describe opportunities to improve training and professionalization for the CRP career pathway. Materials/Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore the complex issues involved when developing high-quality onboarding and continuing education opportunities for CRPs at academic medical centers. Results: Results suggest there are several barriers to training the CRP workforce, including balancing foundational onboarding with role-based training, managing logistical challenges and institutional contexts, identifying/enlisting institutional champions, assessing competency, and providing high-quality mentorship. Several of these themes are interrelated. Two universal threads present throughout all themes are the need for effective communication and the need to improve professionalization of the CRP career pathway. Conclusion: Few institutions have solved all the issues related to training a competent and adaptable CRP workforce, although some have addressed one or more. We applied a socio-technical lens to illustrate our findings and the need for NCATS-funded academic medical centers to work collaboratively within and across institutions to overcome training barriers and support a vital, well-qualified workforce and present several exemplars from the field to help attain this goal.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences' Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.

Key ePortfolio features and strategies for student success in a competency-based clinical research program.

BACKGROUND: Student ePortfolios provide an interactive space for faculty, student peers, and potential employers to view skillsets and reflective expressions of students. EDUCATIONAL ACTIVITY: The adoption of ePortfolios in an interdisciplinary, competency-based, master's degree program in clinical research at a university in the Midwestern United States is described. Students submitted their ePortfolios as their culminating assessment. A survey was used to collect objective and open-ended responses from 104 students between 2015 and 2019 followed by a voluntary post-survey interview. Two ePortfolio platforms and instructional methods were compared. CRITICAL ANALYSIS OF THE EDUCATIONAL ACTIVITY: A user-friendly platform enhanced student engagement and reduced student and faculty frustration with the ePortfolio requirement. Thirty-seven students and alumni responded to an ePortfolio survey, and five students shared their experiences in a post-survey interview. Students described positive experiences related to their academic program and job search as a result of completing the ePortfolio. However, alumni were not strongly motivated to maintain their ePortfolio post-graduation. ePortfolios provide evidence of student acquisition of core competencies in a professional graduate degree. Facilitating the process of ePortfolio creation with instruction guides, exemplar ePortfolios, and an evaluation rubric support student success. A user-friendly ePortfolio platform with social media linking features will enhance exposure of the student's work to key stakeholders during and after their academic program. If the ePortfolio is to have an impact on a student's professional trajectory after graduation, it should contain meaningful examples of academic work that can be shared publicly and allow updating of ePortfolio content.

Creating and testing a GCP game in an asynchronous course environment: The game and future plans.

INTRODUCTION: The National Institute of Health has mandated good clinical practice (GCP) training for all clinical research investigators and professionals. We developed a GCP game using the Kaizen-Education platform. The GCP Kaizen game was designed to help clinical research professionals immerse themselves into applying International Conference on Harmonization GCP (R2) guidelines in the clinical research setting through case-based questions. METHODS: Students were invited to participate in the GCP Kaizen game as part of their 100% online academic Masters during the Spring 2019 semester. The structure of the game consisted of 75 original multiple choice and 25 repeated questions stemming from fictitious vignettes that were distributed across 10 weeks. Each question presented a teachable rationale after the answers were submitted. At the end of the game, a satisfaction survey was issued to collect player satisfaction data on the game platform, content, experience as well as perceptions of GCP learning and future GCP concept application. RESULTS: There were 71 total players who participated and answered at least one question. Of those, 53 (75%) answered all 100 questions. The game had a high Cronbach's alpha, and item analyses provided information on question quality, thus assisting us in future quality edits before re-testing and wider dissemination. CONCLUSIONS: The GCP Kaizen game provides an alternative method for mandated GCP training using principles of gamification. It proved to be a reliable and an effective educational method with high player satisfaction.