Objectives/Goals: Recognizing a critical need for sustained education and community beyond formalized training periods at Columbia University’s NCATS-CTSA, we created the TRANSFORM (TRaining And Nurturing Scholars FOr Research that is Multidisciplinary) Evolution program to preserve the networks cultivated during the KL2 program. Methods/Study Population: We will provide an overview of the genesis, expansion, key components, and programming for the TRANSFORM Evolution program. The program is designed for current and alumni of the KL2 program and late junior faculty that receive our CTSA’s Irving Scholar Award. TRANSFORM Evolution is a faculty and alumni network offering a platform to support the next generation of clinical and translational researchers while fostering a lasting community of collaboration and educational activities throughout a scholar’s career lifespan. Results/Anticipated Results: Salient components include the opportunities for social interaction, such as social/happy hours and member led education/career development sessions pertaining to topics that support thriving in an academic career. The program operates with financial resources and the support of a program manager. Evolution adopts a holistic, long-term approach, focusing on the entire professional lifespan by encouraging the development of enduring opportunities for our alumni. The program is intentionally structured to meet the evolving needs of its participants, through the beginning to more established phases in their professional careers. This continuity underscores the program’s capacity to adapt and remain relevant, informing and supporting sustained career progression and scholarly productivity. Discussion/Significance of Impact: The program has been an instrumental adjuvant in facilitating the transition to each career stage. By cultivating a community rooted in a common foundation – the KL2 and Irving Scholars programs, the program has created a robust support system that is crucial for the career development of clinician-scientists.

Significant improvements have been achieved to enhance the patient-centricity of clinical research, including the development and utilization of novel clinical trial endpoints. These include endpoints that harness outcomes that are important to patients and reflect the patients’ lived experiences. This may take the form of utilizing variables such as days alive and out of hospital (DAOH) and quality-of-life adjusted outcomes. The use of composite outcomes can be used to enrich patient-centricity by weighting or ranking events. These approaches have several nuances that should be considered including selecting appropriate events, defining outcomes, how to elicit or construct weights, and whose opinions to consider. After weights have been determined, a variety of approaches exist to combine weights with outcomes and make comparisons between groups. The approaches, including the win ratio, weighted win ratio, desirability of outcome ranking (DOOR), multicriteria decision analysis (MCDA), and variations of time-to-first composite event analyses, have unique advantages and challenges depending on the clinical scenario. While improving patient-centric outcomes is of high importance to multiple stakeholders, more comparative work is needed to characterize the implications of alternative approaches.

Objectives/Goals: Clinical trial success requires recruiting and retaining diverse participants. The ER&R Certificate Program trains clinical research professionals (CRPs) in equity, diversity, and inclusion (EDI), addressing biases, and integrating regulatory knowledge with practical skills to foster inclusive research practices. Methods/Study Population: An interdisciplinary Steering Committee, supported by Duke CTSI and DOCR, developed and implemented an engagement, recruitment, and retention certificate program (ER&R) for CRPs. With expert-led instruction, including e-learning, group sessions, and hands-on activities, ER&R integrates EDI into participant engagement practices. Participants complete 7 core courses and at least 3 elective courses, reflecting their unique responsibilities. Program evaluation uses the Kirkpatrick model to assess participant learning, competency, and EDI integration into clinical research. Since launch, the program has expanded to include clinical research trainees from Durham Technical Community College. All elements of the program were designed to allow for sharing across academic medical institutions. Results/Anticipated Results: A total of 202 CRPs and trainees have participated since launch (2020), including 17 trainee participants from Durham Technical Community College (2022–2024). Post-program evaluations showed significant growth in recruitment and retention self-efficacy. An early evaluation of the first 2 cohorts (n = 59) included a self-assessment across defined competencies showing marked increases in comfort across all learning objectives, with notable gains in: Community and Stakeholder Engagement, Recruitment on a Shoestring Budget, Community-Engaged Research Initiatives, and Social Marketing. Participants valued the program’s focus on EDI and sought more practical strategies and peer collaboration. 50 additional institutions have engaged with our implementation consultations and program repository. Discussion/Significance of Impact: Barriers to equitable ER&R exist at the individual, study, and system levels. Addressing these requires more intentional engagement practices. The ER&R certificate program is an innovative model for integrating equity principles with practical and required knowledge and skills training for participant-facing research professionals.

Women remain underrepresented in National Institutes of Health (NIH) study sections, panels of scientists who review grant applications to inform national research priorities and funding allocations. This longitudinal, retrospective study examined the representation of women on study sections before and during the COVID-19 pandemic. Overall, 16,902 reviewers served on 1,045 study sections across 2019, 2020, and 2021, of which 40.1% (n = 6,786) were women. The likelihood of reviewers being women significantly increased from 2019 to 2021, except among chairpersons. Understanding the representation of scientists influencing NIH grant decisions is important to ensuring scientific discovery that meets the nation’s pluralistic needs.

Objectives/Goals: The importance of interprofessional communication in healthcare is well documented. However, there has yet to be a theoretical framework for understanding this complex phenomenon. The purpose of this project was to develop a situation-specific theory about the culture of communication in the interprofessional healthcare setting. Methods/Study Population: We conducted individual virtual qualitative interviews with 16 healthcare professionals at different levels and from various disciplines. Participants were practicing clinicians at a tertiary care academic medical center. We transcribed audio-recordings of the interviews verbatim and aligned each transcript for accuracy, confidentiality, and representativeness. Data analysis was conducted using dimensional analysis, including open- and theoretical-coding utilizing an explanatory matrix for theory generation. Results/Anticipated Results: Our findings produced a situation-specific theory on the culture of interprofessional communication in the healthcare setting. Participants described the environments in which they practiced in terms of hierarchical system structures and through a conceptual perspective of resource investment. In other words, they viewed their time and their effort as valuable – and notably, scarce – resources, which they invest in patient care, interprofessional communication, and other tasks. There are two key pathways that characterize the culture of interprofessional communication: collaborative communication and transactional interactions, depending on whether an individual perceives the goals of another person, department, or level of the hierarchical institution as aligned with their own goals. Discussion/Significance of Impact: Positive cultures of interprofessional communication in the healthcare setting depend on perceived goal alignment among individuals, departments, and leadership. Future research can explore how perceptions of goal alignment are developed and empirically test this situation-specific theory in other healthcare system settings.

Objectives/Goals: This poster describes the scientific rationale, needs assessment, programmatic elements, and impact of a community of practice (CoP) focusing on advancing equity in the science and practice of mentorship. Methods/Study Population: In 2023, the University of Wisconsin Institute for Clinical and Translational Research received NIH R13 funding to host a conference, the Science of Effective Mentorship (Asquith, McDaniels, et.al., 2023). Approximately 150 researchers and program leaders from Clinical and Translational Science Awards (CTSA) Hubs and beyond attended. Data were collected before, during, and after the conference, providing the authors with an initial idea of community needs. As a result, a mentorship CoP was formed. In the subsequent 18 months, a steering and advisory committee established a program of virtual, topic-focused virtual events every 3 months as well as a community website, with increasing attendance and utilization. A survey was disseminated after the completion of one year, and a focus group was held during the last virtual gathering. Results/Anticipated Results: The demand for infrastructure to support a national community of practice will be demonstrated. The demographic and positional diversity (e.g. role within a CTSA Hub) will highlight the opportunities of convening this diverse community. Organizational challenges and opportunities will be highlighted. Assessment data will reveal the broad range of needs and interests of participants. Aggregate demographic, professional, and participation data about community of practice members will be shared, as well as the governance and programmatic elements of this community of practice. Evaluation results from the first year of activity will be displayed. Needs for sustainability will be discussed. Discussion/Significance of Impact: CoPs are not new in the CTR space. Membership in a CoP may reduce isolation individuals feel as they negotiate the important work of equity in the biomedical workforce. Members of this community of practice share the expertise and commitment to promoting equity in the biomedical workforce through supporting robust culture of mentorship.

This paper describes the development and initial implementation of the Compendium of D&I Catalogs, a tool created by a Clinical and Translational Science Awards (CTSA) consortium working group to streamline navigation of the proliferating online resources, catalogs and interactive tools designed to guide application of dissemination and implementation (D&I) science. The Compendium is a curated, dynamically-updated list of 35 D&I resource catalogs organized into eight categories: comprehensive resources; frameworks, theories, and models; methods and measures; funding; practitioner resources; training; CTSA infrastructure; health equity. Eight CTSA hubs volunteered to serve as “early adopters” for the tool and completed an evaluation of its initial implementation. Among these “early adopters,” half had implemented the Compendium within their websites, describing the web implementation process as “easy.” Remaining “early adopter” respondents cited institutional web development capacity concerns and competing priorities as reasons for delayed implementation. All respondents valued the Compendium’s dynamic updates. Among implementing sites, roughly two-thirds directly embedded the Compendium into their institutional websites, with the others providing a link to the Compendium. For CTSAs striving to meet the rising demand for D&I expertise and resources, the Compendium of D&I Catalogs represents a simple, low-cost tool to enhance accessibility of D&I capacity-building resources.

Objectives/Goals: Clinical research professional (CRP) managers often struggle to onboard effectively in the rapid timelines necessary. We developed a competency-based, standardized, onboarding program using a 3-factor adult learning approach and designed to be easily adaptable, broadly shared, and readily implemented across a variety of research environments. Methods/Study Population: The Duke competency-based onboarding program for CRPs was developed through an iterative process with input from research community members. Initially, 97 courses were mapped to clinical research competencies using the Joint Taskforce for Clinical Trial Competency framework to identify training gaps and establish a structured learning framework. The onboarding program includes three key components: role specific Express Start modules (self-paced e-learning), Onboarding Learning Plans (a customizable timeline for competency-mapped trainings), and Engagement Activity Packets (guides for manager-driven applied learning in specific competency areas). An additional cohort-based mentorship program (RPN+) includes 4 months of mentored group learning and seminars designed for new professionals. Results/Anticipated Results: Since launch in 2021, 521 new employees have registered an Onboarding Learning Plan representing more than 55% of new CRPs. Additionally, nearly 85% of new CRPs have completed the Express Start role-specific online modules. 54% of new CRPs have enrolled in RPN+ (launched in 2022) and have included members from 22 of 24 clinical research units. Users have reflected the range of clinical research staff roles at Duke, with the majority being clinical research coordinators. A significant predominance of participants found the programs beneficial and would recommend to others. Since launch, program materials have been shared with 64 external groups and institutions via 91 requests. Discussion/Significance of Impact: Duke’s CRP onboarding program addresses organizational, technical, and social aspects through Express Start, Onboarding Learning Plans, and the RPN+ mentoring program. Aligned with the JTFCTC framework, and designed for broad implementation, it successfully promotes competency-based growth and optimizes time for both managers and employees.

Objectives/Goals: A summer research program for medical students was implemented using real-world evidence (RWE) – electronic health record (EHR) databases to develop and answer research questions. Medical students were trained in capabilities of traversing the large RWE-EHR so they may query, extract, and analyze data as well as refine their research questions. Methods/Study Population: Ten medical students and 9 non-data scientist mentors underwent training in how to use the IU School of Medicine-Evansville RWEdataLab (CRC/Sidus Insights) national real-world cardiology and psychiatry deidentified EHR databases. The program began with students attending introductory training teaching database, spreadsheet, and statistical program usage. During the remainder of the program, a weekly best practices meeting took place among mentors and a weekly cohort meeting of students and mentors discussed student presented findings. At the end of the program, students generated abstracts and poster or podium presentations to share their findings at local symposia. A survey was also distributed to students to assess the impact of the tools, trainings, and program. Results/Anticipated Results: All students were able to define a question of interest, query and extract data related to their research question, and analyze multiple aspects of their data. Projects were well received at local symposia, with 2 receiving special honors, and 2 projects have been presented at regional/national conferences. Students rated the program highly and were likely to recommend the program to other students. They self-rated improvements in asking scientific questions, using excel, data presentations, and problem-solving. Students valued weekly “check-in” meetings and interactions with mentors more than lectures or technical “help desk” support. Discussion/Significance of Impact: The program provides mechanisms for non-data scientists and medical trainees, to learn and access RWE-EHR databases to address research questions. The cohort interactions fostered discussion among mentors and students promoting research question refinement and clarity findings. The program also introduces a new tool for potential patient care.

Current evidence underscores a need to transform how we do clinical research, shifting from academic-driven priorities to co-led community partnership focused programs, accessible and relevant career pathway programs that expand opportunities for career development, and design of trainings and practices to develop cultural competence among research teams. Failures of equitable research translation contribute to health disparities. Drivers of this failed translation include lack of diversity in both researchers and participants, lack of alignment between research institutions and the communities they serve, and lack of attention to structural sources of inequity and drivers of mistrust for science and research. The Duke University Research Equity and Diversity Initiative (READI) is a program designed to better align clinical research programs with community health priorities through community engagement. Organized around three specific aims, READI-supported programs targeting increased workforce diversity, workforce training in community engagement and cultural competence, inclusive research engagement principles, and development of trustworthy partnerships.

Objectives/Goals: Engage the research professional (RP) workforce in assessing job satisfaction, motivators, barriers, and levels of support throughout the research enterprise. The goal of this collaboration is to foster a positive culture, inform manager training, ensure RP retention, and enhance career mobility pathways. Methods/Study Population: Methods include a HR data compilation/analysis and focus groups for new RP’s (Results/Anticipated Results: This initiative will articulate the current culture and climate of the research enterprise and identify key strategic areas for growth. The UMN Clinical and Translational Science Institute (CTSI) will build off the design of an internal survey at Vanderbilt (2018) to encompass organization-specific challenges, the post-pandemic research landscape, and the UMass Diversity Engagement Survey. This process will also generate specific insights including RP sentiment statements, trends in how RP’s describe their day-to-day work, assessment of barriers, analysis of retention benchmarks, and defining employee hopes/motivators. The CTSI will also identify salient RP growth opportunities, leadership competencies, and areas of non-monetary compensation to improve satisfaction and career mobility. Discussion/Significance of Impact: Targeted interventions will be developed to address RP satisfaction barriers and leverage opportunities for KPI improvement. Results will be disseminated to managers, administrators, and the CTSI network. Resource development will include RP personas, job description/hiring templates, and strategic guides for key operational challenges.

Recent years have seen increasing focus, including by the National Institutes for Health (NIH), on developing the field of translational science (TS). TS focuses on improving the process of translational research (TR), including generating knowledge that can facilitate TR across specific diseases or translational stages. With TS as an emerging field, research organizations have an increasing need to understand how to develop capacity for and support the advancement of TS. To support such institutional and infrastructural change, this paper outlines a Translational Science Promotion and Research Capacity (T-SPARC) Framework. The T-SPARC Framework provides a foundation to 1) inform the development of TS-creating and science-supporting interventions and programs, and 2) examine the effectiveness of said interventions and programs. The framework outlines organizational levels that T-SPARC programs can target; mechanisms, or intervention activities, that can foster change; and outcomes, including specific attitudinal or behavioral changes, institutional changes, and domains on which TS changes can focus. T-SPARC’s capacity-building focus builds upon earlier efforts focused on conceptualizing and defining TS. T-SPARC supports movement towards TS goals of reducing longstanding challenges in the TR process, thus accelerating the health impact of TR, and ultimately improving health outcomes.

Objectives/Goals: The ITHS KL2 Seminar Fellows program creates a larger cohort by inviting additional early career faculty to join the tailored career development curriculum. The implementation of this program seeks to increase collaboration and innovation by amplifying diverse perspectives and increased networking. Methods/Study Population: In addition to the funded KL2 Scholars awarded each year, 13–15 Seminar Fellows are invited to be full participants in the KL2 curriculum, which includes monthly career development seminars and opportunities for feedback on their research. Invited Fellows are early career investigators who were promising KL2 applicants, faculty with alternative career development funding, and/or new underrepresented faculty in Washington, Wyoming, Alaska, Montana, and Idaho. Fellows commit to one year of participation, which can be renewed on a case-by-case basis. Fellows have been integrated into the ITHS implementation of Flight Tracker (Vanderbilt) to follow the career pathways alongside funded KL2 award recipients. Results/Anticipated Results: The key measures of success will be the rate of seminar fellows transitioning into K-level or similar career development awards and securing other subsequent funding. Preliminary data demonstrates significant collaborations between KL2 Scholars with different areas of scientific inquiry and promotion of at least half of our past KL2 Scholars into leadership positions at prestigious medical schools in the USA and Canada. We suspect that the trends evidenced by the career progression of early KL2 recipients will be expanded into newer and different translational research projects with the addition of the KL2 Fellows program. Discussion/Significance of Impact: The Seminar Fellows program presents a cost-effective way to increase the impact of an existing career development program by amplifying cross-boundary interactions to form a strong, diverse translational research workforce.

Objectives/Goals: We developed an educational online module to equip researchers with knowledge, skills, and resources for conducting community-engaged research, aiming to foster meaningful collaboration between academia and communities. Methods/Study Population: A working group was formed, including three research faculty, four staff members, and four community partners who have partnered with researchers on community engaged projects. The working group first identified three objectives for the module and outlined what should be covered for each objective. The working group identified existing resources, texts, and videos that would address the objectives and worked in small groups to create additional content for the module. A smaller subgroup then took this content, organized it, and worked with the Office of Online Education to put the content into an interactive online format. Results/Anticipated Results: The three objectives identified for the online module are 1) Describe community engaged research, the purpose it serves, and why researchers do it; 2) Identify how to seek and collaboratively engage with a community partner; and 3) Identify and connect with resources for conducting community engaged research in Indiana. Each objective contains text, interactive figures and images, links to external resources or further reading, and videos of researchers and community partners talking about their own experiences and lessons learned. Each objective also includes activities and prompts for the learner to complete to apply the module content to the work they want to do. Discussion/Significance of Impact: Community engagement ensures research addresses real-world needs, builds trust, and includes diverse perspectives. Many researchers lack best practices to do this ethically. This module teaches skills needed to foster trust through transparency, respect, and by incorporating community voices.

Objectives/Goals: Goals for this work include identifying areas for continuous curricular improvement as well as documenting best practices in multidimensional mentoring in innovation. Programmatic goals include pivoting early career scientists toward translational science solutions that are commercially viable. Methods/Study Population: Using Likert-scaled perception surveys of fellowship participants, preliminary pre- and post-fellowship responses are presented. Preliminary regression analyses are used to identify trends in participants’ ratings across innovation pathways and customer-focused design. Results/Anticipated Results: Focusing on the initial cohort of fellows’ perceptions of their competencies in the areas of technology propositions and industry networking, we observed a near twofold improvement reported competency, suggesting a key strength area for the Fellowship program. Discussion/Significance of Impact: First of its kind at Penn State College of Medicine, the Center for Medical Innovation’s partnership with Clinical and Translational Science Institutesignals enhanced commitment to developing early career fundamental scientists in the areas of intellectual property, customer-focused design, and commercialization. Significance of this work includes capturing best practices.