OBJECTIVES/SPECIFIC AIMS: Biostatistics and Epidemiology courses within clinical research or public health training programs are typically developed and taught separately. As a result, students may have trouble in their research outside the classroom, where biostatistical and epidemiological concepts must be well integrated. Case method teaching is a participant- and discussion-centered pedagogical approach that has been used in business and law schools for more than 50 years to improve student learning, yet has taken longer to be adopted in health professional schools. The case method is distinguished by presenting learners with a real-world problem without a single unique solution. Designed to mimic the constraints and incomplete information found in real life, it is an ideal approach for integrating multiple related disciplines. A team of Clinical and Translational Science (CTS) faculty from the Tufts CTSI collaborated to develop a new course that integrates epidemiology and biostatistics disciplines using the case method. METHODS/STUDY POPULATION: We developed an intermediate-level, case-based course integrating epidemiology and biostatistics topics using modern, real-world clinical examples. Recognizing the importance of technical skill building, this intermediate-level Tufts CTS course adopted a hybrid approach, incorporating lecture and in-class laboratory exercises, alongside cases. We surveyed CTS faculty to identify a set of core methodological competencies. These included randomized trials, case-control and cohort studies, confounding, effect modification, propensity scores, linear and logistic regression, and survival analysis. Faculty provided us with clinical questions and deidentified data sets corresponding to these competencies; we also reviewed publicly available data sets. RESULTS/ANTICIPATED RESULTS: CTS faculty collaborated to develop 10 cases (with accompanying data sets) from modern clinical research examples that illustrate the connections between epidemiology and biostatistical concepts. Each case contains a background section, a statement of the core problem, a data set with data dictionary, articles from the primary literature (often the publication of the data set) with discussion questions and in-class lab exercises (R programming). One case presents students with the challenge of whether acupuncture may be an effective therapy for pain associated with chronic headache. Through case activities, students gain experience weighing observational Versus experimental evidence, apply directed acyclic graph theory, and analyze clinical trial data. Qualitative evaluations in 2015 (pilot year) and 2016 indicate students preferred the integrated approach to separate courses, and found the integration facilitated application of methods to their independent research projects. Significant rewards for faculty include cross-disciplinary collaboration, sharpened teaching skills, and engaging with learners in a dynamic classroom environment. DISCUSSION/SIGNIFICANCE OF IMPACT: Despite administrative and pedagogical challenges, a case-based, integrated curriculum offers rewards for faculty and students. The case method may be a useful pedagogical strategy to integrate other closely related topics or courses in translational science to better prepare scholars for the challenges of independent research.

OBJECTIVES/SPECIFIC AIMS: Describe the process used to develop job descriptions and how this translates into consistent hiring practices. Describe how competencies are used to provide transparency into professional development opportunities. Discuss planned incorporation of competencies into efforts to train the clinical research workforce. METHODS/STUDY POPULATION: These processes were developed at Duke, an academic medical center with over 2000 active clinical research protocols and 300 new clinical trials per year. Over 1000 employees were evaluated for mapping into clinical research positions, with 685 mapping into new research positions (makeup of workforce to be depicted). RESULTS/ANTICIPATED RESULTS: Prior to this initiative, the clinical research workforce was not well-defined. Through the mapping process, employees were mapped from over 80 different positions into 10 (figure), resulting in a workforce that allows for visible career ladders and greater opportunity for development. As the initiative evolves and grows to include competency-driven performance evaluations, training modules, and assessments, we anticipate the ability to see the relationship between the competencies and high-quality clinical research support. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of competencies in the context of workforce development is not new, yet in clinical research, they provide a much-needed framework for an ever-evolving profession. This comprehensive use of competencies throughout a workforce development initiative is key to ensuring strong support of high-quality clinical research.

OBJECTIVES/SPECIFIC AIMS: We aim to leverage our analysis of the scientific collaboration network at a research university to design an innovative pilot program and foster scientific productivity. We test the impact of creating a new collaboration in a research community, which decreases the average network distance and accelerates the diffusion of information and expertise among the community’s investigators. METHODS/STUDY POPULATION: We mapped the whole network of co-authorship on publications and co-participation on extramurally awarded grants at the University of Florida (UF) between 2013 and 2015. We used network science methods to identify research communities of investigators who have consistently worked together and/or have other collaborators in common with at least one researcher based in the UF Health Science Center. We selected pairs of communities with (i) similar productivity levels, research interests, and network structures and (ii) no research projects in common. Communities in each pair were randomly assigned to a treatment or control group. In each treatment community, we selected 1 pair of investigators who had not collaborated in the past 3 years and whose connection would maximally reduce average network distance in the community. The pair was provided with an economic incentive to collaborate for the submission of a CTSA pilot proposal. RESULTS/ANTICIPATED RESULTS: We successfully identified 15 pairs of treatment/control communities. In each of 8 treatment communities, a pair of potential collaborators agreed to participate in the intervention. DISCUSSION/SIGNIFICANCE OF IMPACT: Network-informed Clinical Translational Science Awards (CTSA) pilot programs can identify research communities and create innovative collaborations. Statistical experiments can establish the programs’ causal effects on scientific productivity.

OBJECTIVES/SPECIFIC AIMS: HIV is a chronic disease that affects the immune system. HIV+ people live more thanks to effective antiretroviral treatments. The scientific data demonstrate that HIV+ is associated to the cognitive impairment presented in the 50% of the patient. The objective of this study is to determine the correlation between emotional dysfunction and perceived stigma in HIV+ women and its effects HIV-associated neurocognitive disorders (HAND). METHODS/STUDY POPULATION: HIV+ women will be recruited form the Hispanic Longitudinal Cohort and evaluated questionnaires for emotional dysfunction and stigma, neuropsychological tests, and MRI. RESULTS/ANTICIPATED RESULTS: We anticipated that women with HIV+ will experience higher levels of emotional dysfunction (ie, fear) and perceived stigma when compared with the control group. Women with HIV infection will present an association between emotional dysfunction most like fear and perceived stigma when compared with the control group. This correlation will be associated with HAND. The women with HIV infection will present circuit integrity dysfunction associated with emotional dysfunction and perceived stigma as determined by DTI and connectivity (MRI). DISCUSSION/SIGNIFICANCE OF IMPACT: HIV stigma and emotional dysfunction have a negative impact in quality of life (QOL). This effect can be improved with several treatment interventions with eventual improvement in adherence, emotional control, and QOL.

OBJECTIVES/SPECIFIC AIMS: Knowing how to deliver culturally responsive care is of increasing importance as the nation’s patient population diversifies. However, unless cultural competence is taught with an emphasis on self-awareness (Wear, 2007) and critical consciousness (Kumagai and Lypson, 2009) learners find this education ineffective (Beagan, 2003). This study examines how physicians perceive their own social identities (eg, race, socio-economic status, gender, sexual orientation, religion, years of experience) and how these self-perceptions influence physician’s understandings of how to practice culturally responsive care. METHODS/STUDY POPULATION: This exploratory study took place at a university in the Intermountain West. We employed a qualitative case study method to investigate how academic physicians think about their identities and approaches to clinical care and research through interviews and observations. In total, 25 participants were enrolled in our study, with efforts to recruit a diverse sample with respect to gender and race as well as years of experience and specialty. Transcriptions of interviews and observations were coded using grounded theory. One major code that emerged was defining experiences: instances where physicians reflected on both personal and professional life encounters that have influenced how they think about themselves, how they understand an aspect of their identity, or why this identity matters. RESULTS/ANTICIPATED RESULTS: Two main themes emerged from an analysis of the codes that show how physicians think about their identities and their approaches to practice. (1) Physicians with nondominant identities (women, non-White) could more easily explain what these identities mean to them than those with dominant identities (men, White). For example, women in medicine had much to say about being a woman in medicine, but men had barely anything to say about being a man in medicine. (2) There was a positive trend between the number of defining experiences a physician encountered in life and the number of connections they made between their identities and the manner in which they practiced, both clinically and academically. It appeared that physicians who have few defining experiences made few connections between identity and practice, those with a moderate number of experiences made a moderate number of connections, and those with many experiences made many connections. Physicians who mentioned having many defining experiences were more likely to be able to articulate how those experiences were incorporated into their approaches to patient care. DISCUSSION/SIGNIFICANCE OF IMPACT: (1) According to literature in multicultural education, those with dominant identities do not think about their identities because they do not have to (Johnson, 2001). One privilege of being part of the majority is not having to think about life from a minority perspective. This helps to explain why women and non-White physicians in this study had more anecdotes to share about these identities—because they have had defining experiences that prompt reflection on these identities. (2) We propose that struggles and conflict are what compel physicians to reflect on their practice (Eva et al., 2012). Our findings suggest that physicians are more prepared to apply what they have learned from their own identity struggles in delivering culturally responsive care when they have had more opportunities to reflect on these identities and situations. Findings from this study have implications for transforming approaches to medical education. We suggest that medical education should provide learners with the opportunity to reflect on their life experience, and that providers may need explicit instruction on how to make connections between their experiences and their practice.

OBJECTIVES/SPECIFIC AIMS: To conduct a preliminary evaluation of the Social and Behavioral Research Best Practices Course. METHODS/STUDY POPULATION: Learners are sampled from 5 institutions: University of Michigan, University of Rochester, University of Florida, Boston University, and University of Buffalo. Learners who take the course and consent to be in the study receive a web link to a survey immediately after course completion and at 2–3 months follow up. In addition to demographic information, learners will report their perceptions of usefulness and relevance of the course to their job, their satisfaction with the course and associated job aids, and at follow-up, if and how the course impacted their work. Additional information will be collected from the learning management systems which host the course at each institution. The data collected will include the number of participants who take the course, the number who complete, how many times the course was attempted, and pass rates. RESULTS/ANTICIPATED RESULTS: We anticipate that several hundred learners will take the course by the end of our project. Of learners who agree to participate in the survey, we anticipate that they will find the course useful and relevant to social and behavioral clinical trials and will be satisfied with the course. Information including suggestions about missing content, items or content that were not extremely clear, or any other comments will be collected to iterate and expand the course. DISCUSSION/SIGNIFICANCE OF IMPACT: This course was developed to fill a gap in training in good clinical practice for social and behavioral research. An evaluation of how the training provided in the course impacts the jobs of learners is needed both to ensure that the most relevant information is included in the course as well as to identify ways that the training may contribute to the quality and safety of social and behavioral clinical trials.

OBJECTIVES/SPECIFIC AIMS: Compare effectiveness of a patient case-based, interactive teaching approach that included optional student genotyping with traditional didactic teaching strategies for increasing students’ knowledge and ability to effectively use pharmacogenomic data in clinical decision making. METHODS/STUDY POPULATION: The UF College of Pharmacy offers a required Personalized Medicine (PM) course for pharmacy students as well as an elective course, Clinical Applications of Personalized Medicine (CAPM). Students dual enrolled in the PM and elective CAPM courses comprised the intervention (INT) group, with interactive patient case-based teaching and the option to undergo personal genotyping, whereas students enrolled in PM alone comprised the control (CTR) group, which primarily used a traditional didactic teaching format and did not include personal genotyping. Both groups completed a pre- and post-course patient case-based test (15 questions/1 point each) to evaluate their knowledge and abilities to apply genotype and other patient-specific data to drug therapy recommendations. Pre- and post-course test scores for knowledge were compared between the INT and CTR groups using the Student t-test. RESULTS/ANTICIPATED RESULTS: In total, 52 students completed surveys (INT group, n=21; CTR group, n=31). Race was similar between groups, but there were fewer females in the INT compared with CTR group (8 vs. 22, p=0.02). Pre-course knowledge scores did not differ between INT and CTR groups (6.8±2.2 vs. 6.3±1.6 respectively, p=0.34), however, post-course scores were significantly higher in the INT Versus CTR group (10.0±2.3 vs. 7.5±1.7, p<0.0001). DISCUSSION/SIGNIFICANCE OF IMPACT: There have been significant advancements in the clinical applications of pharmacogenomic and genomic data, however, barriers to routine clinical adoption of genomic medicine persist. Developing education and training methods that equip practitioners to effectively translate genomic data into evidence-based clinical recommendations has been identified as a key strategy to overcome such barriers. Our data suggest that a personalized medicine course that employs patient-centered, case-based teaching strategies and includes optional personal genotyping for students compared with traditional didactic instruction improves students’ knowledge and abilities to apply pharmacogenomic data in practice-based scenarios. These results can inform future strategies for educating healthcare professionals on the clinical use of pharmacogenomic and genomic data.

OBJECTIVES/SPECIFIC AIMS: The first goal of this project is to test the reliability and validity of an objective structured clinical exam (OSCE) that was designed to assess competency in clinical and translational research. The second goal is to evaluate the impact of MICHR’s Summer Research Program on the participating trainee’s competency development. METHODS/STUDY POPULATION: The methodology used for this study was reviewed and exempted from oversight by the U-M Institutional Review Board (HUM00113293). The participants in the study include 17 pre-doctoral students in health professions programs at U-M who participated MICHR’s Summer Research Program. The Research OSCE was administered using a pretest, post-test design. The pretest was administered once during the 1st week of program in the Summer of 2016 and the post-test during the 10th week of the program. The Research OSCE was proctored and rated by trained staff members. We will assess the reliability of the Research OSCE using Generalizability Theory (Webb et al., 2006). And the construct validity of the Research OSCE will be tested using factor analysis and other statistical analyses. Growth in the competence of the trainees participating in the Summer Research program will be evaluated by testing for significant differences between their pretest and post-test scores. RESULTS/ANTICIPATED RESULTS: We anticipate that this study will show that the Research OSCE is a reliable competency assessment with proven construct validity. We also anticipate that the use of the Research OSCE will show the trainees participating in the Summer Research program experienced a gain in competence during the course of the 10-week program. DISCUSSION/SIGNIFICANCE OF IMPACT: This project uses a common and standardized testing approach. The primary goal of this project is to evaluate the reliability and validity of an OSCE to assess competency in clinical and translational research. It represents a new application for a well-studied testing method used extensively in the health professions to assess the clinical competency of health practitioners. This project will lead to a better understanding of (a) the reliability and validity of the Research OSCE designed to test research competency and (b) the effectiveness of the Summer Research Program curriculum in better preparing participants to conduct clinical and translational research. Showing how a specific competency assessment can be used for this purpose will provide the administrators, evaluators, and other stakeholders of clinical and translational research training programs with information that can be used to design more rigorous and relevant evaluations of their research training programs.

OBJECTIVES/SPECIFIC AIMS: More partial nephrectomies are performed every year as a surgical treatment for kidney cancer. However, this procedure remains technically challenging. Surgeons require a substantial number of cases before their performance plateaus. No established practice mode exists; thus, there is a need for training models to simulate real tumor excisions and kidney suturing. In this study, we seek to validate these silicone models using multiple simulations with urologists of different training levels. METHODS/STUDY POPULATION: We created silicone renal tumor models using 3D printed molds of a patient’s kidney with a mass. Medical students, urology residents, fellows, and attending surgeons are recruited to perform simulated partial nephrectomies on these models. Four trials are performed with a da Vinci surgical robot on 2 different days. We are evaluating surgeon performance and improvement using validated measures as well as operation-specific metrics. Operation-specific metrics include renal artery clamp time and surgical margins. Validated measures of self-assessed operative demand (NASA TLX) and reviewer-assessed surgical performance (GEARS) are also recorded across trials. RESULTS/ANTICIPATED RESULTS: The preliminary results of 2 medical students, 10 urology residents, 3 endourology fellows, and 2 attending urologists are reported here. Model face validity was evaluated on a 0–100 sliding scale anchored at unrealistic and realistic. Mean results thus far are 77.7 for overall feel, 82.7 for needle driving, 75.6 for cutting, and 73.2 for visual representation. Between trials 1 and 4 there was a mean reduction of 3.26 minutes in renal artery clamp time, and a 75% reduction in positive margins. There was a reduced incidence of positive surgical margins with advanced training stage. Fellows, residents, and medical students had positive tumor margins in 25%, 50%, and 75% of their trials, respectively. We expect to recruit 15 additional subjects for this study. Upon completion of data acquisition, more robust statistical comparisons and measures will be reported. DISCUSSION/SIGNIFICANCE OF IMPACT: Face validity measures indicate the model adequately represents reality. Preliminary data suggest improved surgical performance over the course of the training and better performance in urologists of higher training levels. This model may have potential for broader application and integration into minimally invasive surgery training programs.

OBJECTIVES/SPECIFIC AIMS: Stakeholder and community engagement (SCE) is a national priority for the National Center for Advancing Translational Science (NCATS). An established framework for stakeholder engagement exists for the latter stages (T2-T4) of translational, but no such framework currently exists for early stages of translational science (T1). Four Clinical and Translational Science Award (CTSA) hubs launched a collaboration to develop a new framework for engaging communities and stakeholders in T1 research. METHODS/STUDY POPULATION: We led structured individual and group discussions with T1 investigators to learn about: (1) the health decisions they seek to inform with research evidence, (2) the actors who make those decisions, and (3) the individuals and organizations that are affected by those decisions. In total, 18 individuals connected to 4 CTSA hubs participated in the discussions. Participants came from the fields ranging from basic chemistry and drug development to infectious disease and pediatrics and represented both methodological and topical experts. Focus groups lasted, on average, 1 hour, were audio recorded. Interviews lasted ~30 minutes. Audio recordings were transcribed and deidentified, and transcripts were coded using Dedoose™. We used a deductive-inductive procedure to develop the framework for stakeholder engagement in T1 research. A deductive codebook was development from the focus group and interview guides; emergent themes were added and the codebook was revised after preliminary inductive analysis. Two coders analyzed all transcripts using a constant comparison approach. We used an inductive process to identify themes and form them into a framework that could be used by T1 researchers in their work. The framework was developed through sequential reviews with coauthors and research participants. RESULTS/ANTICIPATED RESULTS: Preliminary findings suggest that stakeholders in early stage translational research (T1) do not fit into the same framework as those further down the translational spectrum (T2-T4). Basic scientists can identify stakeholders, however, and would like more guidance on who, how, and when to engage them in their research. DISCUSSION/SIGNIFICANCE OF IMPACT: By showing T1 researchers how to identify and involve their stakeholders in (1) defining research questions, (2) carrying out research activities, and (3) disseminating research evidence, this work has the potential to improve the use of basic science evidence in latter stages of translation from bench to bedside.

OBJECTIVES/SPECIFIC AIMS: Provide an innovative, integrative, and interdisciplinary training program which will leverage a unique and internationally recognized strength of BU and establish an environment that facilitates translational team science interactions with MD scientists and clinicians, thereby synergistically bridging research strengths with interdisciplinary approaches. METHODS/STUDY POPULATION: This overall mission of the RMTP is pursued through 2 independent aims. Aim 1: Provide an innovative, integrative, and interdisciplinary training program which will leverage a unique and internationally recognized strength of BU. Aim 2: Establish an environment that facilitates translational team science interactions with MD scientists and clinicians, thereby synergistically bridging research strengths with interdisciplinary approaches. To achieve these aims, we have developed a specialized didactic curriculum that is fully integrated in graduate school training and can be shared for the benefit of others outside of the BU community. We are also developing online iPSC practicum workshops for more efficient distribution of didactic content. Interdisciplinary team science approaches to stem cell research related to cures for human diseases are fostered across investigators across diverse hubs at BU, BU Medical Center, the Charles River Campus and the Framingham Heart Study. All methodology, data and materials are provided in a transparent and open-source manner to benefit the greater scientific community and ensure rigorous reproducibility. RESULTS/ANTICIPATED RESULTS: As a nascent TL1 training program, we are just arriving at the end of our second year. At this point, 5 out of a total of 11 appointed trainees have concluded RMTP support, all of whom have transitioned into biomedical science-related pursuits; 2 predoctoral trainees were awarded F31 fellowships, 2 postdoctoral trainees were awarded career transition grants (K99/R00 and LERN fellowship), and 1 postdoctoral trainee became a Senior Scientist at a Biopharmaceutical company. Given the quality of our trainees and their RMTP mentors, we anticipate that close to 100% of those supported by this mechanism will continue their career development in the biomedical sciences. DISCUSSION/SIGNIFICANCE OF IMPACT: Implementation of the RMTP TL1 would not only serve to increase the capacity of trainees within the CReM, but would also extend the scope of regenerative medicine research to other CTSI-participating hubs and more broadly to other scientific disciplines.

OBJECTIVES/SPECIFIC AIMS: To improve translational research, we have developed a program called Duke Multidisciplinary Education and Research in Translational Sciences (Duke MERITS). Duke MERITS will facilitate cross-disciplinary collaboration among faculty involved in foundational, clinical and/or health care research and in turn also prepare them to train the next generation of translational researchers. METHODS/STUDY POPULATION: The program aims are (1) to define metrics and outcomes measures so faculty can track their progress and identify impact of their collaborative research in translational sciences; (2) to offer a multi-modal faculty development series to promote team science, improve didactic teaching, and incorporate innovative resources to promote interdisciplinary approach to translational research; (3) to provide module-based hands-on-training sessions in bench to bedside research and training in translational grant writing to facilitate the development of multidisciplinary research collaborations. The present study describes results from Aim 1 and includes (a) development of baseline outcome assessment tools necessary to gauge the impact of our programs on both the participating faculty and the research culture within Duke University, (b) impact of a specific course offering in Translational Medicine. In order to achieve this, we conducted multiple focus group sessions with faculty self-identified as junior-, mid-, or advanced-career, a mixed group at any career level and included a group of graduate students and postdoctoral trainees to study the impact of a graduate level course in Translational Aspects of Pathobiology. The activities during these translational science focus groups were designed to define what successful translational science is, to determine what resources support translational Science at Duke, and to decide what resources we need in order to enhance Duke’s position as a leader in research and scientific education. RESULTS/ANTICIPATED RESULTS: We identified that translational science is changing standards while incorporating leadership, teamwork, collaborations, and movement primarily focusing on the overall goal of improving all aspects of health. Participants categorized their field of study and the fields of their coparticipants most frequently as basic discovery and a combination of intervention and health services. The most frequently identified pros/benefits of performing translational science at Duke include industry connections, collaborations with other departments resulting in disciplines being bridged, improving patient care, and access to resources as well as money. The most frequently identified cons/barriers of performing translational science includes the expensiveness, silos, and lack of resources willing to absorb risks. DISCUSSION/SIGNIFICANCE OF IMPACT: The identification of these defined factors from the focus groups has allowed us to issue a comprehensive, sliding Likert scale-based anonymous survey from the secure RedCap system and is being rolled out throughout Duke University, including schools of medicine, nursing, Trinity, biomedical engineering. We envision that Duke MERITS education program will facilitate interprofessional efforts, which we define as a team science approach to identify the clinical “roadblock” and then seek an innovative approach or technology to help overcome this “roadblock”? It can facilitate institutional and departmental recognition in faculty career development. The common goal is to gain fundamental new insights that will result in significant improvement of the existing “standard of care” and meet the challenges of dwindling extramural support.

OBJECTIVES/SPECIFIC AIMS: Addressing Disparities in Asian Populations through Translation research (ADAPT) is a community-research partnership funded by the Tufts Clinical Translational Sciences Institute (CTSI). Founded in 2011, this collaborative brings together 7 Chinatown-serving community-based organizations and academic researchers with the goal of improving health for the local Chinatown community and beyond. The goal of this research project was to document the best practices, lessons learned, and process through which ADAPT has developed and grown. The aim of this project is to disseminate the model to other CTSAs who are currently engaged in METHODS/STUDY POPULATION: We used a combination of qualitative interviews and content analysis to gather data on the evolution of ADAPT over the last 5 years. Current members from both community organizations and the university/medical center were interviewed about their experiences participating in ADAPT. When possible, interviews were recorded and transcribed verbatim. Deidentified transcripts and administrative documents including meeting minutes, conference summaries, bylaws, and mission statements were coded using Dedoose analytic software. RESULTS/ANTICIPATED RESULTS: Established community-based participatory research (CBPR) principles, including mutual respect, transparency, and commitment, are viewed as necessary, but not sufficient. Patience—both with other members and with the group as a work in progress—is highlighted as being a necessary characteristic of participants. Time and funding are 2 of the most important resources, and the majority of members agree that there is no substitute for “skin in the game.” Attempts at last minute, opportunistic engagement were provided as examples of what had not worked. One ongoing tension is the balance between process and product. Individual members are beholden to organizations to different degrees, and the need to produce something in the form of publications or grant money can limit the amount of time members can commit to the collaborative. At the same time, these products are unlikely to materialize if members are not invested in the process of growing and sustaining the collective. DISCUSSION/SIGNIFICANCE OF IMPACT: Out of the 7 community organizations who currently participate in ADAPT, only 1 is explicitly focused on health in the traditional sense. The others are primary service organizations, but because they understand the impact of the social determinants of health on the local community—including housing, employment, education, nutrition, among other factors—the research collaborative is able to leverage the knowledge and expertise of the academic researchers and the community partners to focus on health topics most salient to the local Chinatown community.

OBJECTIVES/SPECIFIC AIMS: The proposed pilot study seek to enhance the network of CTSAs at Rockefeller University, NYU, ISMMS, and other community members to support translational workforce development of clinical research nurses and establish a standardized nurse-specific training curriculum in GCP for use within the CTSA network, in other research centers, and in nursing school curricula. This will be coupled with a rigorous evaluation study to test the impact of the training and a comprehensive dissemination plan to make the training available to all nurses and nursing students via modern e-learning method. Aim 1. To create an integrated network of local CTSAs and community partners to develop, validate, and refine a pilot e-learning GCP educational and training program and content and outcomes dissemination plan. It is vital to integrate the efforts of CTSA leaders, community partners, and nursing educators to develop a pilot e-learning nurse workforce training curriculum and the associated evaluation measures and assessment plan. Delphi methods will be employed, coupled with rigorous assessment of face validity, content validity, and item reliability. The resulting educational training program will then be used for an e-learning educational intervention study in CTSAs, other sites, and nursing schools. Aim 2. To test the effect of the pilot GCP education and evaluation program for practicing clinical research nurses (CRNs) within the collaborating CTSAs and community partners, we will perform a randomized controlled trial using a Solomon 4 group design. For the student nurse population, we will develop a randomized control trial using a Solomon 4 group design blocked on course section. As this is a pilot study, descriptive statistics and confidence intervals around parameter estimates will be constructed. In addition, inferential statistics will be calculated on primary outcome of interest (change scores in knowledge of GCP) and measures of heterogeneity of data, patterns of missing data, and reliability of evaluative tools will be analyzed. Aim 3. To implement a dissemination plan to reach both nurses practicing the CRN specialty within CTSAs and other community settings. We will disseminate the program to other CTSAs through the CTSA network communication resources. To broaden the reach to a population of nurses and student nurses with limited prior education or training in nurse-specific GCP competencies, but who provide care to research participants in nontraditional research settings, we will craft a novel set of dissemination methods, including the CITI Program electronic platform that can be accessed by nurses and nursing students across settings. In addition, dissemination will be at nursing education meetings and in nursing journals.METHODS/STUDY POPULATION: There are several components to this pilot program. The component that includes a research strategy is the testing of the effectiveness of the training and educational interventions on GCP knowledge and efficacy. Study cohort: Recruitment of study subjects will be in coordination with 3 CTSA collaborators and community partners for 2 samples: (1) nurses who provide care to clinical research participants across a variety of settings (health care systems, research hospitals, and care provider networks) and who are already trained according to current standard in GCP, (2) nursing students from the collaborative network of the 3 CTSAs, NYU School of Nursing has agreed to pilot test the introductory student module. The methodological approach will be a random assignment control trial Solomon 4 group design for practicing CRNs within the collaborating CTSAs and community partners. For student nurse population, the methodological approach will be a randomized-control trial Solomon 4 group design blocked on course section. Survey measures of CRN GCP knowledge and efficacy will be obtained pre and post educational intervention. RESULTS/ANTICIPATED RESULTS: Aim 1. Expected outcomes are pilot e-learning nurse workforce training modules curriculum, and evaluation measures and plan appropriate for CTSAs, community sites, and nursing schools. Specifically, 14 modules (averaging 30 minutes each) for practicing CRNs, and one 45 minute module for nursing students. The significance of these findings will provide a framework for the e-learning educational intervention study. CITI Program is enthusiastic about the module development and refinement and will provide direction for consistency in formatting with current CITI Program modules, set-up of learner groups for comparison, and evaluative measures such as completion data and scoring. Aim 2. Expected outcomes are an effective pilot educational intervention for practicing nurses and students and valid and reliable evaluation tools and plan that can be generalized to the larger CRN and nursing community. Aim 3. Expected outcomes are an enhanced CTSA dissemination plan that includes non-CTSA resources and reaches non-CTSA employed nurses and nursing students. DISCUSSION/SIGNIFICANCE OF IMPACT: The expected outcomes of this pilot study are: (1) an enduring GCP education that can be continually updated and training structure for CRNs, and nurses and nursing students throughout the United States; (2) a reproducible effective standardized basic nurse-specific GCP curriculum for dissemination; (3) assessment tools to evaluate programmatic success, nurse and nursing student knowledge and efficacy on nurse-specific GCP; (4) and a CTSA dissemination plan that to reach non-CTSA nurses and nursing students. Our ultimate goal is the development of a translational workforce educated and competent in GCP at CTSA sites, at non-CTSA sites, and in nursing schools so as to improve the quality of clinical research.

OBJECTIVES/SPECIFIC AIMS: To increase knowledge and application of clinical research coordinator competencies among Research Professionals at the University of Minnesota. METHODS/STUDY POPULATION: The UMN’s CTSI developed and piloted a Foundations for Research Professionals training program comprised of: a baseline assessment, 7 online modules, 4 in-person training sessions, video and reading assignments and a post assessment, which totaled 30–35 hours of training and covered the following topics: preparing for a study, study management, participant recruitment and engagement, assessing capacity to consent and the informed consent process. This course also provides valuable resources and connections to online references and materials. The competencies for this program were based on work of the Joint Task Force for Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: 30 clinical research professionals completed the pilot program and averaged an increase of 6.5% from baseline assessment to post assessment. Participants were asked to rate their confidence on a variety of role-based competencies at the time of preassessments and postassessments. Trends show an increase in confidence for all competency areas after completion of the training program. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a workforce of competent research professionals is integral to improve the efficiency, quality, and ethics of research. The Foundations for Research Professionals training program increased knowledge of clinical research coordinator competencies. We will assess impact on application of the competencies 6 months after completion of the program. Our next steps include offering the training program as a 2-week session on an ongoing basis for new coordinators at the University of Minnesota.

OBJECTIVES/SPECIFIC AIMS: Existing GCP training is geared primarily towards researchers conducting drug, device, or biologic clinical trials, and largely ignores the unique needs of researchers conducting social and behavioral clinical trials. The purpose of this project was to develop a comprehensive, relevant, interactive, and easy to administer GCP eLearning course for social and behavioral researchers. METHODS/STUDY POPULATION: As part of the ECRPTQ project funded by the National Center for Advancing Translational Sciences (NCATS), a Social and Behavioral Work Group of ~30 experienced social and behavioral investigators and study coordinators was formed to develop GCP training for social and behavioral researchers. Existing GCP training programs were reviewed to identify relevant content that should be included as well as gaps specific to social and behavioral clinical trials where new content would need to be developed. In total, 9 specific modules—Introduction, Research Protocol, Roles and Responsibilities, Informed Consent Communication, Confidentiality/Privacy, Recruitment/Retention, Participant Safety/Adverse Event Reporting, Quality Control/Assurance, and Research Misconduct—were identified by the work group and the content was mapped to competency domains defined by the ECRPTQ project, as well as International Council for Harmonisation (ICH) GCP principles. Several investigators and study coordinators were identified as content experts for each module topic. Working with an instructional designer, these experts defined learning objectives and outlined content relevant for both study coordinators and investigators for inclusion in the modules. The curriculum was developed using Articulate Storyline that is SCORM 1.2 compliant making the course usable to the widest audience. The course was designed to be administered on laptop or desktop computers and is accessible for individuals with hearing or viewing impairments. To maximize learning, instructional designers used creative treatments including: narration to guide learners or offer tips; short video scenarios to introduce topics; interactive activities, such as drag and drop games and “click to learn more information”; knowledge checks with feedback; resources, including downloadable job aids; end of module quizzes, and documentation of course completion. The full curriculum takes 2–4 hours to complete, with individual modules taking 30 minutes to complete. RESULTS/ANTICIPATED RESULTS: Pilot testing to evaluate the effectiveness of the eLearning course is underway at 5 sites: University of Michigan, Boston University, University of Rochester, University of Florida, and SUNY Buffalo. DISCUSSION/SIGNIFICANCE OF IMPACT: This eLearning course provides relevant, comprehensive GCP training specifically for social and behavioral researchers. Unlike existing GCP training that is geared towards drug and device researchers, this course includes scenarios and examples that are relevant to social and behavioral researchers. The engaging, interactive nature of this course is designed to improve learning and retention, resulting in improved job performance. In addition, the modules are designed for both investigators and clinical research coordinators, thus eliminating the need for different training modules for different study team members.

OBJECTIVES/SPECIFIC AIMS: Our objectives are to provide opportunities for graduate students, clinical interns, and postdoctoral fellows in traditional training programs to have immersive experiences in clinical research conduct from a CRP perspective. In addition, we aimed to address common causes of job dissatisfaction by providing professional development and networking opportunities for the existing CRP workforce. METHODS/STUDY POPULATION: In collaboration with the CTSA workforce development group, the Duke Office of Clinical Research hosted a site visit for 19 PhD scientists interested in nontraditional career pathways and a short lecture series on project management careers in clinical research. Additionally, we crafted specific clinical research training electives for 20 masters students and 10 dietetic interns. Finally, in collaboration with UNC-CH, we combined Research Professional Networks to provide a pilot joint professional development event for 109 CRPs from both schools. RESULTS/ANTICIPATED RESULTS: The number of Masters students enrolling in the CRP elective grew from 7 students in year 1 to 13 students currently enrolled. A retro-pre/postprogram adapted CRAI survey was issued following program completion. Students self-reported increases in competence across all 24 skills measured. Largest increases were seen in areas specific to CRP roles such as consenting patients, understanding the IRB, and reviewing key study documents. A baseline culture survey issued at the joint Duke/UNC CRP event garnered a 65% response rate and indicated that the principal gaps in professional training are in communications, teamwork, leadership, and professionalism. Moreover, respondents indicated that creating a sense of community and providing networking opportunities were the most important outcomes for future CRP collaborations. Future evaluations of both of these programs will allow us to tailor training to be most effective in strengthening our CRP workforce. DISCUSSION/SIGNIFICANCE OF IMPACT: These initiatives lay the groundwork for the development of a robust training pipeline into CRP careers. Future initiative will apply lessons learned toward creating internship programs aimed at improving diversity and inclusion within these careers. In addition, by addressing the professional development needs of the existing workforce, we create a sustainable environment for well-trained professionals. By evaluating these primary initiatives, we can better define the critical elements that must be included in CRP educational, development, and support programs and subsequently apply these to ultimately improve the clinical and translational research being conducted in academic research settings.

OBJECTIVES/SPECIFIC AIMS: Enhancing Patient Safety for hospitalized patients is a priority for healthcare facilities, providers, and federal funding agencies. Multidisciplinary partnerships in clinical and translational research better defines the scope of complex patient-safety issues, and is part of more effectively developing interventions. The discipline represented by engineering-trained partners brings valuable perspective to patient safety problems through their training background in human factors and systems analysis. The objective of this education program was to create and implement a collaboration between engineering students and clinical providers. Through the Johns Hopkins Institute for Clinical and Translational Research, a multidisciplinary partnership was created, to identify contributing factors, and suggest novel solutions, to key patient safety problems using an ethnographic research approach. METHODS/STUDY POPULATION: The collaboration was formed between the following Johns Hopkins (JH) groups: (1) The Institute for Clinical and Translational Research (ICTR), (2) The Armstrong Institute for Patient Safety, (3) The JH Hospital Clinical Engineering Services, (4) The Homecare Group, (5) The Masters of Science in Engineering Management Program at the Whiting School of Engineering, and (6) The JH Hospital Risk Management. All 6 provided representation to contribute to the planning, structure, and implementation of the project. The initial cohort was 24 masters students enrolled in the JHU Whiting School of engineering, and included 46% men, 54% women, and 75% international students. Students were placed in teams of 2–3 to work on 9 distinct patient safety concerns, as provided by the Armstrong Institute as priority. Potential clinical hosts from the appropriate clinical departments were vetted for feasibility and scope before students were assigned to them. Students and clinical hosts were oriented to the process. The students then spent 3–6 hours a week, for 7 weeks, observing and interacting with patients and health professionals at their specific clinical sites, conducting ethnographic research under the guidance of their hosts. Ethnographic research is the systematic investigation of a culture or system; in our application, teams were looking at the environment, culture, and its contributing factors, with respect to patient safety issues. Teams made observations, then formulated hypothesis and collected data relevant to what systems factors may be contributing to the patient safety issue. Following data collection and analyses, teams made recommendations for culture and/or systems shifts that could impact change and improve patient safety. Ethnography research process training is a tenet of the training undertaken by all Masters of Science in Engineering Management Students. RESULTS/ANTICIPATED RESULTS: At the end of the 7-week project, each team generated a comprehensive report suggesting potential solutions for each problem, and gave presentations on their findings to their peers, clinical hosts, and JHU steering committee representatives. Requirements on the student side included a midterm, final presentation, and report. Both students and site leaders submitted mid- and final program evaluations. Based on follow-up survey data, 71% of students said that the course may impact their career choice, 57% said the collaboration changed the way they viewed themselves, and 28% elected to continue working or were planning to work with their site in some fashion after the course ended. Nearly 60% of students believed additional funding or resources would benefit the course and 71% thought they would benefit from more or similar experiences with their clinical partners. Furthermore, 85% wanted to see the course expanded. Of the clinical hosts, 71% said that students added value, 86% believed students changed their perspective on their problem, unveiled new areas of investigation, and improved or likely would improve patient safety in their department. Seventy-one percent of hosts were actively acting on the students’ findings, and over 86% shared findings with their colleagues. Following the 7-week program, 2 teams also presented their findings to committees within the hospital departments, 2 patient-safety projects are being continued with engineering teams, and 2 new collaborative projects have been initiated. Based on the popularity of this program with the students, hosts, and teaching faculty, this will be implemented within the engineering curriculum for a second time next year. Additional outcomes data collection are currently ongoing, and we plan to continue to monitor and analyze results. DISCUSSION/SIGNIFICANCE OF IMPACT: In its first year our engineering collaboration exceeded expectations. Engineering students and clinical providers successfully worked toward tangible solutions that were directly applicable to patient care. Furthermore, interactions were both personally and professionally beneficial for students while simultaneously adding value to clinical hosts. Beyond the collaboration, this initiative allowed for secondary connections between engineers and clinicians that are also have great potential for resulting in translational innovation. Despite the overwhelming success of this project, it highlighted the need for increased resources for sustainability. Our pilot highlighted a role for funding with regards to: (1) students in the execution of their projects (eg, transportation to sites, prototype materials); (2) clinical hosts, particularly protecting time to interact with and lead student teams; (3) the Armstrong Institute—to aid the identification and prioritization of high impact, patient safety projects; and (4) the ICTR for staff to facilitate placements, student orientation to the hospital setting, and program execution and maintenance. Ultimately, this collaboration addressed an unmet need for the clinical providers as well as the engineering students: thus, all partners agree that (1) the impact of this pilot would be greatly magnified by more time, longer duration, and additional resources; and (2) this collaboration could provide a useful model for approaching other complex health care problems. In terms of larger and longer-term impact, engaging engineers at the training level together with clinicians provides early exposure, and could potentially prime them to continue collaborations with clinical and translational science, across their careers.

Student Research Assistant Acknowledgements: The authors thank Manik Arora, Alexandra Morani, and Thomas Cornish -- Johns Hopkins University.

OBJECTIVES/SPECIFIC AIMS: To diversify the workforce by providing leadership and career coaching training to mentors so that they can be better leaders with their trainees and incorporate career coaching skills into their mentoring style. METHODS/STUDY POPULATION: PROMISED Program helps current and future members of the National Research Mentoring Network (NRMN) develop management, leadership, and career coaching skills so that they may be more effective in guiding their mentees. Studies show that mentees remain engaged in research when they drive their own careers, but mentors rarely help them recognize ways to do this. PROMISED aims to address by providing online leadership training and career coaching training. We developed innovative online leadership training for mentors committed to mentoring people from diverse backgrounds that are focused on management and leadership skills. These modules contain exercises, self-assessments, and discussion boards. We also have reading materials and other supplemental work such as videos to augment the modules. We also created 2-day training on career coaching skills for mentors. Certified career coaches trained participants in career coaching tools so that they could incorporate these skills into their mentoring style. Mentors tend to view themselves as content advisors, and they focus on the next step in the research project rather than the research career. We trained mentors to provide career coaching to their mentees, which will help the mentee establish a successful biomedical research career trajectory. RESULTS/ANTICIPATED RESULTS: In total, 45 mentors attended the Career Coaching Workshop. We assessed 26 mentoring/career coaching traits. Every trait improved on post survey (Likert scale 1–7), for example, “Taking into account the biases and prejudices you bring to the mentor/mentee relationship” (Pre: 4.16, Post: 5.38) and Working with mentees to set clear expectations of the mentoring relationship (Pre: 4.27, Post: 5.32). Some comments from attendees included: “amazing,” “powerful,” “excellent program,” “learned so much.” For the online module, we have a maximum of 20 fellows enrolled in each module. Results show that the fellows rate the module extremely useful. A comment from 1 fellow confirms this: “This session has changed my life and I know that the PROMISED program will transform my abilities as a mentor and as a person.” DISCUSSION/SIGNIFICANCE OF IMPACT: Providing Career Coaching Training and Online leadership skills can significantly improve mentors ability to mentor people, particularly those from diverse backgrounds. In addition, this training can help mentors who are committed to mentoring people from diverse backgrounds promote their own careers as well as their mentees.

OBJECTIVES/SPECIFIC AIMS: Goal—broaden the academic offer to enhance clinical and translational research productivity and cost effectiveness. Objective—implement a distance learning program on conducting proficient research management. METHODS/STUDY POPULATION: Needs assessment attested students’ interest in enrolling and willingness to recruit graduates by the research industry and academia. A master of science in clinical research management and regulatory compliance (MS-CRMRC) was developed using the Core Competency Domains for Clinical Research Professional. Experts from research academia, pharmaceutical industry, composed a Proposal Development Committee. RESULTS/ANTICIPATED RESULTS: Access of a distance learning MS-CRMRC program for students with time constrains. Competent research professional graduates working side by side with the principal investigator on onsite teamwork management, to streamline research processes in compliance to regulations. DISCUSSION/SIGNIFICANCE OF IMPACT: Improvement of clinical and translational research productivity and efficient use of grants funds prevails as a generalized concern. The MS-CRMRC offers an accessible alternative to empower the research enterprise by developing knowledgeable skilled professionals to tackle this need.