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/GOALS: Racial/ethnic minoritized children experience poorer cancer outcomes, which may be driven by structural racism. We apply an index that combines segregation and neighborhood vulnerability to a pediatric oncology population and assesses its association with acuity of illness at initial presentation. METHODS/STUDY POPULATION: A retrospective analysis will be performed in a cohort of pediatric patients diagnosed with solid tumors at Children’s Healthcare of Atlanta (CHOA) from 2010-2018 (N=1149). The sample will be linked to a structural racism index (SRI) that has been established in our prior work. We abstract data from medical records to quantify initial acuity of illness based on the need for ICU-level resources. Differences in sociodemographic characteristics will be analyzed by the SRI, using chi-squared, Student t-tests, and ANOVA where appropriate. Logistic regression models will be used to assess the association of the SRI with acuity of illness. RESULTS/ANTICIPATED RESULTS: We anticipate that relevant sociodemographic characteristics (e.g., race/ethnicity, insurance status) differ by the SRI. The CHOA Cancer Registry includes a racially and ethnically diverse group of patients: 63% of the cohort is White, 30% is Black,10% are Other, and 15% are Hispanic/Latino. Furthermore, we anticipate that pediatric patients with solid tumors living in counties with greater levels of structural racism as measured by the SRI experience an increased acuity of illness at initial presentation. DISCUSSION/SIGNIFICANCE: By applying a novel index quantifying structural racism, we will provide new information about the structural barriers patients and families face prior to a pediatric cancer diagnosis. This work will allow us to identify areas for potential interventions in this vulnerable young patient population.

OBJECTIVES/GOALS: A qualitative study was performed to characterize experiences of Black and White women going through menopause, as well as identify barriers and facilitators for participating in a lifestyle program targeting weight management during menopause. This abstract includes data from Black women. Results from White women will be available by ACTS 2022. METHODS/STUDY POPULATION: Perimenopausal and postmenopausal Black women with a self-reported desire to lose or maintain weight during menopause participated in a total of six focus groups. Women were asked about their past experiences with diet, exercise, and weight management; their menopause experiences; as well as specific components and considerations for developing a lifestyle program for weight management. Thematic analysis was conducted on coded transcripts and four main themes emerged, each containing three to seven subthemes. RESULTS/ANTICIPATED RESULTS: Twenty-seven Black women (age 54±4 years, BMI 35.1±9.0 kg/m2) were enrolled. Overall, women felt unprepared for the changes they experienced during menopause and had difficulty maintaining or losing weight. While women were receptive to trying different diets and exercises, they wanted a diet that was flexible with their lifestyle and exercises that considered their existing health status. Women were also interested in learning about menopause alongside other women, stating that medical professionals did not provide them with adequate information or help. Social support, accountability, and seeing results were perceived critical to achieve long-lasting behavioral change. DISCUSSION/SIGNIFICANCE: Women were interested in receiving menopause information and improving their overall health as part of a lifestyle program during menopause. Associating with other women affected by menopause will allow for the creation of more sustainable lifestyle programs during menopause.

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/GOALS: The United States is experiencing an epidemic of firearm deaths and injuries. Poverty and other socioeconomic factors have been linked to firearm injuries on the national level. The goal of this study is to examine the relationship between county level poverty and firearm injuries in the State of Maryland. METHODS/STUDY POPULATION: This is a cross sectional study assessing fatal and non-fatal firearm injuries of all ages between 2018-2020 utilizing data from the State of Maryland’s Health Services Cost Review Commission. Our primary analysis will involve calculating injury and mortality rates to assess if fatal and non-fatal firearm injuries are associated with county-level poverty, defined as the percentage of the population living below the federal poverty line. Rates will be calculated by determining county level population within subgroups using the National Historical Geographical Information System database. We will also conduct regression analyses to adjust for confounding variables selected based on evidence from prior research. Some of these variables include age, sex, race, urbanicity, and the social vulnerability index. RESULTS/ANTICIPATED RESULTS: An abundance of prior research has demonstrated differences in firearm injury by age, sex, and race. Prior studies have also shown that poverty is associated with higher rates of firearm-related deaths among youth. Based on that foundational data, we anticipate that regression analyses will demonstrate that counties with higher poverty levels will have higher rates of fatal and non-fatal firearm injuries, even after controlling for other known risk factors. DISCUSSION/SIGNIFICANCE: Findings from this study will contribute to growing evidence on the role of poverty in the burden of firearm injuries and mortality. This will have policy implications regarding the allocation of public health resources and interventions aimed at reducing firearm-related injuries and deaths in Maryland.

OBJECTIVES/SPECIFIC AIMS: This study aims to assess the safety, feasibility, clinical benefits and pharmacodynamics of adding allopurinol to standard maintenance therapy that includes 6-mecaptopurine (6-MP) in pediatric patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. Our goal is to investigate if allopurinol improves hepatotoxicity and GI toxicity, if it safely decreases acute neutrophil count (ANC), if it reduces the 6-MP dose required during chemotherapy, and if it works through our hypothesized mechanism by lowering the levels of the toxic metabolite, 6-methylmecaptopurine (6-MMP) and by raising the levels of the active metabolite, 6-thioguanine (6-TGN). METHODS/STUDY POPULATION: This is a single arm, nonblinded pilot study of patients under age 30 years who were being treated in the maintenance phase of therapy for ALL or lymphoblastic lymphoma, and had adverse effects such as high 6-MMP:6-TGN ratio, high ANC, and high liver enzymes. Patients enrolled were started with allopurinol in addition to ongoing oral chemotherapy. Data from beginning maintenance to end of chemotherapy was collected in the electronic medical record, EPIC for the 13 patients enrolled at Johns Hopkins, and data analysis was conducted using STATA and Excel. RESULTS/ANTICIPATED RESULTS: Initial data analysis reveals that the required dose of 6-MP after addition of allopurinol to the chemotherapy regimen was significantly lower compared with that before the addition of allopurinol in 11 out of the 12 patients assessed (p<0.05). Among the 10 patients that were assessed for 6MMP:6TG ratio, all had lower average 6MMP:6TGN ratios after allopurinol compared to before allopurinol; the percentage of weeks that goal 6MMP:6TGN ratio (<40) were maintained were statistically significant in 6 patients (p<0.05) and close to significance in 2 other patients (p=0.057). The percentage of weeks that patients maintained alanine aminotransferase levels below 120 was significantly greater after addition of allopurinol compared to before the addition of allopurinol in 9 out of 13 patients assessed, suggesting that allopurinol may be associated with reduced hepatotoxicity. Further data analysis is ongoing to assess the percentage of weeks that patients maintained goal total bilirubin, direct bilirubin, and ANC, as well as average number of admissions for infections and average number of therapy holds after allopurinol addition compared to before allopurinol addition. DISCUSSION/SIGNIFICANCE OF IMPACT: Allopurinol is associated with reduction in required 6-MP dose, decrease in the percentage of weeks that patients have hepatotoxicity, and reduction in the ratio of toxic metabolite to active anti-leukemic metabolite in several patients. We hope that the results of this study can be used for further research and for guiding clinical practice since there are no established guidelines in pediatric oncology regarding addressing side effects of oral chemotherapy using 6-MP. If allopurinol indeed is safe and effective, adding it to the standard chemotherapy regimen can lead to better tolerance and compliance to oral maintenance chemotherapy, and hopefully improved outcomes for children with ALL and lymphoblastic leukemia.

OBJECTIVES/GOALS: To evaluate the feasibility, acceptability, and appropriateness of a 1:1 peer-delivered psychosocial support intervention to family caregivers of hospice patients with cancer, and determine a range of potential effects of the intervention on psychological distress symptoms and perceptions of the caregiving experience. METHODS/STUDY POPULATION: Quantitative and qualitative data were collected from hospice caregivers of cancer patients who participated in a non-controlled pilot feasibility trial of a 1:1, peer-delivered psychosocial intervention called Peer Caregiver Navigation (PCN). The purpose of this study was to evaluate the feasibility, acceptability, and appropriateness of delivering PCN to hospice family caregivers of cancer patients, and to determine a range of potential effects of PCN on caregivers’ anxiety symptoms, depressive symptoms, self-efficacy, and benefit finding. Qualitative data were analyzed using deductive thematic analysis. For our study outcomes, we used both parametric and nonparametric t-tests to examine mean differences between outcomes at baseline and midpoint, and baseline and endpoint. RESULTS/ANTICIPATED RESULTS: The findings demonstrate that Peer Caregiver Navigation (PCN) is acceptable, appropriate, and feasible to deliver to hospice family caregivers of cancer patients. Appropriateness of our selected target outcomes was determined by confirming expected measurement change in depressive symptoms (lower), anxiety symptoms (lower), benefit finding (higher), and self-efficacy (higher). Exit interviews revealed that participants responded favorably to our selected measures for these outcomes and to our data collection time intervals. Moreover, recruitment and consenting processes, survey completion rates, and attrition outcomes (i.e., study exit due to active withdrawal vs. patient death) were analyzed to inform recruitment and retention feasibility for future studies. DISCUSSION/SIGNIFICANCE: Peer Caregiver Navigation (PCN) was determined to be feasible, acceptable, and appropriate to hospice family caregivers of patients with cancer. Moreover, PCN has the potential to improve caregivers' symptoms of psychological distress by providing them much needed psychoeducation, coping skills training, and emotional support.

Objectives/Goals: The Competency-Based All-Level Training (COBALT) curriculum standardizes learning for clinical research coordinators (CRCs) across multiple institutions within Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI), with flexible, topic-specific training at all experience levels, in both academic and industry-sponsored research. Methods/Study Population: The COBALT curriculum was developed in collaboration with subject matter experts, managers of CRCs, and other clinical research professionals from institutions across the WWAMI region. A thorough assessment of existing training programs within the region helped identify gaps and unmet needs. The curriculum was designed within a user-friendly learning management system that can be accessed across institutions. It has been piloted with diverse groups and committees of CRCs, professionals, and institutional leaders in clinical and translational science. Ongoing evaluation is being conducted qualitatively using built-in assessment surveys, demonstrations, and interviews. Results/Anticipated Results: The anticipated outcome is the creation of a highly standardized and efficient training program for clinical research professionals across multiple institutions in the WWAMI region. This program will be carefully tailored to each professional’s level of experience, ensuring personalized skill development. By aligning training with diverse expertise levels, the initiative aims to significantly elevate the quality, consistency, and overall performance of clinical research efforts across the regional research community. Discussion/Significance of Impact: The COBALT curriculum provides a vetted learning curriculum for CRCs, with a tailorable training plan that helps them collaborate with their supervisors to tailor training to their career goals. This ensures that the curriculum is not only comprehensive but also adaptable to individual needs.

OBJECTIVES/GOALS: Harnessing the EHR to support clinical research is critical for the study of rare diseases such as interstitial lung disease (ILD). However no studies have compared EHR and research-quality data in the ILD population. Our objectives were to (1) identify ILD patients and extract clinical data from an EHR system and (2) assess the performance of ILD data capture. METHODS/STUDY POPULATION: Case validated algorithms were implemented to identify patients from the University of California San Francisco EHR and extract key ILD clinical information including, demographic variables, process measures and patient outcomes. Key clinical information were defined based on consensus statements and ILD clinical trials. A subset of ILD patients, had variables recorded in both the EHR and a separate ILD longitudinal research database. The completeness of EHR data capture and level of agreement were compared between three data collection methods: (1) data manually and systematically collected for an ILD research database (gold standard), (2) data automatically extracted from structured fields in the EHR, and (3) data extracted from unstructured data sources. RESULTS/ANTICIPATED RESULTS: We identified 5857 ILD patients in the EHR, of which 2100 patients had data available in the both the EHR and research database. Baseline demographic variables, co-morbidities, use of diagnostic testing, pharmacotherapy were accurately extracted from structured fields. Outcome measures, including lung physiology, radiographic patterns, pathology results, and health related quality of life (HRQoL) were unevenly extracted from structured fields alone. With the exception of HRQoL, these measures were accurately captured in unstructured EHR sources. Notably, certain metrics were better defined in the EHR, including health care resource utilization metrics, acute exacerbations, medication side effects, supplemental oxygen use and specialty care referrals (rheumatology, lung transplant, palliative care, etc). DISCUSSION/SIGNIFICANCE OF IMPACT: A large real-world ILD cohort can be algorithmically extracted from the EHR along with key clinical variables with accuracy comparable to protocol-driven research databases. Rigorous assessment of the types of disease-specific variables that are present in EHR-derived data will inform future interventions to improve the fidelity, accessibility and use of the EHR in clinical research.

OBJECTIVES/SPECIFIC AIMS: To evaluate the ability of various techniques to track changes in body fluid volumes before and after a rapid infusion of saline. METHODS/STUDY POPULATION: Eight healthy participants (5M; 3F) completed baseline measurements of 1) total body water using ethanol dilution and bioelectrical impedance analysis (BIA) and 2) blood volume, plasma volume and red blood cell (RBC) volume using carbon monoxide rebreathe technique and I-131 albumin dilution. Subsequently, 30mL saline/kg body weight was administered intravenously over 20 minutes after which BIA and ethanol dilution were repeated. RESULTS/ANTICIPATED RESULTS: On average, 2.29±0.35 L saline was infused with an average increase in net fluid input-output (I/O) of 1.56±0.29 L. BIA underestimated measured I/O by −3.4±7.9%, while ethanol dilution did not demonstrate a measurable change in total body water. Carbon monoxide rebreathe differed from I-131 albumin dilution measurements of blood, plasma and RBC volumes by +0.6±2.8%, −5.4±3.6%, and +11.0±4.7%, respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: BIA is capable of tracking modest changes in total body water. Carbon monoxide rebreathe appears to be a viable alternative for the I-131 albumin dilution technique to determine blood volume. Together, these two techniques may be useful in monitoring fluid status in patients with impaired fluid regulation.

Objectives/Goals: The number of FDA-approved cellular and gene therapy products has doubled from 23 in 2022 to 46 in 2025. For allogeneic cell therapies, cell banks are essential both during preclinical development and manufacturing clinical products. The objective of this study is to establish a cell bank system for preclinical research of a cartilage repair biologic. Methods/Study Population: To conduct large animal preclinical studies required by the FDA for load-bearing cartilage repair products, the FDA has described in its guidance documents for Investigational New Drug (IND) applications the use of an animal-based “analogous cellular product” (ACP). Here, costal chondrocytes from 6 minipigs (3 male, 3 female) were isolated and expanded to create master cell banks (MCBs) at passage 2. ACPs (i.e., tissue-engineered neocartilage) were generated from each MCB, and the critical quality attributes, properties such as morphology and mechanics, were assessed. By comparing functional properties of the ACPs to those of the native cartilage tissue they intend to replace, donors were selected for inclusion in working cell banks (WCBs) to support both academic research and ongoing IND-enabling research. Results/Anticipated Results: All six donors produced tissue-engineered cartilage that passed morphologic release criteria (i.e., round, flat). However, ACPs showed distinct donor-based variability in terms of mechanical release criteria (e.g., tensile Young’s modulus and compressive aggregate modulus). Based on release criteria data, two types of WCBs were created at passage 5: 1) a pooled donor WCB for academic studies that require multiple donors and 2) multiple single-donor WCBs for manufacturing ACPs tested in ongoing IND-enabling dose-response and pivotal long-term studies. It is estimated that between 160k-400k, ACP constructs can be produced from each of the six MCBs, analogous to clinical-scale manufacturing. Discussion/Significance of Impact: Overall, this study illustrates a cell bank system that can be used to support IND-enabling research. This cell bank produced preclinical neocartilage analogous to the intended clinical product, and it is currently being used in dose-response and pivotal long-term large animal studies for temporomandibular joint disc repair.

ABSTRACT IMPACT: This review will encourage further development of novel uses of REDCap for the benefit of the research community. OBJECTIVES/GOALS: REDCap is a clinical research data collection platform that is primarily used as intended. However, little is known about its more novel uses, specifically in clinical decision support in patient care and in clinical research management. Thus, the purpose of this review is to examine peer reviewed literature identifying and describing such novel uses. METHODS/STUDY POPULATION: A systematic search was conducted in both PubMed and Google Scholar using the equation ((REDCap) OR ('Research Electronic Data Capture')) AND ((Clinical Trial Management) OR (Clinical Research)).’ Articles were screened by title, then abstract, and then were reviewed in full if they met inclusion criteria. Articles were included if they had potential relevance to the topic of REDCap or if they mentioned activities related to fields of clinical and translational science including operational support in areas such as clinical research management. Articles were excluded if they focused on common clinical research activities relating to data collection software such as survey administration, database building or data collection for clinical trials, registries, and cohort studies. RESULTS/ANTICIPATED RESULTS: The initial search yielded 390 results, of which 40 underwent an abstract review; only 8 of these underwent full text review. Of these, 5 discussed uses of REDCap in the context of operational support in clinical research management; 3 were related to clinical decision support in patient care. For the 5 articles focused on operational support in clinical research management, topics include e-consenting procedures, collection and storage of protected health information (PHI), patient recruitment and tracking stakeholder engagement. The 3 articles about clinical decision support discuss REDCap tools for generating risk predictions for post-surgical clinical outcomes, generating recommendations and STI test orders, and increasing efficiency in hand-offs to enhance care of surgical oncology patients. DISCUSSION/SIGNIFICANCE OF FINDINGS: Considering that only a small percentage of peer reviewed research reports out on novel uses of REDCap, there is a need for the REDCap consortium to do further work to fulfill its mission to adopt, innovate, and suggest novel uses of REDCap, thus expanding the understanding of its functionalities and therefore its utility in the research community.

OBJECTIVES/GOALS: Identify the interactions between nasopharyngeal bacterial pathogens, commensals, and patient clinical characteristics in relation to the development of viral upper respiratory tract infections (URI) and acute otitis media (AOM) in infants. METHODS/STUDY POPULATION: The subjects were part of a prospective, longitudinal study (2008–2014) of infants to evaluate the prevalence and risks for the development of URI and AOM. Healthy infants (n = 362) were enrolled from near birth and followed to the first episode of AOM up to 12 months of age. Nasopharyngeal specimens and clinical traits were collected at monthly intervals between 1-6 months, month 9, and during viral URI episodes. Subjects were closely followed for AOM development. 16S rRNA sequencing was performed on the nasopharyngeal swabs to identify their bacterial composition. Multidimensional (2, 3, and 4 dimensional) co-presence, co-exclusion, and one-way relation patterns were identified between the microbiome compositions, health status, and other collected clinical traits. RESULTS/ANTICIPATED RESULTS: We analyzed 971 specimens collected monthly and during URI and AOM episodes from 139 infants. Of the 139 enrolled subjects, 96% had 2 or more healthy samples, 77% contracted URI/AOM during the study period, and 60% had at least 1 healthy sample before URI/AOM onset. Otopathogens (Moraxella, Haemophilus, and Streptococcus), Staphylococcus, and Pseudomonas were the most common pathogenic genera. Corynebacterium, Dolosigranulum, and Acinetobacter were 3 most abundant commensal bacterial genera. Samples from infants with AOM in the first year had a significantly higher relative abundance of Haemophilus, Enterobacter, and Yersinia, and lower relative abundance of Corynebacterium, and Pseudomonas compared to samples from infants who did not develop AOM. DISCUSSION/SIGNIFICANCE OF IMPACT: Identification of complex multidimensional interaction patterns within microbial communities and environmental factors is vital to understanding disease onset risk and prevention. Prophylactic microbiome and environmental factor modulation between enterotypes could be used to reduce URI/AOM onset in infants.