There is a growing trend for studies run by academic and nonprofit organizations to have regulatory submission requirements. As a result, there is greater reliance on REDCap, an electronic data capture (EDC) widely used by researchers in these organizations. This paper discusses the development and implementation of the Rapid Validation Process (RVP) developed by the REDCap Consortium, aimed at enhancing regulatory compliance and operational efficiency in response to the dynamic demands of modern clinical research. The RVP introduces a structured validation approach that categorizes REDCap functionalities, develops targeted validation tests, and applies structured and standardized testing syntax. This approach ensures that REDCap can meet regulatory standards while maintaining flexibility to adapt to new challenges. Results from the application of the RVP on recent successive REDCap software version releases illustrate significant improvements in testing efficiency and process optimization, demonstrating the project’s success in setting new benchmarks for EDC system validation. The project’s community-driven responsibility model fosters collaboration and knowledge sharing and enhances the overall resilience and adaptability of REDCap. As REDCap continues to evolve based on feedback from clinical trialists, the RVP ensures that REDCap remains a reliable and compliant tool, ready to meet regulatory and future operational challenges.

Involving participants in the design of clinical trials should improve the overall success of a study. For this to occur, streamlined mechanisms are needed to connect the populations potentially impacted by a given study or health topic with research teams in order to inform trial design in a meaningful and timely manner. To address this need, we developed an innovative mechanism called the “ResearchMatch Expert Advice Tool” that quickly obtains volunteer perspectives from populations with specific health conditions or lived experiences using the national recruitment registry, ResearchMatch. This tool does not ask volunteers to participate in the trial but allows for wider community feedback to be gathered and translated into actionable recommendations used to inform the study’s design. We describe early use cases that shaped the current Expert Advice Tool workflow, how results from this tool were incorporated and implemented by studies, and feedback from volunteers and study teams regarding the tool’s usefulness. Additionally, we present a set of lessons learned during the development of the Expert Advice Tool that can be used by other recruitment registries seeking to obtain volunteer feedback on study design and operations.

The Dorchester Aqueduct, located to the north-west of Dorchester (Durnovaria) in Dorset, is arguably the most famous and well-examined Roman watercourse in Britain. The aqueduct has been intermittently investigated over the course of the last 100 years, but most extensively during the 1990s. The upper stretches of the aqueduct and its source have, however, eluded archaeologists, with multiple routes and water sources being suggested. A new programme of geophysical and topographic survey, combined with targeted investigation together with a reappraisal of the excavations from the 1990s, has provided additional evidence for the route of the aqueduct, extending its course for a further two kilometres to Notton on the River Frome.

Bio-Futures for Transplanetary Habitats (BFfTH) is a Special Interest Group within the Hub for Biotechnology in the Built Environment that aims to explore and enable interdisciplinary research on transplanetary habitats and habitats within extreme environments through an emphasis on the biosocial and biotechnological relations. BFfTH organized the online and onsite networking symposium BFfTH to examine how emerging biotechnologies, living materials, and more-than-human life can be implemented in habitat design and mission planning. The two-day symposium aimed to serve as a catalyst in establishing an international network and to support the development of novel methodologies to move beyond discipline-specific approaches. The symposium consisted of five sessions, including Mycelium for Mars and Novel Biotechnologies for Space Habitats. This opinion paper presents key outcomes and trends from these sessions, a moderated panel, and informal discussions. The identified research trends explored the use of biotechnology and biodesign to enhance safety, sustainability, habitability, reliability, crew efficiency, productivity, and comfort in extreme environments on Earth and off-world. Beyond design and engineering, the symposium also examined sociotechnical imaginaries, focusing on desired experiences and characteristics of life and technology in transplanetary futures. Some of the specific topics included innovative material-driven processes for transplanetary habitat design, socio-political and ethical implications, and technology transfer for sustainable living on Earth. The outcomes emphasize the necessity for advancing biosocial and biotechnological research from an interdisciplinary perspective in order to ethically and meaningfully enable transplanetary futures. Such a focus not only addresses future off-world challenges but also contributes to immediate ecological and architectural innovations, promoting a symbiotic relationship between space exploration and sustainability on Earth.

Background: Nursing home (NH) residents are at high risk of COVID-19 from exposure to infected staff and other residents. Understanding SARS-CoV-2 viral RNA kinetics in residents and staff can guide testing, isolation, and return to work recommendations. We sought to determine the duration of antigen test and polymerase chain reaction (PCR) positivity in a cohort of NH residents and staff. Methods: We prospectively collected data on SARS-CoV-2 viral kinetics from April 2023 through November 2023. Staff and residents could enroll prospectively or upon a positive test (identified through routine clinical testing, screening, or outbreak response testing). Participating facilities performed routine clinical testing; asymptomatic testing of contacts was performed within 48 hours if an outbreak or known exposure occurred and upon (re-) admission. Enrolled participants who tested positive for SARS-CoV-2 were re-tested daily for 14 days with both nasal antigen and nasal PCR tests. All PCR tests were run by a central lab with the same assay. We conducted a Kaplan-Meier survival analysis on time to first negative test restricted to participants who initially tested positive (day zero) and had at least one test ≥10 days after initially testing positive with the same test type; a participant could contribute to both antigen and PCR survival curves. We compared survival curves for staff and residents using the log-rank test. Results: Twenty-four nursing homes in eight states participated; 587 participants (275 residents, 312 staff) enrolled in the evaluation, participants were only tested through routine clinical or outbreak response testing. Seventy-two participants tested positive for antigen; of these, 63 tested PCR-positive. Residents were antigen- and PCR-positive longer than staff (Figure 1), but this finding is only statistically significant (p=0.006) for duration of PCR positivity. Five days after the first positive test, 56% of 50 residents and 59% of 22 staff remained antigen-positive; 91% of 44 residents and 79% of 19 staff were PCR-positive. Ten days after the first positive test, 22% of 50 residents and 5% of 22 staff remained antigen-positive; 61% of 44 residents and 21% of 19 staff remained PCR-positive. Conclusions: Most NH residents and staff with SARS-CoV-2 remained antigen- or PCR-positive 5 days after the initial positive test; however, differences between staff and resident test positivity were noted at 10 days. These data can inform recommendations for testing, duration of NH resident isolation, and return to work guidance for staff. Additional viral culture data may strengthen these conclusions.

Disclosure: Stefan Gravenstein: Received consulting and speaker fees from most vaccine manufacturers (Sanofi, Seqirus, Moderna, Merck, Janssen, Pfizer, Novavax, GSK, and have or expect to receive grant funding from several (Sanofi, Seqirus, Moderna, Pfizer, GSK). Lona Mody: NIH, VA, CDC, Kahn Foundation; Honoraria: UpToDate; Contracted Research: Nano-Vibronix

OBJECTIVES/GOALS: Since 2017, we have used the Design Lab methodology to support investigators taking innovative approaches to clinical effectiveness trial design. To date we have held 12 Design Labs and this year we are creating a handbook that will support dissemination of this approach across the Clinical and Translational Science Award consortium. METHODS/STUDY POPULATION: The Clinical Trial Design Lab brings together a multi-stakeholder group to consider innovative and impactful clinical trial designs. An investigative team is selected from a competitive pool of applicants, after which expert-led consultations support the investigator team to think about evidence generation in the context of the full treatment development pathway. Teams map the stakeholders at each step of this pathway (e.g. clinicians, patients, researchers, funders, industry experts, policy experts, regulatory experts, payers) and consider innovative design solutions. These consultations prepare investigators for an event that involves all stakeholders in a structured and facilitated discussion about trial designs that generate the best evidence and increase potential for health impact. RESULTS/ANTICIPATED RESULTS: The result of our work will be a set of Design Lab principles, a handbook with templates that support stakeholder mapping and structured discussions, and educational resources to accompany the handbook. The work is supported by a literature review that characterizes the multi-component processes included in the Design Lab, situates them within the larger context of team science interventions, and lays groundwork for the development of process metrics and impact evaluation criteria to assess the Design Lab method. In this poster presentation, we will share our multi-component broadly engaged team science approach, provide a brief outline of the principles and educational resources, and include an early version of the evaluation criteria. DISCUSSION/SIGNIFICANCE: Broadly engaged team science supports innovative thinking about study design and is especially important in the development of clinical trials. We have grown the Design Lab program of work over the past seven years and are now able to characterize our team science methodology and support others to use this approach to innovate for health impact.

OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a 6-CTSA Rockefeller-led collaboration to developcustom REDCap infrastructure to collect participant feedback using the validated Research Participant Perception Survey (RPPS), demonstrate its value in use cases, and disseminate it for broad adoption. METHODS/STUDY POPULATION: The EPV team developed data and survey implementation standards, and specifications for the dashboard and multi-lingual RPPS/REDCap project XML file. The VUMC built a custom At-a-Glance Dashboard external module that displays Top Box scores (percent best answer), with conditional formatting to aid analysis, and response/completion rates. Results populate site dashboards, and aggregate to a multi-site dashboard for benchmarking. Results can be filtered by participant/study characteristics. Sites developed individual use cases, leveraging local infrastructure, initiatives and stakeholder input. Infrastructure and guides were designed for dissemination through public websites. RESULTS/ANTICIPATED RESULTS: Five sites sent 23,797surveys via email, patient portal or SMS. 4,133 (19%) participants diverse in age, race, and ethnicity, returned responses. Sites analyzed their data and acted on selected findings, improving recruitment, communication and feeling valued. Aggregate scores for feeling listened to and respected were hight (>90%%); scores for feeling prepared by the consent process were lower (57-77%) and require action. Some groups experiences were better than others. Sites differed significantly in some scores. Dissemination of EPV is underway. Infrastructure and guides are downloadable free of charge, with advice from the EPV team. In 2023, a sixth site began piloting a lower literacy survey version and syncing data to the consortium dashboard. DISCUSSION/SIGNIFICANCE: The EPV RPPS/REDCap infrastructure enabled sites to collect participant feedback, identify actionable findings and benchmark with peers. Stakeholders and collaborators designed and tested local initiatives to increase responses and diversity, address disparities, and discover better practices.

Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.

The speed of stock price reaction to news exhibits substantial time variation. Higher risk-bearing capacity of financial intermediaries, lower passive ownership of stocks, and more informative news increase price responses to contemporaneous news; surprisingly, these interaction variables also increase price responses to lagged news (underreaction). A simple model with limited attention and three investor types (institutional, noninstitutional, and passive) predicts the observed variation in news responses. A long–short trading strategy based on news sentiment earns high returns, which increase when conditioning on the interaction variables. The interactions we document are robust to the choice of news source.

Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.

Significant progress has been made in designing magnetic fields that provide excellent confinement of the guiding-centre trajectories of alpha particles using quasisymmetry (QS). Given the reduction in this transport channel, we assess the impact of resonant Alfvén eigenmodes (AEs) on the guiding-centre motion. The AE amplitudes are chosen to be consistent with experimental measurements and large-scale simulations. We evaluate the drift resonance condition, phase-space island width and island overlap criterion for quasisymmetric configurations. Kinetic Poincaré plots elucidate features of the transport, including stiff transport above a critical perturbation amplitude. Our analysis highlights key departures from the AE-driven transport in tokamaks, such as the avoidance of phase-space island overlap in quasihelical configurations and the enhanced transport due to wide phase-space islands in low magnetic shear configurations. In configurations that are closer to QS, with QS deviations $\delta B/B_0 \lesssim 10^{-3}$, the transport is primarily driven by the AE, while configurations that are further from QS, $\delta B/B_0 \sim 10^{-2}$, experience significant transport due to the QS-breaking fields in addition to the AE.

Clinical trials face many challenges with meeting projected enrollment and retention goals. A study’s recruitment materials and messaging convey necessary key information and therefore serve as a critical first impression with potential participants. Yet study teams often lack the resources and skills needed to develop engaging, culturally tailored, and professional-looking recruitment materials. To address this gap, the Recruitment Innovation Center recently developed a Recruitment & Retention Materials Content and Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials. This paper seeks to describe the creation and contents of this new toolkit.