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.

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 IntCal family of radiocarbon (14C) calibration curves is based on research spanning more than three decades. The IntCal group have collated the 14C and calendar age data (mostly derived from primary publications with other types of data and meta-data) and, since 2010, made them available for other sorts of analysis through an open-access database. This has ensured transparency in terms of the data used in the construction of the ratified calibration curves. As the IntCal database expands, work is underway to facilitate best practice for new data submissions, make more of the associated metadata available in a structured form, and help those wishing to process the data with programming languages such as R, Python, and MATLAB. The data and metadata are complex because of the range of different types of archives. A restructured interface, based on the “IntChron” open-access data model, includes tools which allow the data to be plotted and compared without the need for export. The intention is to include complementary information which can be used alongside the main 14C series to provide new insights into the global carbon cycle, as well as facilitating access to the data for other research applications. Overall, this work aims to streamline the generation of new calibration curves.

OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a Rockefeller-led 6-CTSA consortium that aims to collect research participant feedback through new Research Participant Perception Survey (RPPS)/REDCap infrastructure and data aggregation to a national database. Here we describe diverse Use Cases and launch dissemination to other hubs. METHODS/STUDY POPULATION: The EPV team refined the RPPS-S and developed fielding and data standards, a multi-lingual RPPS/REDCap project XML, At-a-Glance Dashboard, EPV Consortium Database, and Use Cases to align with local initiatives and stakeholder input. Sites ran full thread tests of the infrastructure before launch. To demonstrate RPPS/REDCap, 5 sites implemented Use Cases, surveyed diverse populations via email, patient portal or SMS, and analyzed results using the At-a-Glance Dashboard External module (which provides visual analytics and enables filtering by participant/study characteristics). Sites continue to collect, synthesize and respond to actionable data. To disseminate infrastructure, we will invite early adopters to implement the RPPS/REDCap infrastructure locally, joining the EPV learning collective. RESULTS/ANTICIPATED RESULTS: To date, 5 sites surveyed 10,199 research participants, at post-consent or end of study. 2833 (26%) research participants responded, from diverse demographic groups. More than 90% gave the Top Box score response regarding courtesy, respect for cultural background, privacy, and lack of pressure to join a study. Disparities were apparent in the informed consent experience, with a Top Box score range of 38-78% in different demographics. Dissatisfaction with out-of-pocket research costs was a recurring theme. Top Box scores varied for feeling like a valued partner in research (69-93%), would recommend research participation to friends or family (56%-81%), and Overall Experience (64%-90%) questions. Sites identified actionable findings in areas of consent, communication, partnership, and study conduct. DISCUSSION/SIGNIFICANCE: The EPV RPPS/REDCap infrastructure enabled sites to broadly collect participant feedback, identify actionable findings and make inter-institutional comparisons. Collaborators are designing local initiatives to increase response rate and diversity, address disparities in research participation experiences, and discover better practices.

OBJECTIVES/GOALS: Six CTSA sites formed a collaboration to DEVELOP, DEMONSTRATE, AND DISSEMINATE new infrastructure to streamline collection and analysis of research participant feedback, using the Research Participant Perception Survey (RPPS), common standards, and customized REDCap-based tools, to improve the clinical research enterprise. METHODS/STUDY POPULATION: DEVELOP charter, consensus approach, core survey, deployment standards, data-use agreements; define meta-data, system requirements for the infrastructure, use-cases. Engage stakeholders for broad institutional and community input. Build RPPS/REDCap project, visual analytics Dashboard External Module, and Program Dashboard module for evaluation. Configure to use with Multilingual Module. DEMONSTRATE by implementing site-based use cases that reflect local priorities and span diverse populations, testing different methods of survey deployment (REDCap, patient portal, SMS) to showcase utility and flexibility. Generate data for local and inter-institutional benchmarking. Refine, then DISSEMINATE new infrastructure across the Consortium and REDCap community for broader testing and uptake. RESULTS/ANTICIPATED RESULTS: The project team refined the RPPS survey for inclusivity and mode of informed consent; defined standards for survey timing, sampling, and study metadata; configured the data dictionary in English and Spanishfor use with the multi-lingual module ; developed tools for project evaluation. Stakeholder engagement identified themes of anticipated value and fears about feedback. We designed an At-a-Glance Dashboard to display survey results with detailed analytics and filters. A REDCap application programming interface will send de-identified site data to the EPV Consortium Database to support benchmarking. Full implementation began November 2021 and will scale in 2022. Dissemination to Consortium and REDCap users is ongoing through presentations and a project website (www.Rockefeller.edu/research/epv). DISCUSSION/SIGNIFICANCE: Direct feedback from representative populations about their experiences in research is essential to understand and resolve barriers to broad participation in research. Streamlined RPPS/REDCap infrastructure provides a platform for local and national benchmarking, and collection of actionable data to improve clinical research.

Radiocarbon (14C) ages cannot provide absolutely dated chronologies for archaeological or paleoenvironmental studies directly but must be converted to calendar age equivalents using a calibration curve compensating for fluctuations in atmospheric 14C concentration. Although calibration curves are constructed from independently dated archives, they invariably require revision as new data become available and our understanding of the Earth system improves. In this volume the international 14C calibration curves for both the Northern and Southern Hemispheres, as well as for the ocean surface layer, have been updated to include a wealth of new data and extended to 55,000 cal BP. Based on tree rings, IntCal20 now extends as a fully atmospheric record to ca. 13,900 cal BP. For the older part of the timescale, IntCal20 comprises statistically integrated evidence from floating tree-ring chronologies, lacustrine and marine sediments, speleothems, and corals. We utilized improved evaluation of the timescales and location variable 14C offsets from the atmosphere (reservoir age, dead carbon fraction) for each dataset. New statistical methods have refined the structure of the calibration curves while maintaining a robust treatment of uncertainties in the 14C ages, the calendar ages and other corrections. The inclusion of modeled marine reservoir ages derived from a three-dimensional ocean circulation model has allowed us to apply more appropriate reservoir corrections to the marine 14C data rather than the previous use of constant regional offsets from the atmosphere. Here we provide an overview of the new and revised datasets and the associated methods used for the construction of the IntCal20 curve and explore potential regional offsets for tree-ring data. We discuss the main differences with respect to the previous calibration curve, IntCal13, and some of the implications for archaeology and geosciences ranging from the recent past to the time of the extinction of the Neanderthals.