RADx-UP CDCC

摘要 迫切需要减少COVID-19相关发病率和死亡率结果的差异， 受COVID-19大流行不成比例影响的历史边缘化和弱势群体。到 为满足这一需求，快速加速服务不足人群诊断（RADx-UP）计划将 支持社区可持续发展测试研究项目及社会、道德和行为影响 （SEBI）研究项目，以了解SARS-CoV-2感染模式，并增加获得和 诊断方法在服务不足和/或弱势群体中的有效性。杜克临床研究 研究所（DCRI），健康公平研究中心（CHER）和社区校园合作伙伴关系 卫生部（CCPH）建议作为协调和数据收集中心（CDCC）， RADx-UP联盟的管理、指导和总体协调。我们的多学科团队 项目协调经验; COVID-19思想领导力;监管科学;社区参与; 健康公平研究;社会正义;成人和儿童研究;统计学;数据科学;和临床研究 信息学将推进RADx-UP计划中项目的目标。我们的首要目标是 实施以社区为中心的方法，建立有效、灵活、参与性和可持续的 CDCC将作为基础设施，以最大限度地提高RADx-UP项目的社区影响力 程序.为了实现这一愿景，我们将建立一个由四个核心组成的计划框架。我们 行政和协调核心与NIH科学工作人员合作，将促进 RADx-UP计划在总体行政管理。COVID-19测试核心将提供建议， 指导COVID-19检测方案;管理紧急检测数据;管理快速试点研究 程序.社区和卫生系统参与核心将支持整个社区的实践 RADX-UP计划;为跨社区交流招聘最佳实践提供支持， 参与和保留研究参与者;并协调研究结果的传播， RADx-UP项目。数据科学和生物统计学核心将管理数据收集，整合和 RADx-UP计划的共享，包括合并和协调多个不同的数据源 提供数据标准、数据采集设计、生物统计咨询服务。RADx-UP CDCC 将利用已建立的基础设施和主题专家来实现目标，并将进行定制，以满足 RADx-UP社区的各种需求。使用最高的研究标准，我们的团队将 实现NIH在管理这一至关重要的合作努力方面设定的目标。

ABSTRACT There is an urgent need to reduce disparities in COVID-19 associated morbidity and mortality outcomes in historically marginalized and vulnerable populations disproportionately affected by the COVID-19 pandemic. To address this need the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) program will support Community-Engaged Testing Research Projects and Social, Ethical and Behavioral Implications (SEBI) Research Projects to understand SARS-CoV-2 infection patterns and increase access and effectiveness of diagnostic methods in underserved and/or vulnerable populations. The Duke Clinical Research Institute (DCRI), the UNC Center for Health Equity Research (CHER), and Community-Campus Partnerships for Health (CCPH) propose to serve as the Coordination and Data Collection Center (CDCC) to provide management, direction, and overall coordination of the RADx-UP consortium. Together, our multidisciplinary experience in project coordination; COVID-19 thought leadership; regulatory science; community engagement; health equity research; social justice; adult and child research; statistics; data science; and clinical research informatics will advance the objectives of the projects in the RADx-UP Program. Our overarching goal is to implement a community-centered approach and establish an effective, flexible, participatory, and sustainable CDCC that will serve as the infrastructure to maximize the community impact of projects in the RADx-UP Program. To achieve this vision, we will establish a program framework comprised of four cores. Our Administration and Coordination Core, in collaboration with NIH scientific staff, will facilitate the work of the RADx-UP Program in overarching administrative management. The COVID-19 Testing Core will advise and guide COVID-19 testing protocols; curate emergent testing data; and administer the Rapid Pilot Studies Program. The Community and Health System Engagement Core will support a community of practice across the RADx-UP Program; provide support in exchanging best practices across communities on recruitment, engagement, and retention of study participants; and coordinate the dissemination of study findings from RADx-UP projects. The Data Science and Biostatistics Core will manage data collection, integration, and sharing for the RADx-UP Program including merging and harmonization of multiple and diverse data sources and provide data standards, data collection design, and biostatistics consulting services. The RADx-UP CDCC goals will be met using established infrastructure and subject matter experts and will be customized to meet the variable needs of the RADx-UP community. Using the highest research standards, our team will accomplish the goals set out by the NIH in managing this critically important collaborative effort.