Core-001

核心001

• 批准号: 10414768
• 负责人: RONALD J. SOKOL
• 金额: $ 103.86万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-11-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414768
• 关键词: Architecture; Archives; Biological; Clinical; Clinical Research; Collaborations; Colorado; Communities; Coupled; Data; Data Collection; Data Set; Ecosystem; Education; Enrollment; Environment; Face; Family; Fostering; Goals; Health Insurance Portability and Accountability Act; Informatics; Infrastructure; Institutes; Internet; Link; Liquid substance; Monitor; Movement; Notification; Outcome; Participant; Patient Recruitments; Patients; Play; Population; Public Health; Reproducibility; Research; Research Personnel; Safety; Science; Secure; Security; Services; Source; Technology; Time; Translational Research; analytical tool; base; care systems; clinical care; cloud based; cost; data infrastructure; data integration; data management; data sharing; data standards; data warehouse; eHealth; education resources; health data; health information technology; informatics tool; innovation; mobile application; network informatics; new technology; next generation; patient oriented; programs; recruit; social media; user-friendly; wearable device

A vibrant translational informatics ecosystem requires technical and organizational engagement across the research data lifecycle (data collection, storage, analytics, sharing, and reuse). Investigators face challenges rapidly accessing integrated data sets in secure HIPAA-compliant analytic environments with support for data annotation, reproducible analytics, and open access archiving and sharing. With social media, mobile apps, and wearable devices, consumers are an additional collaborating partner. Cloud-based architectures offer new opportunities to rapidly configure and deploy informatics technologies and analytic tools in a secure scalable environment that “plays well” with external data partners, other CTSA Hubs, and the new CTSA Trial Innovation Network. A new challenge is enabling the seamless movement of data between clinical, personal, and research environments to support point-of-contact/personalized patient recruitment, real-time trial tracking, patientreported outcomes, and continuous safety monitoring. True data liquidity requires integrating informatics tools at the point of clinical care or patient interaction, including social media and eHealth environments, requiring new relationships with institutional Health Information Technology (IT) operational partners, community-based collaborators, and innovative Internet/social media/mobile-savvy companies. To date, the CCTSI Informatics Pillar Program has fostered regulatory compliance and good data practices by enabling investigators to follow best-practices via no-cost access to secure user-friendly data management services. Our current objectives focus on linkages and workflows across operational, scientific (biological, clinical, population), patient/family, and consumer data owners to maximize data liquidity from any source to any place at any time while maintaining robust security, compliance, and confidentiality controls. We will achieve these goals through the following Specific Aims: Aim 1:We will link and harmonize administrative, biological, clinical, and public health data using our existing NIST 800-53 compliant secure research data warehouse data integration pipelines to create rich longitudinal data assets specifically to support broad-scale translational research. Aim 2:We will implement new infrastructure that supports data sharing and reproducible research. Aim 3: We will integrate the research data lifecycle into clinical-care practice and in patient-centered venues. Aim 4: We will expand our online educational resources to highlight next-generation research data infrastructures, data standards and annotation, reproducible research and data sharing best-practices. Eliminating barriers that separate clinical research and clinical care systems is necessary to “close the loop” with seamless participant notification and recruitment, trial enrollment, efficient trial execution, and rapid dissemination of new translational discoveries, all within a data secure and compliant environment. In collaboration with the new Trial Innovation Network, the Informatics Program Aims are built around these objectives coupled with providing investigator education and support for these new technologies.

充满活力的转化信息学生态系统需要整个领域的技术和组织参与 研究数据生命周期（数据收集、存储、分析、共享和重用）。 通过数据支持，在符合 HIPAA 的安全分析环境中快速访问集成数据集 通过社交媒体、移动应用程序和共享进行注释、可重复分析以及开放访问归档和共享。 可穿戴设备中，消费者是一个额外的合作伙伴，基于云的架构提供了新的机会。 以安全、可扩展的方式快速配置和部署信息技术和分析工具的机会 与外部数据合作伙伴、其他 CTSA 中心以及新的 CTSA 试验创新“良好配合”的环境 网络的一个新挑战是实现临床、个人和研究之间的数据无缝移动。 支持接触点/个性化患者招募、实时试验跟踪、患者报告的环境 结果和持续的安全监控需要集成信息学工具。 临床护理或患者互动的点，包括社交媒体和电子医疗环境，需要新的 与基于社区的机构卫生信息技术 (IT) 运营合作伙伴的关系 迄今为止，CCTSI 信息学。 支柱计划通过使调查人员能够遵循来促进监管合规性和良好的数据实践 通过免费访问安全、用户友好的数据管理服务来实现最佳实践 我们当前的目标。 重点关注跨操作、科学（生物、临床、人群）、患者/家庭和 消费者数据所有者可以最大限度地提高从任何来源到任何地点的数据流动性，同时保持 我们将通过以下措施实现这些目标。 具体目标： 目标 1：我们将使用以下方法链接和协调行政、生物、临床和公共卫生数据： 我们现有的符合 NIST 800-53 标准的安全研究数据仓库数据集成管道可创建丰富的 专门支持大规模转化研究的纵向数据资产 目标 2：我们将实施新的。 支持数据共享和可重复研究的基础设施。目标 3：我们将整合研究数据。 目标 4：我们将扩展我们的在线教育。 强调下一代研究数据基础设施、数据标准和注释的资源， 可重复的研究和数据共享最佳实践，消除临床研究和数据共享之间的障碍。 临床护理系统需要通过无缝的参与者通知和招募、试验来“闭环” 登记、高效试验执行以及新转化发现的快速传播，所有这些都在数据中 与新的试验创新网络、信息学合作。 计划目标是围绕这些目标建立的，并为研究者提供教育和支持 这些新技术。