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.

一个充满活力的翻译信息学生态系统需要跨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）。调查人员面临挑战 在安全的符合HIPAA的分析环境中快速访问集成数据集， 注释、可复制的分析以及开放存取存档和共享。借助社交媒体、移动的应用程序， 可穿戴设备，消费者是一个额外的合作伙伴。基于云的架构提供了新的 在安全的可扩展环境中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中心和新的CTSA试验创新“合作良好”的环境 网络一个新的挑战是实现临床、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 结果和持续的安全监测。真正的数据流动性需要集成信息学工具， 临床护理或患者互动点，包括社交媒体和电子健康环境，需要新的 与机构卫生信息技术（IT）业务合作伙伴的关系，基于社区的 合作者和创新的互联网/社交媒体/移动精明的公司。迄今为止，CCTSI信息学 支柱计划通过使调查人员能够遵循 通过免费访问安全的用户友好型数据管理服务，提供最佳做法。我们目前的目标 重点关注操作、科学（生物学、临床、人口）、患者/家庭之间的联系和工作流程， 消费者数据所有者可以随时最大限度地提高从任何来源到任何地点的数据流动性， 强大的安全性、合规性和保密性控制。我们将通过以下方式实现这些目标 具体目标：目标1：我们将使用以下工具链接和协调行政、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， 纵向数据资产，专门用于支持大规模的转化研究。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：整合研究数据 将生命周期纳入临床护理实践和以患者为中心的场所。目标4：我们将扩大在线教育 资源，以突出下一代研究数据基础设施，数据标准和注释， 可复制的研究和数据共享的最佳做法。消除将临床研究和 临床护理系统是必要的“闭环”与无缝的参与者通知和招募，试验 招募、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 安全、合规的环境。与新的试验创新网络合作，信息学 计划目标围绕这些目标建立，并提供研究者教育和支持， 这些新技术。