Core-001

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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.