Clinical Core

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Project Summary The Clinical Core of the P01, High resolution longitudinal immune monitoring for elucidating immune aging dynamics, will provide state-of-the-art biospecimen support for both all the P01 human research projects, and cores, as well as the personnel, procedures and processes for the implementation and management of the proposed clinical project. The Clinical Core will orchestrate the clinical research effort of the P01, including: co- developing (with NIAID/NIA) and curating clinical protocols and documents; providing and updating training for clinical investigators and staff; organizing, implementing, monitoring and working to improve clinical project performance; and conducting quality control and corrective action (if needed), including assuring adherence to milestones, project performance expectations, and clinical Good Practice Guidelines. Our Specific Tasks are: 1) Obtain biospecimens for Projects 1 and 2. Both projects will not access any protected health information (PHI). 2) Establish and maintain the personnel, procedures and processes that the P01 will use to provide core clinical support. 3) Establish and maintain protocol milestones, performance guidelines, compliance, participant recruitment, and retention for clinical study and sample collection. The Clinical Core will engage state-of-the-art biospecimen services to support P01 research and will apply decades of first-rate experience in successful clinical project management to produce outstanding and rigorous research to make a transformative impact in results obtained for the P01.