Human Subjects Core

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CORE ABSTRACT The Human Subjects Core is an essential core for the University of Florida (UF) Sepsis and Critical Illness Research Center (SCIRC). The Human Subject Core's main functions will be the following: * Enroll 400 surgery and trauma ICU patients as research subjects who screen positive for sepsis and are managed by computerized clinical decision support (CCDS)-driven early sepsis management. * Obtain clinical data from consented research subjects using the REDCapTM case report form and upload these data into the SCIRC database housed in the Data Management and Biostatistics Core. * Obtain and initially process blood and urine samples from consented research subjects at set time points and distribute these samples to the Bioanalytical Core laboratories. * Implement, monitor, and optimize compliance to standard operating procedures (SOPs) for ICU care to control the confounding effects of variable clinical care on outcome variables. * Establish an individualized research subject retention plan to maximize data collection through long-term follow-up at 3, 6, and 12 months. * Assist Project #4 in conducting two pilot clinical trials of exercise interventions in chronically critically ill patients who require prolonged mechanical ventilation. * Assure safety of human research subjects, including IRB approval of research protocols, informed consents to participate as human research subjects; and adverse-event reporting and safety monitoring of designated IRB-approved protocols. The Human Subjects Core will supervise the clinical in-hospital research activities for all the patients who agree to participate as human research subjects in the UF SCIRC program. Specifically, it will coordinate interactions with the subjects to maximize research efficiency. It will achieve this through carefully designed schedules for biological sample acquisition and performance measurements or interventions to optimize the wellbeing of the patients and their families as they progress through the research protocols.