Human Subjects Core

人类受试者核心

• 批准号: 8740715
• 负责人: FREDERICK A MOORE
• 金额: $ 35.78万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8740715
• 关键词: Adverse event; Biological; Biological Markers; Biostatistics Core; Blood; Blood specimen; Caring; Case Report Form; Certificate of Confidentiality; Cessation of life; Characteristics; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical assessments; Consensus; Consent; Critical Care; Critical Illness; Data; Data Collection; Databases; Eligibility Determination; Enrollment; Exclusion Criteria; Exercise; Family; Florida; Goals; Health; Hospitals; Hour; Housing; Human Subject Research; Informed Consent; Institutional Review Boards; Intensive Care Units; Intervention; Intervention Trial; Laboratories; Laboratory Research; Laboratory Technicians; Longitudinal Studies; Measurement; Mechanical ventilation; Modeling; Monitor; National Institute of General Medical Sciences; Nursing Research; Operative Surgical Procedures; Outcome; Outcome Assessment; Participant; Patients; Performance; Policies; Procedures; Process; Protocols documentation; Reporting; Research; Research Activity; Research Personnel; Research Subjects; Risk; Safety; Sampling; Schedule; Sepsis; Services; Specialist; Specialized Center; Sum; Time; Trauma; Universities; Urine; base; clinical care; computerized; data management; design; follow-up; human subject; meetings; multidisciplinary; programs; response; septic; tool

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.

核心摘要 人类受试者核心是佛罗里达大学（UF）脓毒症和危重病的基本核心 研究中心（SCIRC）。人类受试者核心的主要功能如下： * 招募400名外科和创伤ICU患者作为研究受试者，这些患者筛选为脓毒症阳性， 由计算机化临床决策支持（CCDS）驱动的早期脓毒症管理。 * 使用REDCapTM病例报告表从知情同意的研究受试者中获取临床数据并上传 将这些数据输入位于数据管理和生物统计核心的SCIRC数据库。 * 在设定的时间点从知情同意的研究受试者中获取并初步处理血液和尿液样本 并将这些样本分发至生物分析核心实验室。 * 实施、监测和优化ICU护理标准操作程序（SOP）的合规性， 控制变量临床护理对结果变量的混杂效应。 * 建立个性化的研究受试者保留计划，通过长期的 在3、6和12个月时进行随访。 * 协助4号项目开展两项慢性危重病患者运动干预的试点临床试验 需要长时间机械通气的患者。 * 确保人类研究受试者的安全，包括IRB批准研究方案， 同意作为人类研究受试者参与;以及不良事件报告和安全性监测 指定IRB批准的方案。 人类受试者核心将监督所有患者的临床院内研究活动， 同意参与UF SCIRC计划的人类研究对象。具体来说，它将协调 与受试者的互动，以最大限度地提高研究效率。它将通过精心设计的 生物样品采集和性能测量或干预的时间表，以优化 患者及其家属的健康，因为他们通过研究协议的进展。