Human Subjects Core

人类受试者核心

基本信息

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
项目类别：
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

项目摘要

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的核心是佛罗里达大学（UF）败血症和危重疾病的重要核心研究中心（SCIRC）。人类主题核心的主要功能将包括以下内容： *招募400名手术和创伤ICU患者作为筛查败血症阳性的研究对象由计算机化的临床决策支持（CCDS）驱动的早期败血症管理。 *使用Redcaptm病例报告表并上传从同意的研究对象中获取临床数据这些数据进入数据管理和生物统计学核心中包含的SCIRC数据库。 *在设定的时间点获得并最初从同意研究对象中处理血液和尿液样本并将这些样品分发给生物分析核心实验室。 *实施，监视和优化遵守标准操作程序（SOP）以进行ICU护理控制可变临床护理对结果变量的混杂影响。 *建立个性化的研究主题保留计划，以长期最大化数据收集在3、6和12个月的随访。 *协助项目＃4进行两项试验性临床试验，以进行长期患病的运动干预措施需要延长机械通气的患者。 *确保人类研究对象的安全性，包括IRB批准研究方案，并告知同意作为人类研究主题参加；以及不良事件的报告和安全监控指定的IRB批准协议。人类受试者核心将为所有患者监督临床内院内研究活动同意作为人类研究对象参加UF SCIRC计划。具体而言，它将协调与受试者的相互作用以最大化研究效率。它将通过精心设计的生物样品采集和性能测量或干预措施的时间表以优化患者及其家人通过研究方案的福祉。