Core--Clinical

核心--临床

• 批准号: 6820202
• 负责人: Jeanine P Wiener-Kronish
• 金额: $ 38.76万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6820202
• 关键词: adult respiratory distress syndrome; biomedical facility; data management; human subject; medical outreach /case finding; patient oriented research

The Clinical Core will provide support for the two clinical projects, Project 1 (Matthay) and Project 2 (Wiener-Kronish). Essentially, this core will be a clinical coordinating center staffed to support the clinical studies. This clinical core will provide the organization, personnel and supplies for the screening and enrollment of eligible patients in the adult and pediatric intensive care units at Moffitt-Long Hospital and San Francisco General Hospital. The clinical core will also provide the support for acquisition and entry of patient data and patient specimens, data analysis, and monitoring of all aspects of the clinical studies so as to conform with Good Clinical Practice and NIHLBI, FDA, and UCSF IRB guidelines. This core will also provide statistical analysis of the data and the support to modify database collection as needed.

临床核心将为两个临床项目提供支持，即项目1（Matthay）和项目2（Wiener-Kronish）。从本质上讲，该核心将是一个临床协调中心，以支持临床研究。该临床核心将为莫菲特·朗医院和旧金山综合医院的成人和小儿重症监护病房的合格患者筛查和入学提供组织，人员和补给。临床核心还将为患者数据和患者标本的获取和进入，数据分析以及对临床研究的各个方面的监测提供支持，以符合良好的临床实践以及NIHLBI，FDA和UCSF IRB IRB指南。该核心还将提供数据的统计分析和根据需要修改数据库收集的支持。