Clinical Core

临床核心

• 批准号: 7922632
• 负责人: Rolf D Hubmayr
• 金额: $ 39.69万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7922632
• 关键词: Acute Lung Injury; Adverse event; Antibodies; Clinic; Clinical; Clinical Data; Communication; Data; Data Reporting; Databases; Ensure; Guidelines; HLA Antigens; Human Resources; Internet; Laboratories; Liquid substance; Monitor; National Heart, Lung, and Blood Institute; Patients; Plasma; Probability; Pulmonary Edema; Radiology Specialty; Reporting; Research; Research Ethics Committees; Safety; Sampling; Site; Specimen; Testing; Transfusion; base; clinical practice; laboratory facility; lung injury; repository

INTRODUCTION. The Clinical Core (Core C) will support the two clinical projects, Projects 1 and 2. For both UCSF and Mayo sites, Core C will be responsible for (1) a sample repository, including storage and appropriate distribution of all biologic specimens, (2) establishing and managing a web-entry central database, (3) establishing the pre-test probability of any Transfusion Related Acute Lung Injury (TRALI) based on a post hoc expert review of radiology and clinical data, (4) providing laboratory facilities and personnel for HLA antigen/antibody testing of donor and recipient plasma, and finally (5) ensuring data safety and monitoring aspects of the research so as to conform to Good Clinical Practice and to NHLBI and local IRB guidelines.

介绍。临床核心（核心C）将支持两个临床项目，即项目1和2。 UCSF和Mayo站点均应负责（1）样本存储库，包括存储和 适当分发所有生物标本，（2）建立和管理网络进入中央数据库， （3）基于邮政 HOC专家审查放射学和临床数据，（4）为HLA提供实验室设施和人员 供体和受体血浆的抗原/抗体测试，最后（5）确保数据安全和监测 研究的各个方面，以符合良好的临床实践以及NHLBI和本地IRB指南。