Administrative core

行政核心

• 批准号: 7843284
• 负责人: NIZAR N JARJOUR
• 金额: $ 11万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7843284
• 关键词: Antibodies; Collaborations; Communication; Data; Goals; Head; Institutes; Investigational New Drug Application; Leadership; Manuscripts; National Heart, Lung, and Blood Institute; Notification; Preparation; Principal Investigator; Progress Reports; Research Ethics Committees; Role; Sample Size; Slide; Vertebral column; Work; airway inflammation; eosinophil; meetings

The administrative core will provide the organizational backbone for the overall proposal, coordinating the internal interactions between Projects and Cores as well as the external communication with NHLBI through the following specific aims: Specific Task 1: To facilitate communication between Projects 1-4 and Cores A and B and assist all projects in manuscript preparation. > Specific Task 2: To provide mechanisms for communication between UW, the Institute and project reviewers. Specific Task 3: To provide regulatory support to all projects and cores through interactions with the UW IRB and the FDA. The administrative core will interact with all projects and cores in this proposal through organization, notification and meeting minute distribution of monthly internal project review meetings. The administrative core will oversee the rate of subject accrual to assure that each project is able to meet its required sample size. The core will be responsible for preparation and submission of annual progress reports to the Institute and will organize external reviews as needed and the core will work with the FDA to obtain an Investigational New Drug application for the proposed use of anti-IL-5 antibody. The administrative core will assist all projects in collaborative manuscript preparation and preparation of slides for data presentations.

行政核心将为总体提案提供组织骨干，协调 项目与核心之间的内部互动以及通过以下方式与NHLBI进行的外部沟通 具体目标如下： 具体任务1：促进项目1-4与核心A和B之间的沟通，并协助所有项目 在手稿准备。> 具体任务2：为华盛顿大学、研究所和项目之间的沟通提供机制 审稿人。 具体任务3：通过与UW IRB的互动，为所有项目和核心提供监管支持 和食品药品管理局 行政核心将通过组织与本提案中的所有项目和核心互动， 每月内部项目审查会议的通知和会议记录分发。行政 核心将监督受试者的累积率，以确保每个项目能够满足其所需的样本 尺寸该核心将负责编写并向研究所提交年度进展报告 并将根据需要组织外部审查，核心将与FDA合作， 拟使用抗IL-5抗体的新药申请。行政核心将协助所有 合作编写手稿和准备数据演示用幻灯片的项目。