Core A: Administrative/Biostatistics Core

核心 A：行政/生物统计学核心

• 批准号: 10684186
• 负责人: Richard Charles Boucher
• 金额: $ 19.1万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684186
• 关键词: Accounting; Applied Research; Biometry; Biostatistics Core; Conflict of Interest; Consultations; Data; Data Analyses; Disease; Gland; Goals; Health; Human; Human Resources; Individual; Institutional Review Boards; Investigation; Lung; Manuscripts; Mathematics; Molecular; Mucins; Mucous body substance; Names; National Heart, Lung, and Blood Institute; Pharmacy (field); Preparation; Progress Reports; Provider; Research; Research Design; Research Personnel; Schedule; Services; Structure; Study Subject; Submucosa; design; forest; human subject; meetings; member; programs; respiratory; statistical service

CORE A ABSTRACT Core A, the Program Management and Biostatistics Core, is directed by Multi-PIs Drs. Richard C. Boucher and Michael Rubinstein and will have two major functions: 1) project coordination and administration to achieve PPG goals; and 2) provision of statistical assistance in study design and analysis. Oversight and assistance in guiding the overall scientific direction of the PPG will be provided by an Internal Advisory Board, consisting of: Drs. Richard Superfine, Chair, Department of Applied Sciences at UNC-CH; Dr. Greg Forest, Director, Carolina Center for Interdisciplinary Applied Mathematics at UNC-CH; and Dr. Sam Lai, Director, Pharmacoengineering Program, Division of Pharmacoengineering and Molecular Pharmaceutics at UNC-CH. Due to the nascent status of the PPG, the External Advisory Board will be named later. The program management functions of Core A will include: 1) budgetary and programmatic support; 2) facilitation of human subjects interactions with the relevant IRBs with respect to human materials for airway submucosal gland mucus studies; 3) conflict of interest management, with particular relevance to agents obtained via MTAs; 4) personnel support, interfacing the PPG to the UNC human resources departments; 5) manuscript preparation; 6) progress reports and correspondence with the NHLBI; 7) information handling, including dissemination of all research data in an appropriate and timely fashion; and 8) the coordination of a yearly External Advisory Board meeting. In parallel, biostatistics consultation, design, and analyses will be performed by Ms. Agathe Ceppe, who is a longstanding member of the Marsico Lung Institute as a provider of statistical services. Finally, the Program Management and Biostatistics Core will oversee all issues of PD/PI replacement designations, including those that may be relevant to the directorship of the PPG, individual projects, or individual cores.

核心A摘要 核心A，项目管理和生物统计学核心，由多PI博士指导。 鲍彻和迈克尔鲁宾斯坦，将有两个主要职能：1）项目协调， 管理，以实现PPG目标;和2）在研究设计中提供统计协助， 分析.将监督和协助指导项目规划小组的总体科学方向， 由内部咨询委员会提供，包括：Richard Superfine博士，系主任 格雷格森林，主任，卡罗莱纳跨学科中心 UNC-CH的应用数学;以及药物工程项目主任Sam Lai博士， 药物工程和分子药剂学分部在UNC-CH。 鉴于PPG的地位，外部咨询委员会将在稍后命名。节目管理 核心A的职能将包括：1）预算和方案支助; 2）促进人力资源开发; 受试者与相关IRB在气道人体材料方面的相互作用 粘膜下腺体粘液研究; 3）利益冲突管理，特别是与 通过MTA获得的代理; 4）人员支持，将PPG连接到安全人员 资源部门; 5）手稿准备; 6）进度报告和与 7）信息处理，包括以适当的方式传播所有研究数据; 及时; 8）协调年度外部咨询委员会会议。在 同时，Agathe Ceppe女士将进行生物统计学咨询、设计和分析， 他是Marsico Lung Institute的长期成员，是统计服务的提供者。 最后，项目管理和生物统计学核心将监督PD/PI的所有问题 替代任命，包括可能与PPG董事职位有关的任命， 单个项目或单个核心。