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.

核心摘要 核心 A，即项目管理和生物统计核心，由多位 PI 博士指导。理查德·C. Boucher 和 Michael Rubinstein 将承担两大职能：1）项目协调和 实现 PPG 目标的管理； 2) 在研究设计和 分析。监督和协助指导 PPG 的整体科学方向 由内部顾问委员会提供，包括： Drs.理查德·超法恩（Richard Superfine），系主任 UNC-CH应用科学系； Greg Forest 博士，卡罗莱纳跨学科中心主任 UNC-CH 应用数学；以及药物工程项目主任 Sam Lai 博士， UNC-CH 药物工程和分子药剂学部。由于刚萌芽 PPG 的地位，外部顾问委员会将在稍后任命。计划管理 核心 A 的职能包括： 1) 预算和计划支持； 2）便利人类 受试者与相关 IRB 就气道人体材料进行互动 粘膜下腺粘液研究； 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 与 UNC 人员连接 资源部门； 5）稿件准备； 6) 进度报告和信函 NHLBI； 7) 信息处理，包括以适当的方式传播所有研究数据 以及及时的时尚； 8) 协调外部顾问委员会年度会议。在 同时，生物统计学咨询、设计和分析将由 Agathe Ceppe 女士进行， 他是 Marsico 肺脏研究所的长期会员，提供统计服务。 最后，项目管理和生物统计核心将监督 PD/PI 的所有问题 替换任命，包括可能与 PPG 董事职位相关的任命， 单个项目或单个核心。