Core A: Administrative Core

核心A：行政核心

• 批准号: 10205141
• 负责人: Marlene Rabinovitch
• 金额: $ 13.42万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-17 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10205141
• 关键词: Animals; Clinical Protocols; Communication; Contracts; Data Coordinating Center; Development; Drug Kinetics; Educational Activities; Hour; Informed Consent; Institutional Review Boards; International; Medical; Monitor; Nurses; PI3 gene; Participant; Phase I Clinical Trials; Phase II Clinical Trials; Phenotype; Postdoctoral Fellow; Preparation; Progress Reports; Proteomics; Publications; Published Comment; Rattus; Resources; Running; SECTM1 gene; Site; Training Programs; United States National Institutes of Health; Update; Work; immunogenicity; meetings; phase 1 study; preclinical study; programs; pulmonary arterial hypertension; symposium

The Administrative Core (Core A), headed by the Program Director Dr. Rabinovitch, will oversee the interactions between the Leaders of the Projects and Core B, the Advanced Proteomic Phenotyping Core (APP). The Core will organize monthly two-hour TPPG meetings of the program participants, i.e., project leaders, collaborators and consultants, biostatisticians, postdoctoral fellows, research associates and nurse coordinators. Each week, one of the Projects or Core Leaders will be responsible for the scientific agenda. The Administrative Core will present any regulatory or procedural issues in the last half hour. The Core will also organize a bi-annual meeting with the Internal Advisory Board and an annual meeting with the External Advisory Board. The Core will coordinate educational activities of the trainees, including facilitation of trainee's access to relevant resources offered by training programs (K12, T32) and the Office of Postdoctoral Affairs at Stanford. The Administrative Core will work closely with Project 3 leader, Dr. Zamanian, and the Data Coordinating Center to help organize the Phase I and II clinical trials, including coordination of meetings with the other site directors for the Phase II clinical trial, and communication with the DSMB, the Medical Monitors and Program Managers. The Core will act as liaison between the project leaders and Proteo (our commercial partner and IND Sponsor) and between the Project 3 Leader and SRI international, regarding the 180 day GLP study in the rats and the pharmacokinetic and immunogenicity studies in the Phase I and II clinical trials. The Core will also facilitate interaction with the NIH SMARTT program, for regulatory help in filing the IND and in preparing for the fast track meeting with the FDA prior to initiating the Phase II clinical trial. The Administrative Core will also act as liaison between the Project Leaders, Proteo and the FDA. The Core will assist with preparation and updating of animal and clinical protocols, and with obtaining IRB approvals. The Core will facilitate the preparation of publications, presentations and progress reports.

由项目主任 Rabinovitch 博士领导的行政核心（核心 A）将监督 项目领导者与核心 B（高级蛋白质组表型分析核心）之间的互动 （应用程序）。核心将每月组织项目参与者举行两小时的 TPPG 会议，即项目 领导者、合作者和顾问、生物统计学家、博士后研究员、研究员和护士 协调员。每周，一名项目或核心领导者将负责科学议程。 行政核心将在最后半小时内提出任何监管或程序问题。核心将 还与内部顾问委员会组织一次半年会议，并与外部顾问委员会组织一次年度会议 顾问委员会。核心将协调受训者的教育活动，包括促进受训者的 获得培训项目（K12、T32）和博士后事务办公室提供的相关资源： 斯坦福。行政核心将与项目 3 负责人 Zamanian 博士以及数据部门密切合作 协调中心帮助组织 I 期和 II 期临床试验，包括协调与 II 期临床试验的其他现场主管，以及与 DSMB、医疗监察员的沟通 和项目经理。 Core 将充当项目领导者和 Proteo（我们的商业 合作伙伴和 IND 赞助商）以及项目 3 负责人和 SRI 国际之间关于 180 天 GLP 的事宜 大鼠研究以及 I 期和 II 期临床试验中的药代动力学和免疫原性研究。这 Core 还将促进与 NIH SMARTT 计划的互动，为提交 IND 和 在启动 II 期临床试验之前准备与 FDA 的快速通道会议。行政部门 Core 还将充当项目负责人、Proteo 和 FDA 之间的联络人。核心将协助 准备和更新动物和临床方案，并获得 IRB 批准。核心将 促进出版物、演示文稿和进度报告的准备。