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 项目负责人与核心B（高级蛋白质组表型核心）之间的互动 （APP）。核心将组织每月两小时的计划参与者TPPG会议，项目 领导者、合作者和顾问、生物统计学家、博士后研究员、研究助理和护士 协调员。每周，一名项目或核心领导人将负责科学议程。 行政核心将在最后半小时提出任何监管或程序问题。芯会 还与内部咨询委员会组织一次半年一次的会议，与外部咨询委员会组织一次年度会议， 咨询委员会。核心将协调学员的教育活动，包括促进学员的 访问培训计划（K12，T32）和博士后事务办公室提供的相关资源， 斯坦福大学。行政核心将与项目3负责人Zamanian博士和数据中心密切合作。 协调中心帮助组织I期和II期临床试验，包括协调与 II期临床试验的其他研究中心负责人，以及与DSMB、医学伦理委员会的沟通 和项目经理。核心将作为项目负责人和Proteo（我们的商业 合作伙伴和IND申办者）以及项目3负责人和SRI international之间关于180天GLP的沟通 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。的 Core还将促进与NIH SMARTT项目的互动，以在提交IND时提供监管帮助， 在启动II期临床试验之前，准备与FDA的快速通道会议。行政 Core还将担任项目负责人、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。芯会 促进出版物、演讲和进展报告的准备。