Administrative Core

行政核心

• 批准号: 10478144
• 负责人: Elizabeth J Shpall
• 金额: $ 18.81万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-22 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10478144
• 关键词: Address; Biometry; Biotechnology; Blood Banks; Budgets; Cancer Center; Cell Therapy; Cells; Child; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Collaborations; Communication; Data Collection; Development; Disputes; Ensure; Equilibrium; Evaluation; Freezing; Funding; Funding Agency; Goals; Grant; Group Meetings; Health system; Human Resources; Individual; Infrastructure; Institution; Institutional Review Boards; Investigation; Investigational Drugs; Jordan; Lead; Leadership; Measurement; Medicine; Operations Research; Oranges; Patients; Principal Investigator; Productivity; Program Research Project Grants; Publications; Recombinant DNA; Recommendation; Regulatory Affairs; Reporting; Research; Research Personnel; Research Project Grants; Resource Sharing; Services; Structure; Supervision; Translations; Umbilical Cord Blood; United States Food and Drug Administration; United States Health Resources and Services Administration; United States National Institutes of Health; Universities; Validation; Visit; Washington; college; meetings; novel; operation; pre-clinical; preclinical study; programs; recruit

PROJECT SUMMARY The Administrative Core is responsible for the operations, communications, regulatory and financial oversight of the program, as well as supervision of the conduct of the proposed grant. The program is highly integrated and the preclinical and scientific studies impact directly on development of the translational clinical research protocols. The Administrative Core supervises the operations of the program and facilitates reports, communication between investigators and visits of our internal and external advisors as well as outside investigators. Clinical trials for this PO1 are only conducted at the two lead institutions, MD Anderson Cancer Center (MDACC) under the leadership of Dr. Elizabeth Shpall and Children's National Health System (CNHS) under the leadership of Dr. Catherine Bollard. Pre-clinical studies will be performed at the other three PO1 institutions in conjunction with the PO1 Project leaders including Harvard University (Project 1-Dr. Robert Sackstein and Dr. Shpall), George Washington University (Project 2- Dr. Douglas Nixon and Dr. Bollard) and Baylor College of Medicine (BCM) (Project 3- Dr Jordan Orange and Dr. Katy Rezvani). The two Core A leaders, Drs. Shpall and Bollard have been working together closely since 2004. They have developed a sustained and in depth collaboration, which began when Dr Bollard was at BCM and was transferred seamlessly to CNHS when she was recruited there in 2012. The core supports the Institutional Review Board (IRB), Food and Drug Administration (FDA) Investigational New Drug (IND), Investigational Biosafety Committee (IBC), and National Institutes of Health Office of Biotechnology Activities Recombinant DNA Committee (NIH/OBA/RAC) submissions and reporting required for clinical protocols in the P01. The core manages program personnel, accounts and budgets for each section of the grant, including ongoing reports of account balances for the investigators. The core is responsible for preparing the necessary reports to the funding agency, for the research projects and publications. This shared resource core is an essential and critical part of this PO1. The proposed services will facilitate the communication between the investigators and our advisors; facilitate the translation of the pre-clinical projects to the clinic by procuring all the requisite IND and RAC approvals in addition to providing on-going reports to the agencies, and will provide CB units to all four projects as well as Cores C to accomplish the proposed goals and objectives of the PO1. Centralizing these functions assures maximal efficiency, integration, consistency and oversight, which would not be possible if each Project and Core were individually responsible for performing the services.

项目概要 行政核心负责运营、沟通、监管和 对该计划进行财务监督，并监督拟议赠款的实施。 该计划高度集成，临床前和科学研究直接影响 制定转化临床研究方案。行政核心监督 该计划的运作并促进报告以及调查人员之间的沟通 我们的内部和外部顾问以及外部调查员的访问。这方面的临床试验 PO1 仅在两个主要机构 MD 安德森癌症中心 (MDACC) 进行 在 Elizabeth Shpall 博士和儿童国家卫生系统 (CNHS) 的领导下 在 Catherine Bollard 博士的领导下。临床前研究将在其他机构进行 包括哈佛大学在内的三个 PO1 机构与 PO1 项目负责人合作 （项目 1 - 罗伯特·萨克斯坦博士和 Shpall 博士），乔治华盛顿大学（项目 2 - 罗伯特·萨克斯坦博士和 Shpall 博士） 道格拉斯·尼克松 (Douglas Nixon) 和 Bollard 博士) 和贝勒医学院 (BCM)（项目 3-乔丹博士） 奥兰治和凯蒂·雷兹瓦尼博士）。两位核心 A 领导人，博士。什波尔和博拉德 自 2004 年以来一直密切合作。他们已经形成了持续、深入的合作关系 合作始于 Bollard 博士在 BCM 时，并无缝转移到 2012 年，她被招募到 CNHS。核心支持机构审查委员会 (IRB)、美国食品药品监督管理局 (FDA) 研究性新药 (IND)、研究性新药 生物安全委员会 (IBC) 和美国国立卫生研究院生物技术活动办公室 临床所需的重组 DNA 委员会 (NIH/OBA/RAC) 提交和报告 P01 中的协议。核心管理每个项目的人员、账户和预算 赠款的一部分，包括为研究人员提供的账户余额的持续报告。这 核心负责为资助机构准备必要的研究报告 项目和出版物。这个共享资源核心是 PO1 的重要组成部分。 拟议的服务将促进调查人员和我们之间的沟通 顾问；通过采购所有的材料，促进临床前项目向临床的转化 除了向机构提供持续报告外，还需要获得必要的 IND 和 RAC 批准，以及 将为所有四个项目以及核心 C 提供 CB 单元，以实现拟议目标 PO1 的目标。集中这些功能可确保最大的效率、集成、 一致性和监督，如果每个项目和核心都是 单独负责执行服务。