Administrative Core

行政核心

• 批准号: 10247037
• 负责人: Elizabeth J Shpall
• 金额: $ 19.04万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247037
• 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.

项目摘要 行政核心负责业务、通信、监管和 对该计划进行财务监督，并监督拟议赠款的执行情况。 该计划是高度集成的，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，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人员的访问。临床试验 PO 1仅在两个牵头机构MD安德森癌症中心（MDACC）进行 在伊丽莎白·什帕尔博士和儿童国家卫生系统（CNHS）的领导下， 在凯瑟琳·博拉德博士的领导下。临床前研究将在另一个 三个PO 1机构与PO 1项目领导人（包括哈佛大学）合作 （项目1-罗伯特·萨克斯坦博士和什帕尔博士），乔治华盛顿大学（项目2-博士。 道格拉斯尼克松和博士博拉德）和贝勒医学院（北）（项目3-博士乔丹 橙子和凯蒂雷兹瓦尼博士）。核心A的两位领导人，Shpall博士和Bollard博士， 自2004年以来一直密切合作。他们发展了一种持续深入的 这种合作始于波拉德博士在斯坦福大学的时候，后来无缝地转移到了 2012年，她在CNHS被招募。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 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 重组DNA委员会（NIH/OBA/RAC）提交和报告临床 P01中的协议。核心管理每个项目的人员、账户和预算。 调查员还将收到赠款部分的报告，包括不断向调查员报告账户余额。的 核心委员会负责为研究编写必要的报告，提交给资助机构， 项目和出版物。此共享资源核心是此PO 1的基本和关键部分。 建议的服务将有助调查人员与我们的 顾问;通过采购所有 除了向监管机构提供持续报告外，还必须获得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 和PO 1的目标。集中这些职能可确保最大的效率、整合， 一致性和监督，如果每个项目和核心都 个人负责提供服务。