Administrative Core

行政核心

• 批准号: 7595335
• 负责人: James M Wilson
• 金额: $ 11.61万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7595335
• 关键词: Accounting; Address; Advisory Committees; Area; Biometry; Cardiovascular Diseases; Cells; Child; Clinical Trials; Communication; Communities; DNA Viruses; Disease; Dyslipidemias; Ethics; Exclusion Criteria; Grant; Immunology; Informed Consent; Inherited; Institution; Instruction; Laws; Operative Surgical Procedures; Parents; Policies; Population; Preparation; Reporting; Safety; Science; Scientist; United States National Institutes of Health; adeno-associated viral vector; base; clinical application; gene therapy; programs; vector

j Core D - Administrative Core This core will be directed by Dr. Wilson with Drs. Rader and Caplan serving as co-directors. The core will provide basic administrative support to manage the financial operations of the program project to include oversight of accounts, purchasing, and preparation and submission of reports to the institution, as well as to the NIH. An External Scientific Advisory Committee (ESAC) will be convened, which will include scientists knowledgeable about areas relevant to the grant including immunology, dyslipidemias, AAV and vector safety assessment. An Ethics Advisory Board (EAB) will also be convened and chaired by Dr. Caplan. This Board will include a scientist from the ESAC, as well as parents of children with inherited diseases and people with expertise in ethics, policy, and law. The ESAC and EABwill convene on an annual basis to review the progress of the science and help the team address important issues related to the ultimate clinical applications of gene therapy. Issues that will be considered by the EAB include target cell populations for early clinical trials, informed consent, inclusion and exclusion criteria, subject recruitment and communication with the community. The Core will also provide support in biostatistics. Dr. Joy Cavagnaro will serve as a consultant regarding FDA-related issues. Lay description. This Core will provide all administrative support for the implementation of the program. Both an External Scientific Advisory Committee and an Ethics Advisory Board will be convened. RELEVANCE (See instructions):

j 核心 D - 行政核心 该核心将由 Wilson 博士和 Drs 指导。雷德和卡普兰担任联合导演。核心 将提供基本的行政支持来管理该计划项目的财务运作 包括监督账户、采购、准备和向机构提交报告， 以及美国国立卫生研究院 (NIH)。将召集外部科学咨询委员会（ESAC），该委员会将 包括熟悉与资助相关领域的科学家，包括免疫学、血脂异常、 AAV 和载体安全评估。道德咨询委员会（EAB）也将被召集并担任主席 由卡普兰博士撰写。该委员会将包括一名来自 ESAC 的科学家，以及患有此类疾病的儿童的家长。 遗传性疾病和具有伦理、政策和法律专业知识的人。 ESAC 和 EAB 将召开会议 每年回顾科学进展并帮助团队解决重要问题 关系到基因治疗的最终临床应用。 EAB将考虑的问题 包括早期临床试验的靶细胞群、知情同意、纳入和排除标准， 受试者招募以及与社区的沟通。核心还将提供支持 生物统计学。 Joy Cavagnaro 博士将担任 FDA 相关问题的顾问。 平铺说明。该核心将为该计划的实施提供所有行政支持。 将召集外部科学咨询委员会和道德咨询委员会。 相关性（参见说明）：