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 这个核心将由威尔逊博士指导，雷德博士和卡普兰博士担任联合主任。核心 将提供基本的行政支持，以管理该计划项目的财务运作， 包括监督账户、采购以及编写和向该机构提交报告， 以及国家卫生研究院将召集一个外部科学咨询委员会（ESAC）， 包括科学家了解有关领域的赠款，包括免疫学，血脂异常， AAV和载体安全性评估。还将召集和主持道德操守咨询委员会 卡普兰博士。该委员会将包括一名来自ESAC的科学家，以及患有 遗传性疾病和具有伦理、政策和法律方面专门知识的人。ESAC和EAB将召开 每年审查科学进展，并帮助团队解决重要问题 与基因治疗的最终临床应用有关。EAB将考虑的问题 包括用于早期临床试验靶细胞群、知情同意、纳入和排除标准， 受试者招募和与社区的沟通。核心还将在以下方面提供支助： 生物统计学Joy Cavagnaro博士将担任FDA相关问题的顾问。 Lay描述。该核心将为方案的实施提供所有行政支持。 将召集外部科学咨询委员会和伦理咨询委员会。 相关性（参见说明）：