Administrative Core

J 核心D-管理核心 这个核心将由威尔逊博士执导，雷德和卡普兰博士担任联合导演。其核心是 将提供基本的行政支持，以管理计划项目的财务运营 包括监督账目、采购、准备和向该机构提交报告， 以及美国国立卫生研究院。将召集一个外部科学咨询委员会(ESAC)，该委员会将 包括对与拨款相关的领域有了解的科学家，包括免疫学、血脂异常、 AAV和病媒安全评估。道德咨询委员会(EAB)也将召开会议并担任主席 卡普兰医生写的。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、政策和法律专业知识的人。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 关系到基因治疗的最终临床应用。选管会将会考虑的事项 包括早期临床试验目标细胞群体、知情同意、纳入和排除标准， 科目招募和与社区的沟通。核心还将在以下方面提供支持 生物统计学。喜悦·卡瓦纳罗博士将担任美国食品和药物管理局相关问题的顾问。 版面描述。该核心将为该方案的实施提供所有行政支持。 将召集一个外部科学咨询委员会和一个道德操守咨询委员会。 相关性(请参阅说明)：

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):