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 该核心将由威尔逊博士与Drs执导。 Rader和Caplan担任联合导演。核心 将提供基本的行政支持来管理计划项目的财务运营 包括对帐户的监督，采购以及向机构报告和提交报告， 以及NIH。将召集外部科学咨询委员会（ESAC），这将 包括科学家了解与赠款相关领域的知识渊博，包括免疫学，血脂异常， AAV和矢量安全评估。道德咨询委员会（EAB）也将召集和主持 由Caplan博士。该董事会将包括来自ESAC的科学家，以及 继承的疾病和具有道德，政策和法律专业知识的人。 ESAC和EABWILL会议 每年审查科学的进步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的目标细胞群，知情同意，包含和排除标准， 主题招募和与社区的沟通。核心还将提供支持 生物统计学。 Joy Cavagnaro博士将担任有关FDA相关问题的顾问。 外行描述。该核心将为实施程序提供所有行政支持。 外部科学咨询委员会和道德咨询委员会都将召集。 相关性（请参阅说明）：