National Islet Cell Consortium Coordinating Center

该提案旨在建立胰岛细胞资源（ICR）管理和生物信息协调中心 （ABCC）在希望之城国家医疗中心的信息科学部。我们将提供 在多中心研究协调、生物医学信息学和生物统计学方面的专业知识和经验， 通过实现以下具体目标来实现工业和企业代表项目的目标：1）履行行政职能 协调最好放在一个普遍可访问的单一核心中的国际民事代表活动。（二） 为ICR指导委员会和信息标准小组提供行政支持和监督， 以马克思3)通过协调胰岛细胞分布，相互作用， 与国家胰岛/β细胞登记处密切合作，以有效交换数据和促进细胞 分布4)容纳建立和维护统一的中央信息系统所需的核心信息资源， 数据库，使用创新的领先技术和安全/保密做法，以及5）收集，管理， 并分析来自胰岛细胞处理和ICR临床试验的数据，以优化胰岛细胞分离， 人类胰岛细胞移植的安全性和有效性。项目方向将由以下人员领导的小组提供： ABCC主任兼首席研究员Joyce Niland博士，包括联合主任大卫Ik 16博士， 生物统计学和生物医学信息学联合主任道格拉斯斯塔尔博士。这些调查人员有广泛的 具有管理生物统计学、临床试验管理和生物医学信息学资源的经验， 支持多中心临床试验和基础科学研究。此外，他们将利用技术， 临床试验数据管理是在完全集成的研究标准和技术下开发的 （FIRST）由NCRR资助的倡议，为十个胰岛细胞资源（ICR）提供必要的信息资源 参与该项目的中心。ABCC将与NCRR和指导委员会密切合作， 旨在确保安全有效地开发最佳胰岛细胞的合作协议 在每个ICR使用cGMP合规设施，与当地、区域和 国家器官采购组织和移植登记处。除了提供行政支持外， 和信息基础设施，ABCC将监测ICR的cGMP和cGMP合规性，并将提供 临床试验设计和统计分析方面的专业知识，以促进临床试验的开发和分析 在中央数据库中汇总数据，以优化胰岛细胞移植结果。

This proposal is to establish the Islet Cell Resources (ICR) Administrative and BioinformaUcs Coordinating Center (ABCC) within the Division of Information Sciences at City of Hope National Medical Center. We will provide expertise and experience in multi-center study coordination, biomedical informatics, and biostatistics to support the ICR project objectives by carrying out the following specific aims: 1) serving the administrative functions common to the ICRs and coordinating ICR activities that are best housed in a generally accessible single core. 2) providing administrative support and oversight to the ICR Steering Committee and an Information Standards Sub- Committee. 3) promoting translational research through the coordination of islet cell distribution, interacting closely with the National Islet/Beta Cell Registry for the efficient exchange of data and facilitation of cell distribution. 4) housing the core informatics resources required to create and maintain the consolidated central database, using innovative leading technology and security/confidentiality practices, and 5) collecting, managing, and analyzing data from the processing of islet cells and from ICR clinical trials, to optimize islet cell isolation and the safety and efficacy of islet cell transplants in humans. Project direction will be provided by a team led by ABCC Director and Principal Investigator Dr. Joyce Niland, and including Dr. David Ik16, Co-Director for Biostatistics, and Dr, Douglas Stahl, Co-Director for Biomedical Informatics. These investigators have extensive experience managing biostatistics, clinical trials management and biomedical informatics resources required to support multi-center clinical trials and basic science investigations. In addition, they will leverage technology for clinical trials data management being developed under the Fully Integrated Research Standards and Technology (FIRST) initiative funded by NCRR to provide essential informatics resources to the ten Islet Cell Resource (ICR) centers participating in this project. The ABCC will work closely with the NCRR and the Steering Committee under a cooperative agreement designed to ensure the safe and efficient development of optimal islet cell transplantation strategies using cGMP compliant facilities at each ICR in collaboration with local, regioinal and national organ procurement organizations and transplant registries. In addition to providing administrative support and informatics infrastruscture, the ABCC will monitor ICRs for cGMP and cGLP compliance and will provide expertise in clinical trial design and statistical analysis to facilitate development of clinical trials and to analyze pooled data in the central database to optimize islet cell transplant outcomes.