Adminitration and Safety Monitoring Core

行政和安全监测核心将支持必要的职能，以确保 三个研究项目和六个核心的成功实施和科学整合，并 为三个SPOTRIAS项目提供独立的内部安全监测：核心活动 将包括：(1)协调SPOTRIAS项目的所有活动，包括实验活动， 执行委员会的会议和活动；(2)向南太地科委调查人员提供协助 编写进度报告，采购设备和用品，并监测财务状况 支出；(3)与华盛顿大学的有关行政机构保持密切联系， 包括参与的科室负责人(急诊内科、神经科、放射科和神经科 (外科)、人类研究委员会、放射性药物研究委员会和礼品办公室 和补助金；(4)与国家神经疾病和中风研究所(NINDS)的工作人员密切互动 并负责财务、进度、数据安全和监控的准备工作 委员会的报告；及(5)为三个项目提供独立的内部安全监察及 与SPOTRIAS数据安全和监控委员会直接沟通。科林·P·德尔迪恩医学博士 将担任行政核心主任。他将监督行政管理的财务方面 SPOTRIAS项目。他将监督向NINDS提交年度进展报告的准备工作。他会的 监督项目和核心项目的财务支持。他将组织和主持每两个月举行一次的 SPOTRIAS内部工作组。这些会议将作为一个小组论坛，监测 岩芯的项目和性能。小罗伯特·格拉布，医学博士，将担任内部安全监控员 为了这些项目。这些项目的主要调查人员将负责向格拉布博士提供所有 他履行这一职责所需的信息。所有重大不良事件都将 向格拉布医生汇报。我们期待美国国家卫生研究院任命一个数据安全和监测委员会(DSMB)，以 项目2和格拉布博士将直接向委员会报告，以及劳伦斯·韦克斯勒，医学博士， 外部安全监控器。格拉布博士还将担任项目2的终点评审员。他将拥有 未经首席调查员同意而暂停任何工程项目的权力

The administrative and safety monitoring core will support those functions necessary to ensure the successful performance and scientific integration of the three research projects and the six cores, and to provide independent internal safety monitoring of the three SPOTRIAS projects: The activities of the core will include: (1) coordination of all activities of the SPOTRIAS project including experimental activities, conferences, and acitivities of the Executive committee; (2) to provide assistance to SPOTRIAS investigators with preparation of progress reports, purchasing equipment and supplies, and monitoring financial expenditures; (3) to maintain close liaison with appropriate administrative bodies at Washington University, including heads of participating Departments (Emergency Medicine, Neurology, Radiology, and Neurological Surgery), the Human Studies Committee, the Radioactive Drug Research Committee, and the office of Gifts and Grants; (4) to interact closely with National Institute of Neurological Disorders and Stroke (NINDS) staff and assume responsibility for the preparation of financial, progress, and data safety and monitoring committee reports; and (5) to provide independent internal safety monitoring of the three projects and communicate directly with the SPOTRIAS data safety and monitoring committee. Colin P. Derdeyn, M.D., will serve as Director of the Administrative core. He will oversee the financial aspects of the administration of the SPOTRIAS project. He will supervise preparation of annual progress reports to the NINDS. He will supervise the financial support of the projects and cores. He will organize and chair bimonthly meetings of the internal SPOTRIAS working group. These meetings will serve as a group forum to monitor progress of the projects and performance of the cores. Robert Grubb, Jr.,, M.D., will serve as an internal safety monitor for the projects. The principal investigators of the projects will be responsible for providing Dr. Grubb with all the necessary information for him to execute this responsibility. All significant adverse events will be reported to Dr. Grubb. We expect the NIH to appoint a data safety and monitoring committee (DSMB) for Project 2 and Dr. Grubb will report directly to this committee, as well as Lawrence Wechsler, M.D., the external safety monitor. Dr. Grubb will also serve as the end-point adjudicator for project 2. He will have the authority to suspend any project without the consent of the principal investigator