Adminitration and Safety Monitoring Core

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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