Core A will be responsible for providing administrative and biostatistics support for the overall program. The Core will interact with Program management at NIAID and with the external Scientific Advisory Panel, coordinating meetings and progress reports. Budget reports and annual reports to NIH and FDA will be coordinated by Core A. It will also serve to amalgamate the investigators, their experimental findings and their ideas, evaluation of clinical efforts and direct the efforts toward enhancing the clinical outcome. Dr. C. June is Principal Investigator for the Core, and he will be responsible for coordination of scientific direction and will preserve time-lines essential to productivity to assure overall clinical progress of the IPCP. Dr. G. Binder will coordinate clinical operations and is responsible for interactions with private sector partners. She will also oversee all budgetary interactions with investigators. Mrs. Veloso will coordinate regulatory correspondence with federal and local authorities. Core A will provide comprehensive biostatistics support for the basic science projects and for the design and implementation of the clinical trials. Therefore, the specific aims are: ? Specific aim 1. To coordinate the interactions among scientists, private sector partners and NIH personnel regarding efficient implementation of proposed plans and projects. ? Specific aim 2. To oversee all budgetary matters, including monitoring of monthly expenses and preparation of non-competitive renewal applications. ? Specific aim 3. To maintain final records of the pre-clinical and clinical documents required by FDA and coordinate all applications/continuations to meet requirements of other regulatory agencies and committees. ? Specific aim 4. To provide statistical support for projects and the clinical trials, bioinformatics support for Project 2, and to implement the plans to promote data sharing for all projects and cores.
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