Core C will be responsible for providing administrative and biostatistics support for the overallprogram. It will also serve to amalgamate the investigators, their experimental findings and theirideas, evaluation of clinical efforts and direct the efforts toward enhancing the clinical outcome. Dr.Carl June is Principal Investigator for the Core, and he will be responsible for overall coordination ofscientific direction and clinical progress of the IPCP. Core C will interact with Program managementat NIAID and with the external SAB, coordinating meetings and progress reports. Budget reports,and annual reports to NIH and FDA will be coordinated by Core C. Dr. Kathleen Propert is the Co-Core Leader for Core C and she will direct biostatistics support for the program. Core C will providecomprehensive biostatistics support for the basic science projects and for the clinical trial designand implementation. Therefore, the specific aims are:
Specific aim 1. To coordinate the interactions among scientists and NIH personnel regardingefficient implementation of proposed plans and projects;
Specific aim 2. To oversee all budgetary matters, including monitoring of monthly expenses andpreparation of non-competitive renewal applications;
Specific aim 3. To maintain final records of the FDA pre-clinical and clinical documents andcoordinate all applications/continuations required by other regulatory agencies and committees.
Specific aim 4. To provide statistical support for projects and the clinical trials, bioinformaticssupport for project 2, and to implement the plans to promote data sharing for all projects andcores.
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