Administration and Clinical Trial Coordination

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The Administration and Clinical Trial Coordination Core A will serve as the central organizational hub of the Program. This Core will have 5 main functions: 1) To coordinate the administrative and fiscal management of the Program Project; 2) To provide research coordination and review through meetings of internal program members and external consultants; 3) To provide support for all of the clinical trials by providing consistency in IRB interactions, severe adverse event reporting, clinical grading of graft vs host disease and regulatory expertise; 4) To coordinate follow-up of patients who have undergone transplantation on clinical trials of this PPG; 5) To ensure access of both genders and all minorities to clinical trials. The Core will provide oversight and fiscal management to the Project and coordinate these efforts through dedicated personnel with expertise in these defined areas. Since many of the clinical trials require FDA oversight through INDs central coordination of this effort through organization of the INDs, communication with the FDA and reporting of outcomes to institutional and external regulatory bodies will be a critical role for the Core. Centralizing this effort will provide expertise and consistency in these efforts. The Core will organize and facilitate a panel of external consultants who will visit the Program yearly and provide critique and guidance. A monthly Program Project meeting will also be organized by the Core. The Core leader will liaison with Divisional, Departmental and Cancer Center personnel to enhance interactions and facilitate discoveries. All of the Projects and Cores will utilize Core A functions.