The objectives of the Administrative Core are to provide four sources of support for the programmembers: (1) fiscal management, (2) staff specialist services, (3) facilitate communication, and (4) serve ascoordination point and communication center for the FDA and the coordination mechanism for scheduling andrunning data safety and monitoring board (DSMB) meetings. The core has the following specific aims:
Specific Aim 1 - Manage Fiscal Affairs. The core will provide up-to-the-date support for the fiscal affairs ofthe program. This includes personnel management of other support, setting up and monitoring fund codes,providing monthly balance sheets to program project directors and managing travel reimbursements.
Specific Aim 2 - Provide staff specialist services. The services include arranging for travel to grant relatedscientific meetings and conferences, organizing group meetings and seminars, and organization of thequarterly dinner meetings and the annual research retreat. This service will also maintain current biosketchesand facilities statements for all program directors..
Specific Aim 3 - Facilitate Inter-program communication. Minutes are taken at all program meetings, whichinclude ACTION ITEMS that are tracked until completed. All communications are posted at a members onlywebsite (password protected) as well as being distributed by email. Other important documents, such asprotocols, DSMB reports, case report forms, blank informed consent forms and project related data will be kepton the website for easy access by all program participants.
Specific Aim 4 - Serve as the central coordination point for communications with the FDA. The programcurrently has three IDEs supporting ongoing clinical trials. There will be additional IDEs filed during the nextfunding cycle. The Administrative Core will handle all correspondence with the FDA and will coordinate thepreparation of new applications and reports, using input from the appropriate program directors offices. Thiscore will also organize the DSMB meetings, in collaboration with Core 2. The reports from the DSMB will bedistributed to program members and posted on the secure website for future reference.
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