ADMINISTRATIVE

Duke University, Durham NC

Investigators

Linked publications, trials & patents

Abstract

The objectives of the Administrative Core are to provide four sources of support for the program members: (1) fiscal management, (2) staff specialist services, (3) facilitate communication, and (4) serve as coordination point and communication center for the FDA and the coordination mechanism for scheduling and running 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 of the 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 related scientific meetings and conferences, organizing group meetings and seminars, and organization of the quarterly dinner meetings and the annual research retreat. This service will also maintain current biosketches and facilities statements for all program directors.. Specific Aim 3 - Facilitate Inter-program communication. Minutes are taken at all program meetings, which include ACTION ITEMS that are tracked until completed. All communications are posted at a members only website (password protected) as well as being distributed by email. Other important documents, such as protocols, DSMB reports, case report forms, blank informed consent forms and project related data will be kept on the website for easy access by all program participants. Specific Aim 4 - Serve as the central coordination point for communications with the FDA. The program currently has three IDEs supporting ongoing clinical trials. There will be additional IDEs filed during the next funding cycle. The Administrative Core will handle all correspondence with the FDA and will coordinate the preparation of new applications and reports, using input from the appropriate program directors offices. This core will also organize the DSMB meetings, in collaboration with Core 2. The reports from the DSMB will be distributed to program members and posted on the secure website for future reference.