Administrative Core

项目总结

PROJECT SUMMARY The Administrative Core is responsible for the operations, communications, regulatory and financial oversight of the program, as well as supervision of the conduct of the proposed grant. The program is highly integrated and the preclinical and scientific studies impact directly on development of the translational clinical research protocols. The Administrative Core supervises the operations of the program and facilitates reports, communication between investigators and visits of our internal and external advisors as well as outside investigators. Clinical trials for this PO1 are only conducted at the two lead institutions, MD Anderson Cancer Center (MDACC) under the leadership of Dr. Elizabeth Shpall and Children's National Health System (CNHS) under the leadership of Dr. Catherine Bollard. Pre-clinical studies will be performed at the other three PO1 institutions in conjunction with the PO1 Project leaders including Harvard University (Project 1-Dr. Robert Sackstein and Dr. Shpall), George Washington University (Project 2- Dr. Douglas Nixon and Dr. Bollard) and Baylor College of Medicine (BCM) (Project 3- Dr Jordan Orange and Dr. Katy Rezvani). The two Core A leaders, Drs. Shpall and Bollard have been working together closely since 2004. They have developed a sustained and in depth collaboration, which began when Dr Bollard was at BCM and was transferred seamlessly to CNHS when she was recruited there in 2012. The core supports the Institutional Review Board (IRB), Food and Drug Administration (FDA) Investigational New Drug (IND), Investigational Biosafety Committee (IBC), and National Institutes of Health Office of Biotechnology Activities Recombinant DNA Committee (NIH/OBA/RAC) submissions and reporting required for clinical protocols in the P01. The core manages program personnel, accounts and budgets for each section of the grant, including ongoing reports of account balances for the investigators. The core is responsible for preparing the necessary reports to the funding agency, for the research projects and publications. This shared resource core is an essential and critical part of this PO1. The proposed services will facilitate the communication between the investigators and our advisors; facilitate the translation of the pre-clinical projects to the clinic by procuring all the requisite IND and RAC approvals in addition to providing on-going reports to the agencies, and will provide CB units to all four projects as well as Cores C to accomplish the proposed goals and objectives of the PO1. Centralizing these functions assures maximal efficiency, integration, consistency and oversight, which would not be possible if each Project and Core were individually responsible for performing the services.