Administrative and Clinical Research Support Core

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The Administration and Clinical Research Support Core will provide essential support for all administrative activities and clinical trials associated with the program project grant. The extensive early phase clinical trial activities in Projects 1-3 within this renewal application has required expanded activities undertaken by the Core. The administrative components of the Core will provide support for accounting, budgeting, fiscal reporting, and communication, while the clinical research support components will facilitate protocol activation and execution, effective dissemination of information between Projects and Core B (biostatistics) and Core C (Immune Monitoring & Tissue Analysis). Clinical research support activities will include preparation and distribution of protocol revisions, research sample calendar monitoring, collection, tracking, and distribution to research laboratory sites, as well as monitoring supply procurement and distribution for centrally purchased materials needed for clinical trials. Core A personnel will also assure appropriate preparation and timely submission of protocols for review as needed by the University of Minnesota Institutional Review Board (IRB), Cancer Center Protocol Review Committee, the Food and Drug Administration, and the National Marrow Donor Program (NMDP) IRB. Core personnel will provide all necessary information for the other clinical site investigators to be prepared for submission to their own Institutional Review Board and other internal and external regulatory bodies. In the upcoming funding period, Core A will also assume more direct involvement in insuring quality performance of required protocol activities for the proposed trials in Projects 1-3. Core responsibilities will include protocol monitoring and communication among project and core personnel through in-person meetings, regularly scheduled conference calls, and additional telephone communication. Additionally, the Core will support scheduling and coordination of internal research meetings and external consultant visits. Finally, Core A will carry on the established accomplishments of the current funding in NK cell immunogenetics. Core personnel will coordinate KIR/HLA typing of NK cell products through the NMDP and curation of new KIR alleles and large transplant cohort analyses by Project investigators including the screening of third party CMV+ donors for adaptive NK cell studies. This broadly collaborative resource in immunogenetic analysis of HCT outcomes will be used to assess the impact of KIR/HLA interactions on NK cell biology, clinical outcomes, and design off-the- shelf NK cell products. This Core will be led by Dr. Jeffrey Miller who will work directly with his Executive Committee and External Advisory Board to coordinate their involvement within this Program. The Specific Aims of the Core are to provide administrative support, scientific oversight, clinical oversight/services, coordination of HLA/KIR typing and analysis, and leadership and resources to promote PPG interactions and collaborations.