This contract supports the Statistical and Clinical Coordinating Center for two major Division research programs: the Collaborative Network for Clinical Research on Immune Tolerance and the Autoimmunity Centers of Excellence. Specifically, this contract will provide the statistical, clinical, regulatory, technical and administrative expertise necessary to support clinical trials and mechanistic studies of tolerogenic and immunomodulatory approaches for the treatment of multiple immune system diseases, including: (1) statistical leadership in the design, implementation and analysis of clinical trials and studies of underlying mechanisms; (2) establishment and administration of systems for the collection, storage, management, quality assurance and reporting of study data; (3) clinical site monitoring and training; (4) regulatory and technical functions and requirements associated with Investigational New Drug Applications (INDs); (5) coordination of activities of an independent Data and Safety Monitoring Board (DSMB); and (6) receipt, storage and distribution of study products.
