Rho Federal Systems Division, Inc. NIAID DAIT SACCC

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This project is a one-year extension of the consolidated DAIT Statistical and Clinical Coordinating Center (DAIT SACCC). The extension will enable crucial continuity of services while the individual successor contracts assuming the work of the DAIT SACCC are awarded and any necessary transitions occur. The DAIT SACCC supports research in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation. The objective of the DAIT SACCC is to provide efficient coordination of the following services: protocol development, study initiation and management, statistical design and analysis, clinical site monitoring, ancillary services, data management, and safety oversight. During the extension, the DAIT SACCC will continue to (1) provide staff experienced in research conducted by DAIT-supported consortia and organize these staff in an administrative structure that manages resources efficiently, is responsive to the needs of the research consortia and DAIT, and facilitates communication and collaboration; (2) provide experienced scientists and statisticians who, in collaboration with clinical investigators and DAIT officials, design and analyze studies across the full scope of research; (3) facilitate the development, review, and revision of protocols and protocol-related documents through dedicated protocol teams; (4) provide study initiation and study management functions required for the efficient, valid, and ethical conduct of studies; (5) provide well-developed procedures and personnel for the monitoring of clinical sites; (6) provide efficient and accurate tracking and reconciliation of specimen collection and distribution; (7) provide integrated and secure information management systems and procedures for the collection of clinical and mechanistic data; (8) help ensure patient safety by providing high-quality serious adverse event (SAE) reporting and Data and Safety Monitoring Board (DSMB) reports; and (9) provide tools, infrastructure, and analytical support in the planning, implementation, analysis, and dissemination of high dimensional mechanistic studies.