RhoFED AA-SCCC

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PROJECT SUMMARY/ABSTRACT The cooperative agreement funded by this Funding Opportunity Announcement establishes an Asthma and Allergy Statistical and Clinical Coordinating Center (AA-SCCC), which will further NIAID’s mission to support clinical research aimed at developing new or improved strategies to treat or prevent allergic diseases and asthma. The objective of the AA-SCCC is to provide excellent and efficient coordination of the following services: protocol development, study initiation and management, statistical design and analysis, and biological specimen repository management. To accomplish these objectives, Rho aims to (1) provide staff experienced in research conducted by NIAID-supported research networks and to organize these staff in an administrative structure that manages resources efficiently, is responsive to the needs of the research networks and NIAID, and facilitates communication and collaboration; (2) provide experienced scientists and statisticians who, in collaboration with clinical investigators and NIAID officials, design and analyze studies across the full scope of research; (3) facilitate the development, review, and revision of research protocols and protocol-related documents through dedicated protocol teams; (4) provide study initiation and study management functions that are required for the efficient, valid, and ethical conduct of studies; (5) continuously monitor the accuracy and completeness of research data; (6) help ensure patient safety by providing high- quality adverse event surveillance and Data and Safety Monitoring Board (DSMB) reports; (7) provide for secure storage of biospecimens, along with their distribution for innovative mechanistic research; and (8) effectively collaborate with the other components of the NIAID clinical research program, e.g. the NIAID Regulatory Management Center (RMC), the Clinical Data and Safety Management Center (CDSMC), the Clinical Site Monitoring Center (CSMC), and the Clinical Products Center (CPC). Based on more than 25 years of experience coordinating all aspects of clinical research in asthma and allergic diseases, we will use our current technology infrastructure, combined with new and innovative techniques to: streamline and automate processes; provide easy access to data for DAIT, clinical investigators, and other key research stakeholders; allow for flexibility of staffing and resource sharing; standardize processes and methodologies across research networks where practicable; and continue to provide the flexibility necessity to meet the changing demands of this dynamic research program.