PROJECT SUMMARY/ABSTRACT—OVERALL COMPONENT Through this Funding Opportunity Announcement, the NIAID Division of Allergy, Immunology and Transplantation (DAIT) intends to consolidate its funding for multiple, independent Statistical and Clinical Coordinating Centers (SACCCs) into a single multi-component cooperative agreement, presumably to reduce costs and increase efficiency and standardization across research consortia. This new program will fund a single SACCC, or Center, to support DAIT research in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation. Because Rho is currently the SACCC for many of these consortia and these SACCCs already share some resources and processes, Rho is well suited to provide consolidated support. The objective of the Center is to provide excellent and efficient coordination of the following services: protocol development, study initiation and management, statistical design and analysis, clinical site monitoring, ancillary services, data management, safety oversight, and bioinformatics. To accomplish these objectives, Rho aims to (1) provide staff experienced in research conducted by DAIT-supported consortia and to 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 initial and successive drafts of 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) provide high-quality and well-developed procedures and personnel for the monitoring of clinical sites; (6) provide the efficient and accurate tracking and reconciliation of specimen collection and distribution; (7) provide high-quality, 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. Based on our substantial experience coordinating all aspects of clinical research, we plan to 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 Center staffing and resource sharing; standardize processes and methodologies across disease groups and centralized groups; and continue to provide the flexibility necessity to meet the changing demands of this dynamic research program.

PROJECT NARRATIVE—OVERALL COMPONENT This cooperative agreement funds a coordinating center that provides investigators with the tools, expertise, and support to conduct effective clinical research studies in the areas of allergy, immunology, and transplantation. The tools, expertise, and support include the design of the studies, the capture of necessary data, the management of all the clinical sites, the oversight of potential safety issues, and the analysis of the data providing results. By helping investigators complete successful studies, we will have a better understanding of the mechanisms of these disease areas and improved health for patients.