The Clinical, Laboratory and Data Management Core (Core B) establishes infrastructure to collect, store and disseminate clinical and laboratory data as well as specimens from subjects in support ofthe scientific aims proposed in Projects 1, 2 and 3. It is physically located and coordinated at Northwestern University (NU) and serves as a primary site for the recruitment of well-characterized tertiary-care patients with CRS. Core B will provide oversight of data and specimen consistency and serve as the nexus for the trans-institutional projects proposed. To achieve these aims. Core B will increase the resolution of clinical characterization of CRS patients at NU and provide a mechanism for tracking longitudinal outcomes to enhance the clinical impact of findings in Project 2 and Project 3. To ensure consistency of sample acquisition in Project 1 and Project 2, the core will conduct training for relevant personnel and provide a platform for sharing of protocols for sample acquisition. Core B also provides a resource that pilots and optimizes protocols for generating microbial-stimulated specimens for P2 and P3. Finally, it provides the information technology infrastructure for HlPAA-compliant clinical data collection, specimen tracking and data dissemination for all three projects. The Core Director, Robert Kern, MD, is the Chairman of Otolaryngology at NU, with extensive administrative and clinical experience. Other key personnel include Atsushi Kato, PhD (Co-I), who is the leader ofthe laboratory portion ofthe core. Dr. Kato has extensive experience in immunology research, and CRS research in particular. Bruce Tan, MD (Co-I) is a physician scientist with clinical expertise in sinonasal disorders and laboratory experience in molecular and cell biology. Dr. Tan, a current K23 grant recipient, has interest and experience in the epidemiology of CRS and data management and in information technology as applied to clinical research. Additionally, Core B leverages institutional expertise available at NU through the Bioinformatics Center (NUBIC) under Warren Kibbe, PhD;the biostatistics collaboration center (BCC) under Alfred Rademaker, PhD;and the Feinberg School of Medicine (FSM) information systems directorate under Frank Schleicher.
Core B provides physical, laboratory, information technology, and training infrastructure for collection, storage and dissemination of data and biological specimens from subjects with chronic rhinosinusitis and control subjects without disease. It additionally provides clinical and laboratory expertise to ensure consistent definitions, specimen handling and endpoint interpretation.