Clinical and Statistical Core

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ABSTRACT The Clinical and Statistical Core for the University of Washington (UW) STI CRC is located in dedicated clinical research space on the 11th floor of a newly constructed building on the UW-Harborview Medical Center campus, the Infectious Diseases Research Clinic. The research clinicians and coordinators who work at the Research Clinic have many years of experience in STI-related research, and there is close collaboration with the STD clinic. Our aims are: The Clinical and Statistical Core will recruit, evaluate and retain participants to provide clinical specimens for study in Project 3, and provide data management, power calculations and analysis for experiments generated in Projects 1, 2 and 3. In addition, this Core will work closely with the Genomics and Isolation Core to complete sequencing analyses. These teams have a history of working together in previous studies of pathogen sequencing, jointly managing specimen tracking and data storage. The bioinformatic pipeline of the Genomics and Isolation Core will provide the Clinical and Statistical Core with assembled, aligned, annotated sequences for further analyses. The Clinical and Statistical Core also ensures the integrity of data collected for all Projects by adhering to study procedures and promoting the highest standards of human subjects research, including adherence to Good Clinical Practices. The Core also ascertains that the study design and analytical techniques are optimized to permit the most robust experiments and interpretation of the results. Rigor is based on careful preparation of analysis plans, adherence to such plans, and transparency in reporting the conducted analyses.