Clinical and Statistical Core

摘要 华盛顿大学 (UW) STI CRC 的临床和统计核心位于专门的 威斯康星大学港景医疗中心新建建筑 11 楼的临床研究空间 校园，传染病研究诊所。在该中心工作的研究临床医生和协调员 Research Clinic拥有多年STI相关研究经验，并与以下机构有密切合作 性病诊所。我们的目标是： 临床和统计核心将招募、评估和保留参与者 为项目3的研究提供临床标本，并提供数据管理、功效计算和 对项目 1、2 和 3 中生成的实验进行分析。此外，该核心将与 基因组学和分离核心完成测序分析。这些团队都有工作历史 在之前的病原体测序研究中，共同管理样本跟踪和数据存储。 基因组学和分离核心的生物信息学管道将提供临床和统计核心 具有组装、比对、注释的序列以供进一步分析。 临床和统计核心还通过坚持研究来确保为所有项目收集的数据的完整性 程序并促进人类受试者研究的最高标准，包括遵守良好标准 临床实践。核心还确定研究设计和分析技术经过优化，以 允许最可靠的实验和结果解释。严谨性是建立在精心准备的基础上的 分析计划、遵守此类计划以及报告所进行的分析的透明度。

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.