Clinical and Statistical Core

临床和统计核心

• 批准号: 10461737
• 负责人: Anna Wald
• 金额: $ 9.54万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10461737
• 关键词: Address; Adherence; Bacteria; Bacterial Vaginosis; Biopsy; Clinic; Clinical; Clinical Research; Collaborations; Communication; Complex; County; Data; Data Analyses; Data Storage and Retrieval; Disease; Enrollment; Ensure; Exudate; Floor; Genomics; Good Clinical Practice; Herpesviridae Infections; Human Subject Research; Immune response; Immunologics; Immunology; Immunology procedure; Infection; Infectious Diseases Research; Infectious Skin Diseases; Laboratories; Medical center; Morbidity - disease rate; Mucous Membrane; Natural History; Participant; Pathogenesis; Patients; Preparation; Procedures; Recording of previous events; Reporting; Reproducibility; Research; Research Design; Research Personnel; Sample Size; Services; Sexual Partners; Sexually Transmitted Diseases; Simplexvirus; Site; Skin; Specimen; Statistical Data Interpretation; Syphilis; Syphilitic chancre; Techniques; Treponema pallidum; Universities; Urethritis; Washington; Work; analytical method; base; bioinformatics pipeline; data integrity; data management; experience; experimental study; high standard; human data; human subject; innovation; neonate; novel strategies; pathogen; recruit; syphilis vaccine

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.

摘要 华盛顿大学(UW)STI CRC的临床和统计核心位于专门的 UW-Harborview医疗中心一栋新建建筑的11层临床研究空间 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 研究诊所在性传播感染相关研究方面拥有多年经验，并与 性病诊所。我们的目标是：临床和统计核心将招募、评估和留住参与者 为项目3的研究提供临床标本，并提供数据管理、功率计算和 对项目1、2和3中产生的实验进行分析。此外，该核心将与 基因组学和分离核心，以完成测序分析。这些团队有工作的历史 在以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 以及组装、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 程序和促进人类受试者研究的最高标准，包括坚持良好 临床实践。核心还确保研究设计和分析技术得到优化，以 允许进行最可靠的实验和对结果的解释。严谨是基于精心准备的 分析计划、遵守此类计划以及报告所进行的分析的透明度。