Clinical, Laboratory, and Data Management Core

摘要： 项目摘要(见说明)：临床、实验室和数据管理核心(核心B)建立基础设施，以收集、存储和传播临床和实验室数据以及来自受试者的样本，以支持项目1、2和3提出的科学目标。它位于西北大学(NU)并进行协调，是招募特征良好的三级CRS患者的主要地点。核心B将监督数据和样本的一致性，并作为拟议的跨机构项目的纽带。来实现这些目标。CORE B将提高NU CRS患者临床特征的分辨率，并提供纵向结果跟踪机制，以增强项目2和项目3中发现的临床影响。为确保项目1和项目2中样本采集的一致性，核心将对相关人员进行培训，并提供共享样本采集协议的平台。核心B还提供了一个资源，用于试验和优化为P2和P3生成微生物刺激样本的方案。最后，它为所有三个项目提供符合HlPAA标准的临床数据收集、样本跟踪和数据传播的信息技术基础设施。核心主任罗伯特·科恩医学博士是国立大学耳鼻喉科的主席，具有丰富的行政和临床经验。其他关键人员包括加藤敦博士(Co-I)，他是核心实验室部分的负责人。加藤博士在免疫学研究，特别是CRS研究方面拥有丰富的经验。布鲁斯·谭，医学博士(Co-I)，是一位内科科学家，在鼻窦疾病方面具有临床专长，并在分子和细胞生物学方面具有实验室经验。陈博士目前是K23赠款获得者，他对CRS的流行病学和数据管理以及临床研究中应用的信息技术有兴趣和经验。此外，Core B通过Warren Kibbe博士领导的生物信息学中心(NUBIC)、Alfred Rademaker博士领导的生物统计合作中心(BCC)以及Frank Schleicher领导的范伯格医学院(FSM)信息系统董事会，利用NU现有的机构专业知识。

ABSTRACT: PROJECT SUMMARY (See instructions): 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 of the 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 of the laboratory portion of the 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.