PATIENT RECRUITMENT/DATA MANAGEMENT CORE

核心C：患者招募和数据管理核心(PRDMC)是由 优秀的调查人员、工作人员和物质资源，将为 COPD SCCOR。PRDMC由曾傑瑞·A·克里希南博士领导，他是一名获得董事会认证的肺科医生 在慢性阻塞性肺疾病患者的管理方面具有专业知识并接受过严格培训的医生 流行病学家/临床调查员。Daniel Scharfstein博士，SCD，将担任 PRDMC并指导临床研究的分析，以成功实现拟议的 明确的目标。PRDMC将负责管理招聘和基线 临床研究参与者的特征以及高质量数据的表现 SCCOR的管理和分析功能。参与者招募是最苛刻的要求之一 临床研究的方方面面及其所需的努力和资源经常被低估。我们的 三个临床项目将从COPD患者的共同池中招募。PRDMC将会发挥作用 与特定项目的研究调查人员密切合作，以确保他们拥有准确和详细的 研究结果的文档记录。这一核心将在项目开始时开始运作，并将 协作研究计划，包括研究设计、开发操作手册和数据 收集表格、监测患者招募、数据收集/管理工作和统计 分析。PRDMC将负责协调和制定临床项目的报告 与数据安全和监控、不良事件和招聘监控相关，供 约翰霍普金斯大学IRB和数据安全与监测委员会。此外，PRDMC还将与 项目和其他核心项目的领导和协查人员，以确保 SCCOR的调查结果通过报告、摘要和手稿及时发布。PRDMC， 因此，将有助于高效和成功地完成每个项目和 促进通过各种研究获得的知识的综合。核心将与所有 项目(1-5)和核心B提供统计咨询、招聘和定性。

CORE C: The Patient Recruitment and Data Management Core (PRDMC) is an assemblyof outstanding investigators, staff, and material resourcesthat will provide vital infrastructure support to the COPD SCCOR. The PRDMCis headed by Dr. Jerry A. Krishnan, MD, PhD, a board-certifiedpulmonary physician with expertise in the management of patients with COPD and a rigorously trained epidemiologist/clinical investigator. Dr. Daniel Scharfstein, ScD, will be co-investigator/lead statistician in the PRDMC and direct the analyses of the clinical studies to successfully accomplish the proposed Specific Aims. The PRDMCwill be responsible for managing the recruitment and baseline characterization of participants for the clinical studies as well as the performance of high quality data management and analysis functions for the SCCOR. Participant recruitment is one of the most demanding aspects of clinical studies and the effort and resources it requires are frequently underestimated. Our three clinical projects will recruit from a common pool of patients with COPD. The PRDMC will work closely with project-specific study investigators to ensure that they have an accurate and detailed documentation of study findings. This core will be operational at the outset of the projects and will collaborate on study planning, including research design, development of manuals of operation and data collection forms, monitoring of patient recruitment, data collection/management efforts, and statistical analysis. The PRDMC will be responsible for coordinating and developing reports for the clinical projects related to Data Safety and Monitoring, Adverse Events, and Recruitment Monitoring for review by the Johns Hopkins IRB and a Data Safety and Monitoring Board. In addition, the PRDMC will collaborate with the leaders and co-investigators in the projects and other cores to ensure that the transmission of the SCCOR's findings via reports, abstracts, and manuscripts occur in a timely manner. The PRDMC, therefore, will facilitate the efficient and successfulcompletion of studies proposed in each projectand promote the synthesis of knowledge gained across the various studies. The Core will interact with all of the Projects (1-5) and Core B to provide statistical consultation, recruitment and characterization.