PATIENT RECRUITMENT/DATA MANAGEMENT CORE

核心C：患者招募和数据管理核心（PRDMC）是一个集合体， 优秀的调查人员，工作人员和物质资源，将提供重要的基础设施支持， COPD SCCOR. PRDMC由Jerry A博士领导。Krishnan，医学博士，博士，一个委员会认证的肺 具有COPD患者管理专业知识的医生和经过严格培训的 流行病学家/临床研究者。Dr.丹尼尔Scharfstein，ScD，将作为合作研究者/首席统计师， 指导临床研究的分析，以成功完成拟定的 具体目标。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 临床研究的各个方面及其所需的努力和资源往往被低估。我们 三个临床项目将从一个共同的COPD患者库中招募。PRDMC将发挥作用 与特定项目的研究者密切合作，以确保他们有一个准确和详细的 记录研究结果。这一核心将在项目开始时投入运作， 合作研究规划，包括研究设计、操作手册和数据的开发 收集表格、监测患者招募、数据收集/管理工作和统计 分析. PRDMC将负责协调和编制临床项目报告 与数据安全性和监测、不良事件和招募监测相关，供 约翰霍普金斯IRB和数据安全和监测委员会。此外，PRDMC将与 项目和其他核心的领导人和共同调查员，以确保 SCCOR通过报告，摘要和手稿及时发现。革命民主党， 因此，将有助于有效和成功地完成每个项目中建议的研究， 促进综合各种研究中获得的知识。核心将与所有 项目（1-5）和核心项目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.