PATIENT RECRUITMENT/DATA MANAGEMENT CORE

患者招募/数据管理核心

基本信息

批准号：
7499337
负责人：
Jerry A. Krishnan
金额：
$ 41.9万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-14 至 2012-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7499337
关键词：
Adverse event Biometry Chronic Obstructive Airway Disease Clinical Clinical Investigator Clinical Research Clinical Trials Data Monitoring Committees Complement Consultations Critical Care Data Data Analyses Data Collection Data Quality Data Set Databases Development Doctor of Philosophy Documentation Enrollment Ensure Epidemiologist Epidemiology Head Information Systems Knowledge Lung Manuals Manuscripts Medicine Methods Monitor Operative Surgical Procedures Participant Patient Monitoring Patient Recruitments Patients Performance Physicians Procedures Public Health Schools Quality Control Recruitment Activity Reporting Research Design Research Ethics Committees Research Infrastructure Research Personnel Resources Safety System Training Work abstracting data management design innovation medical schools programs quality assurance repository transmission process

项目摘要

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.

核心 C：患者招募和数据管理核心 (PRDMC) 是优秀的研究人员、工作人员和物质资源将为该项目提供重要的基础设施支持慢性阻塞性肺病 SCCOR。 PDMC 由医学博士、哲学博士 Jerry A. Krishnan 博士领导，他是一位经过委员会认证的肺科医师拥有慢性阻塞性肺病患者管理专业知识和经过严格培训的医生流行病学家/临床研究者。 Daniel Scharfstein 博士（ScD）将担任联合研究员/首席统计学家 PRDMC 并指导临床研究分析以成功完成拟议的具体目标。 PRDMC 将负责管理招募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。参与者招募是要求最高的任务之一临床研究的各个方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慢性阻塞性肺病患者的共同库中招募。 PRDMC将发挥作用与特定项目的研究调查人员密切合作，确保他们获得准确、详细的信息研究结果的记录。该核心将在项目开始时投入运行，并将协作研究规划，包括研究设计、操作和数据手册的开发收集表格、患者招募监测、数据收集/管理工作以及统计分析。 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的信息，以供审查约翰霍普金斯大学 IRB 和数据安全与监控委员会。此外，PRDMC 将与项目和其他核心的领导者和共同研究者，以确保传输 SCCOR 通过报告、摘要和手稿及时得出调查结果。人民民主管理委员会，因此，将有助于高效、成功地完成每个项目中提出的研究，促进通过各种研究获得的知识的综合。核心将与所有交互项目 (1-5) 和核心 B 提供统计咨询、招募和特征描述。