PATIENT RECRUITMENT/DATA MANAGEMENT CORE

患者招募/数据管理核心

• 批准号: 7924560
• 负责人: Jerry A. Krishnan
• 金额: $ 43.92万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7924560
• 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 Set; Databases; Development; Doctor of Philosophy; Documentation; Enrollment; Ensure; Epidemiologist; Epidemiology; Head; Knowledge; Lung; Manuals; Manuscripts; Medicine; Methods; Monitor; Operative Surgical Procedures; Participant; 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

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：患者招聘和数据管理核心（PRDMC）是一个组装 杰出的调查人员，员工和材料资源将为 COPD SCCOR。由董事会认证的杰里·克里希南（Jerry A. Krishnan）博士杰里·A·克里希南（Jerry A. 具有专业知识的医师在管理COPD患者和经过严格培训的患者方面具有专业知识 流行病学家/临床研究者。 SCD的Daniel Scharfstein博士将是共同投资者/主要统计学家 PRDMC并指导临床研究的分析以成功完成所提出的 具体目标。 PRDMCWILL负责管理招聘和基线 参与者的临床研究以及高质量数据的表现 SCCOR的管理和分析功能。参与者招聘是最苛刻的 临床研究的各个方面及其所需的精力和资源经常被低估。我们的 三个临床项目将从普通的COPD患者中招募。 PRDMC将起作用 与特定于项目的研究人员紧密相关，以确保他们具有准确而详细的 研究结果的文档。该核心将在项目开始时运行，并将 在研究计划上进行合作，包括研究设计，操作手册和数据的开发 收集表格，监测患者招聘，数据收集/管理工作以及统计 分析。 PRDMC将负责协调和开发临床项目的报告 与数据安全和监控，不良事件以及招聘监控有关，以进行审查 Johns Hopkins IRB和数据安全与监测委员会。此外，PRDMC将与 在项目和其他核心中的领导者和共同研究者，以确保传播 SCCOR通过报告，摘要和手稿的发现及时出现。 PRDMC， 因此，将促进每个项目中提出的研究的有效和成功完成 促进各种研究中获得的知识的综合。核心将与所有 项目（1-5）和核心B提供统计咨询，招聘和表征。