PATIENT RECRUITMENT/DATA MANAGEMENT CORE

点击翻译按钮获取中文摘要

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.