Core B: Recruitment and Sleep Study Core

核心 B：招募和睡眠研究核心

• 批准号: 9756443
• 负责人: SAMUEL T. KUNA
• 金额: $ 38.85万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 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/9756443
• 关键词: Ambulatory Care Facilities; Area; Center for Translational Science Activities; Clinical; Clinical Protocols; Clinical Research; Complex; Data; Data Collection; Evaluation; Funding; Goals; Iceland; Individual Differences; Informed Consent; Infrastructure; Laboratories; Medical; Multicenter Studies; Multicenter Trials; Obstructive Sleep Apnea; Participant; Patient Recruitments; Pennsylvania; Performance; Policies; Procedures; Process; Program Research Project Grants; Protocols documentation; Records; Reporting; Research; Services; Site; Sleep; Standardization; Testing; Time; Training; United States Agency for Healthcare Research and Quality; United States National Institutes of Health; Universities; Veterans; data management; design; experience; health administration; human subject protection; operation; pharyngeal critical pressure; pressure; programs; quality assurance; recruit; research study

Abstract Well-planned initiatives aimed at accelerating patient recruitment is the key to all successful clinical research studies. Core B, the Recruitment and Sleep Study Core, will provide services to Project 01 and Project 02 in the areas of subject recruitment and performance and scoring of sleep studies. The proposed Core maintains the successful Recruitment and Sleep Study Core established with the previous program project grant. Core B is designed to provide the following important services: 1. Subject Recruitment: The Core will provide an infrastructure with well-trained staff who are proficient in all issues regarding protection of human subjects engaged in research, and who will take primary responsibility for recruitment of subjects in the projects. 2. Performance of Sleep Studies: The Core will standardize the performance and scoring of sleep studies at the University of Pennsylvania and the University of Iceland, and conduct sleep studies at the University of Pennsylvania for Project 1 and Project 2. 3. Performance of More Complex Sleep Studies: The Core will provide skilled technologists for more complex procedures such as performance of polysomnograms to determine critical airway pressure (Pcrit). 4. Review of Data: The Core will provide timely review (for quality and medical alerts) and scoring of all records and generate reports to be transferred to the Biostatical and Data Management Core (Core E). 5. Quality Assurance: The Core will conduct continuous quality assurance procedures to maintain high levels of technical performance of sleep testing at the University of Pennsylvania and University of Iceland as well as scoring of the sleep recordings at the Sleep Study Core Laboratory.

抽象的 旨在加速患者招募的精心计划的计划是所有成功临床研究的关键 研究。核心B，招聘和睡眠研究核心，将为项目01和项目02提供服务 受试者招募，表现和睡眠研究评分领域。拟议的核心坚持认为 成功的招聘和睡眠研究核心是先前的计划项目赠款。核心b 旨在提供以下重要服务： 1。主题招聘：核心将为精通所有人的训练有素的员工提供基础设施 有关保护从事研究的人类受试者的问题，谁将参加主要的问题 在项目中招募主题的责任。 2。睡眠研究的表现：核心将标准化睡眠研究的表现和评分 宾夕法尼亚大学和冰岛大学，并在大学进行睡眠研究 项目1和项目2的宾夕法尼亚州。 3。更复杂的睡眠研究的表现：核心将为更多的技术人员提供更多 复杂的程序，例如确定临界气道压力（PCRIT）的多个多词的性能。 4.数据审查：核心将提供及时的审查（质量和医疗警报）和所有评分 记录和生成报告要转移到生物统计和数据管理核心（核心E）。 5。质量保证：核心将进行连续的质量保证程序以保持高水平 宾夕法尼亚大学和冰岛大学的睡眠测试技术表现 作为睡眠研究核心实验室的睡眠记录评分。