Workshop on Clinical Research Management

临床研究管理研讨会

• 批准号: 7675152
• 负责人: ROBERT S SHERWIN
• 金额: $ 2.72万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-15 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7675152
• 关键词: Address; Administrator; Arts; Clinical Research; Clinical Trials; Clinical and Translational Science Awards; Communities; Doctor of Medicine; Educational workshop; Funding; Goals; Individual; Industry; Institutes; Intervention; Learning; Medical Research; Mentors; Methodology; Metric; Mission; Modeling; National Center for Research Resources; Process; Protocols documentation; Public Health; Publishing; Recommendation; Reporting; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Resources; Schedule; Series; Site; Staging; Strategic Planning; Structure; System; TimeLine; United States National Institutes of Health; computerized data processing; improved; innovation; lectures; meetings; posters; programs; public health relevance; research and development; symposium

DESCRIPTION (provided by applicant): In the recent Clinical Translational Science Award strategic planning process and in meetings with representatives for various NIH Institutes, the enhancement and improvement in clinical research management at all stages has been identified as a key goal of the program and for the national research agenda. In this application we are proposing a series of annual conference workshops that will serve as a critical resource in facilitating and advancing interdisciplinary and translational clinical research nationally through promotion of scientific exchange among investigators, regulatory professionals and regulators, IRB administrators, industry, and NIH. The task of planning for and reporting on the workshops will be delegated to the national CTSA Clinical Research Management (CRM) Taskforce and its planning committee. The overall mission of the CRM is to: Make recommendations regarding standard metrics for the CTSA consortium; Develop methodology and specific, practical interventions for implementation at the CTSA sites; Create networks of partners and mentor-mentee relationships; Develop objective evidence of improvement; and Publish information to enable broad application of lessons learned in the scientific community. The conference workshops are geared towards 1) identifying issues which impede the clinical research development process; 2) developing innovative strategies for addressing problems encountered; and 3) modifying, implementing and sharing best practices nationally. This information exchange will promote improved methodology for process control, implementation of revised systems for protocol processing, and enterprise-wide use of metrics and information exchange that will allow the CTSA centers to serve as model for reducing regulatory burdens both within sites and between collaborating sites. The 2009 conference will be held on the NIH Campus at the Natcher Building, which includes a 1,000-seat auditorium, and a state-of- the-art multiuse Conference Center with nine conference rooms, and will include networking opportunities, use of posters to provide individual site data and processes and lessons learned, and podium lectures to demonstrate the use of expert advice in re-structuring protocol processing and clinical trials management. The PI, Dr. Robert Sherwin, M.D., will oversee the activities, with overall administration and planning directed by committee Chairs, Dr. Michael Joyner and Ms. Tesheia Johnson who will have responsibilities of chairing the planning meeting, setting milestones to achieve conference timelines, and reporting after the conference. Dr. Daniel Rosenblum, NCRR, and the CTSA coordinating center will provide critical organization infrastructure with responsibilities for scheduling and arranging the conference, circulating agendas and meeting materials, and overall administrative support to the group. PUBLIC HEALTH RELEVANCE: The NIH is dedicated to improving public health by conducting and funding medical research. The information exchange at this conference will promote improved methodology for process control, implementation of revised systems for protocol processing, and enterprise-wide use of metrics with the overall goal of reducing regulatory burdens that hinder Medical research.

描述（由申请人提供）：在最近的临床转化科学奖战略规划过程中，在与NIH各研究所代表的会议中，临床研究管理各阶段的增强和改进已被确定为该计划和国家研究议程的关键目标。在这一申请中，我们提议举办一系列年度会议研讨会，通过促进研究者、监管专业人员和监管者、IRB管理者、行业和NIH之间的科学交流，这些研讨会将成为促进和推进全国跨学科和转化临床研究的关键资源。计划和报告研讨会的任务将委托给国家CTSA临床研究管理（CRM）工作组及其计划委员会。CRM的总体任务是：为CTSA联盟提出有关标准指标的建议；制定方法和具体、实际的干预措施，以便在CTSA场址实施；建立合作伙伴网络和师徒关系；制定改进的客观证据；发布信息，使科学界能够广泛应用所吸取的经验教训。会议研讨会旨在1)确定阻碍临床研究发展进程的问题；2)针对遇到的问题制定创新策略；3)在全国范围内修改、实施和分享最佳做法。这种信息交换将促进过程控制方法的改进，修订协议处理系统的实施，以及企业范围内度量标准和信息交换的使用，这将使CTSA中心成为减少站点内部和合作站点之间监管负担的典范。2009年的会议将在美国国立卫生研究院校园内的Natcher大楼举行，该大楼包括一个1000个座位的礼堂和一个拥有9个会议室的最先进的多用途会议中心，并将包括建立网络的机会，使用海报提供个人现场数据、过程和经验教训，以及讲台演讲，以展示在重组协议处理和临床试验管理中使用专家建议。项目负责人，医学博士Robert Sherwin博士将监督活动，委员会主席Michael Joyner博士和Tesheia Johnson女士将负责主持计划会议，设定实现会议时间表的里程碑，并在会议结束后报告。NCRR的Daniel Rosenblum博士和CTSA协调中心将提供关键的组织基础设施，负责安排和安排会议，分发议程和会议材料，并为小组提供全面的行政支持。