Workshop on Clinical Research Management

临床研究管理研讨会

• 批准号: 7802947
• 负责人: ROBERT S SHERWIN
• 金额: $ 7.17万
• 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/7802947
• 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以及在与各个 NIH 研究所代表的会议中，各个阶段临床研究管理的加强和改进已被确定为该计划和国家研究议程的关键目标。在此申请中，我们提议举办一系列年度会议研讨会，通过促进研究人员、监管专业人员和监管机构、IRB 管理者、行业和 NIH 之间的科学交流，作为促进和推进全国跨学科和转化临床研究的关键资源。研讨会的规划和报告任务将委托给国家 CTSA 临床研究管理 (CRM) 工作组及其规划委员会。 CRM 的总体使命是： 为 CTSA 联盟提供有关标准指标的建议；制定在 CTSA 站点实施的方法和具体、实用的干预措施；创建合作伙伴网络和导师与学员关系；开发客观的改进证据；发布信息，以便广泛应用科学界吸取的经验教训。会议研讨会的目的是：1）确定阻碍临床研究开发过程的问题； 2）制定解决所遇到问题的创新策略； 3) 在全国范围内修改、实施和分享最佳实践。这种信息交换将促进过程控制方法的改进、协议处理修订系统的实施以及企业范围内指标和信息交换的使用，这将使 CTSA 中心成为减轻站点内部和合作站点之间监管负担的模型。 2009 年的会议将在 NIH 园区的 Natcher 大楼举行，该大楼包括一个 1,000 个座位的礼堂和一个拥有 9 个会议室的最先进的多功能会议中心，并将包括交流机会、使用海报提供各个站点数据、流程和经验教训，以及讲台讲座来展示在重组方案处理和临床试验管理中如何使用专家建议。 PI 医学博士 Robert Sherwin 博士将监督这些活动，并由委员会主席 Michael Joyner 博士和 Tesheia Johnson 女士指导总体管理和规划，他们将负责主持规划会议、设定里程碑以实现会议时间表，并在会后进行报告。 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以及为该小组提供整体行政支持。 公共健康相关性：NIH 致力于通过开展和资助医学研究来改善公共健康。本次会议的信息交流将促进过程控制方法的改进、方案处理修订系统的实施以及指标在企业范围内的使用，总体目标是减少阻碍医学研究的监管负担。