Workshop on Clinical Research Management

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NIH研究所代表的会议中，在所有阶段加强和改进临床研究管理已被确定为该计划和国家研究议程的关键目标。在这项申请中，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，在全国范围内促进和推进跨学科和转化性临床研究方面发挥关键资源的作用。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。客户关系管理的总体任务是：就CTSA联盟的标准指标提出建议；制定在CTSA现场实施的方法和具体的实际干预措施；建立伙伴网络和辅导者关系；开发改进的客观证据；出版信息，使科学界能够广泛应用所学到的经验教训。会议研讨会的目标是：1)找出阻碍临床研究发展进程的问题；2)制定解决遇到的问题的创新战略；3)在全国范围内修改、实施和分享最佳实践。这种信息交流将促进改进流程控制的方法，实施经修订的协议处理系统，并在全企业范围内使用衡量标准和信息交换，使CTSA中心成为减轻站点内和协作站点之间的监管负担的典范。2009年的会议将在纳彻尔大楼的NIH校区举行，该校区包括一个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，会议将包括建立联系的机会，使用海报提供个别站点的数据和过程以及吸取的经验教训，以及讲台讲座，展示专家建议在重组方案处理和临床试验管理中的使用。私人助理罗伯特·舍温博士，医学博士，将监督活动，由委员会主席Michael Joyner博士和Tesheia Johnson女士指导整体管理和规划，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，以及为该组织提供整体行政支持。 公共卫生相关性：美国国立卫生研究院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改进过程控制方法，实施修订后的方案处理系统，并在企业范围内使用衡量标准，总体目标是减少阻碍医学研究的监管负担。

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.