CORE--Clinical Core

CORE--临床核心

• 批准号: 7407407
• 负责人: Russell E Ware
• 金额: $ 43.46万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7407407
• 关键词: Address; Adult; Advisory Committees; Arts; Basic Science; Blood; Caring; Cells; Childhood; Client; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Collection; Commit; Comprehensive Health Care; Data; Ensure; Faculty; Family; Health Services; Human Resources; Individual; Informed Consent; Institution; Leadership; Medical center; Mission; Multi-Institutional Clinical Trial; North Carolina; Nurses; Patient Care; Patients; Performance; Physician Assistants; Physicians; Population; Positioning Attribute; Protocols documentation; Recruitment Activity; Research; Research Activity; Research Ethics Committees; Research Personnel; Research Project Grants; Resources; Sampling; Services; Sickle Cell; Sickle Cell Anemia; Site; Social Workers; Study Subject; Translational Research; Universities; base; data management; experience; patient oriented; research study; sample collection; sickling; statistics

The Clinical Core of the Duke-UNC Comprehensive Sickle Cell Center (CSCC) comprises facilities, personnel, scientific resources, and sickle cell disease (SCD) patient populations at the medical centers of both Duke and University of North Carolina at Chapel Hill. The CSCC currently has 1,388 SCD patients evenly split between pediatric and adult populations, with 812 clients having SS homozygous SCD. In addition, through the NC Consortium for Sickle Cell Disease, we are able to draw upon even more of the 3,000 SCD patients in NC for our research activities. The Clinical Core has four primary missions all of which require comprehensive and caring patient interaction: (1) Patient Care - Faculty and staff directly provide integrated, state-of-the-art, and comprehensive health care services to Center patients and their families in coordination with the Patient Service Core. Further, the Core ensures that each patient has access to new research protocols as they become available. (2) Support and Performance of Inter-center Clinical Trials. The Duke-UNC Comprehensive Clinical Center is committed to participationin the multi-center clinical trials conducted by the Comprehensive Sickle Cell Center network and our Clinical Core will provide the infrastructurefor such collaborative studies. The Center has extensive experience in these types of trials and will provide data coordinators to coordinate data entry and analysis with the NHLBI Statistics and Data Management Staff. (3) Support and Performance of Other Clinical Research - The Core will support and conduct the clinical research activities of each of the individual investigators of the Duke-UNC Sickle Ceil Center. Core personnel will help identify and recruit appropriate study subjects, obtain informed consent, reliable specimen collection, accurate data capture, and responsible, non-intrusive administrative services (4) Support for Basic and Translational Research: Core personnel will help identify appropriate study subjects, obtain informed consent, and obtain blood and biologic samples for use in basic research studies, as well as to provide corollary clinical data where required and approved by the IRB. The Clinical Core includes physicians, the Center's Scholar, physician extenders, nurses, social workers, and data coordinators at both constituent institutions, and each site provides both pediatric and adult services. Because they maintain a close relationship with each study subject and are fully knowledgeable about the research being conducted, the Core staff is ideally positioned to ensure the effective implementation of all Center-based and multi-center research projects. Leadership includes Dr. Russell Ware as PI of the Core, and Dr. Eugene P. Orringer as UNC Site Director who ensure quality of patient care. They and the clinician-scientistsin the Core meet regularly as the Intemal Advisory Committee (see Administrative Core) with the Center Director. The IAC acts as a forum to encourage intra-Center collaboration as well as address issues with individual research protocols so they may be addressed in a timely manner.

Duke-Unc综合镰状细胞中心（CSCC）的临床核心包括设施，人员，科学资源和镰状细胞疾病（SCD）的患者人群，位于杜克大学和北卡罗来纳大学教堂山的医学中心。 CSCC目前在儿科和成人人群之间有1,388例SCD患者均匀分配，其中812名患者患有SS纯合SCD。此外，通过NC Consortium的镰状细胞疾病，我们能够利用NC中的3,000名SCD患者进行研究活动。临床核心有四个主要任务，所有这些都需要全面和关怀的患者互动：（1）患者护理 - 教职员工直接提供综合的，最先进的和 全面的医疗服务，向患者及其家人与患者服务核心协调。此外，核心确保每个患者在可用时都可以使用新的研究方案。 （2）中心间临床试验的支持和表现。 Duke-Unc综合临床中心致力于参与综合镰状细胞中心网络进行的多中心临床试验，我们的临床核心将为此类协作研究提供基础设施。该中心在这些类型的试验中具有丰富的经验，并将提供数据协调员，以与NHLBI统计和数据管理人员协调数据输入和分析。 （3）其他临床研究的支持和表现 - 核心将支持和开展杜克·乌斯·镰刀中心每个个别研究人员的临床研究活动。核心人员将帮助识别和招募适当的研究主题，获得知情同意，可靠的标本收集，准确的数据捕获以及负责任的，无侵入的行政服务（4）对基本和翻译研究的支持：核心人员将帮助确定适当的研究对象，获得知情的同意，并获得血液和生物学样本，以便使用血液和生物学样本 基础研究研究以及在IRB需要和批准的情况下提供必然的临床数据。临床核心包括该构成机构的医生，中心的学者，医师扩展器，护士，社会工作者和数据协调员，每个地点都提供儿科和成人服务。因为他们与每个研究主题保持着密切的关系，并且对研究是完全了解的 进行的核心人员是理想的定位，以确保有效实施所有基于中心和多中心的研究项目。领导力包括Russell Ware博士为核心的PI，Eugene P. Orringer博士担任UNC网站主任，以确保患者护理的质量。他们和临床医生 - 科学家在核心中定期与中心主任作为Intemal咨询委员会（请参阅行政核心）会面。 IAC充当鼓励中心协作的论坛，并解决了单个研究协议的问题，因此可以及时解决它们。