C4 - Clinical Research

C4 - 临床研究

• 批准号: 8076896
• 负责人: thomas matthew habermann
• 金额: $ 32.77万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8076896
• 关键词: Adverse event; Bioinformatics; Biometry; Clinical; Clinical Research; Clinical Trials; Consent Forms; Data; Development; Doctor of Medicine; Enrollment; Ensure; Epidemiology; Funding; Goals; Guidelines; Link; Molecular Epidemiology; Monitor; Monitoring Clinical Trials; Patients; Process; Protocols documentation; Quality Control; Recruitment Activity; Reporting; Reproduction spores; Research; Research Ethics Committees; Research Project Grants; Resources; Sampling; Schedule; Site; Testing; Translational Research; Work; meetings; member; patient safety; protocol development

The UI/MC SPORE Clinical Research Core (CRC) has as its primary goal to be the direct translational link between research projects and clinical research emanating from these projects. The CRC coordinates the development of clinical trials, assists in patient accrual, manages and reports adverse events to appropriate agencies, and provides quality control on clinical trial data. The CRC also hosts the Molecular Epidemiology Resource. The CRC provides a critical link between clinical research and the specific projects and cores. The CRC is co-directed by Brian Link, M.D., at the HCCC and Thomas M. Habermann, M.D., at the MCCC. Other key members of the CRC are Protocol Development Coordinators (PDC), Clinical ResearchAssociates (CRA), and Research Assistants (RA) located at both sites. The PDC functions with the PI and IRB to develop and activate the clinical trial and consent form. The CRA and RA assists in recruiting patients to the trials, schedules protocol tests, and collaborates with the Biospecimens Core and the specific research projects to ensure that translational research samples from patients are obtained according to protocol guidelines. The CRA and RA arranges for data entry into the Biostatistics and Bioinformatics Core. During the previous funding period, the CRC was very active and developed 4 clinical trials that accrued 113 patients. In addition, the Molecular Epidemiology Resource accrued 1,331 eligible patients through December 31, 2005. The CRC has worked with the Pis to develop the 4 projects in this competitive renewal and is in the process of protocol development for clinical trials outlined in Projects 1, 2, and 4. In addition, the CRC will provide ongoing support for the Molecular Epidemiology Resource that is being used in Project 3 and a developmental project, and is expected to be an increasingly valuable resource as it matures. The CRC will continue to recruit patients to the 4 trials that remain active from the first funding period and follow patients already enrolled until protocol endpoints are met. The CRC is also responsible for the clinical trials monitoring plans, which have been fully developed at both sites. These monitoring plans assure that the appropriate expertise is available to review the patient protocols, obtain IRB approval, and provide periodic review of ongoing protocol review to maximize patient safety. In summary, the CRC has been an extremely valuable resource during the first funding period. It has functioned at a high level and will be a very important core in the next funding period to support the clinical trials research, translational research projects, and epidemiology projects.

UI/MC SPORE临床研究核心（CRC）的主要目标是直接翻译 研究项目与这些项目产生的临床研究之间的联系。CRC协调 开展临床试验，协助患者招募，管理不良事件并向适当的 并对临床试验数据进行质量控制。CRC还主办了分子流行病学 Resource. CRC提供了临床研究与具体项目和核心之间的关键联系。的 CRC由Brian Link，M.D.共同指导，在HCCC和托马斯M.哈伯曼，医学博士，在MCCC。其他 CRC的主要成员是方案开发协调员（PDC）、临床研究助理 (CRA)和研究助理（RA）位于两个地点。PDC与PI和IRB一起工作， 启动临床试验和同意书CRA和RA协助招募患者参加试验， 安排协议测试，并与生物标本核心和具体的研究项目合作， 确保根据方案指南从患者中获得转化研究样本。的 CRA和RA安排将数据输入生物统计学和生物信息学核心。前一 在资助期间，CRC非常活跃，开发了4项临床试验，累积了113名患者。此外，本发明还提供了一种方法， 到2005年12月31日，分子流行病学资源累积了1，331名合格的患者。的CRC 我已与Pis合作，在此次竞争性续约中开发了4个项目，目前正在进行协议 项目1、2和4中概述的临床试验的开发。此外，儿童权利委员会将提供持续的支持， 用于项目3和开发项目的分子流行病学资源， 随着它的成熟，预计将成为越来越有价值的资源。CRC将继续招募患者， 4项试验从第一个资助期起一直处于活跃状态，并随访已入组的患者，直至方案 达到终点。CRC还负责临床试验监测计划，该计划已得到充分实施。 在这两个网站上开发。这些监测计划确保有适当的专门知识可供审查 患者方案，获得IRB批准，并对正在进行的方案审查进行定期审查，以最大限度地 患者安全。总之，在第一个供资期内，化学品审查委员会是一个极其宝贵的资源。 它在高级别上运作，将在下一个供资期成为支持 临床试验研究、转化研究项目和流行病学项目。