LCenter for Clinical and Translational Science and Training

临床和转化科学与培训中心

• 批准号: 10384860
• 负责人: JAMES E. HEUBI
• 金额: $ 7.71万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-14 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10384860
• 关键词: Address; Adherence; Administrative Supplement; Animal Experimentation; Award; Biometry; Calendar; Center for Translational Science Activities; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical and Translational Science Awards; Community Health; County; Data; Documentation; Environment; Ethics; Evaluation; Extramural Activities; Familiarity; Family Practice; Funding; Goals; Grant; Health; Human Subject Research; Institution; Lead; Measures; Medical center; Mentors; Methods; Modification; Monitor; Parents; Participant; Pediatric Hospitals; Policies; Preparation; Procedures; Process; Quality Control; Regulation; Research; Research Design; Research Personnel; Science; Services; System; Time; Training; Translational Research; United States National Institutes of Health; Universities; Vertebrates; Work; Workforce Development; acute care; animal research subject; base; biomedical informatics; career; career development; clinical center; community engagement; community organizations; experience; feasibility research; federal policy; human subject; improved; innovation; interest; investigator-initiated translational research; member; practice-based research network; programs; quality assurance; response; success; translational scientist; translational study

PROJECT SUMMARY/ABSTRACT The Cincinnati Center for Clinical and Translational Science and Training (CCTST) provides investigators a menu of services. Most focus on direct support for investigators engaged in translational research including biostatistical and research design; biomedical informatics; participant interactions; ethics and regulatory support; workforce development; team science; acute care research; and community engagement. We provide a portfolio of pilot programs that allow entry level and established investigators to accrue preliminary data leading to success in obtaining extramural grants impacting the health of the community. Our pilot programs include Translational/Mentored Translational Pilot Grants; Just-in-Time Awards; Processes/Methods Grants; Community Health Grants; Clinical Research Feasibility Fund, and others. The parent UL1 NIH CTSA award focuses on 1) support of investigator initiated translational research and 2) support of junior investigator career development. These include funding of human subject and vertebrate animal research subject to the NIH delay onset prior approval policy. To support the pilot and KL2 programs, we are requesting supplemental funds supporting 2 staff comprising 1.0 FTE (12 calendar months), supported by institutional funding who will be dedicated to work directly with investigators to prepare and submit the required prior approval documentation to NCATS for their projects. These QA/QC NIH staff have experience with human subjects and vertebrate animal research regulations and familiarity with UC and Cincinnati Children’s Hospital policies and procedures and federal policies. The QA/QC NIH staff are familiar with the NIH /NCATS processes and electronic systems. They will be trained in quality assurance and control, and process improvement though CCTST Evaluation Core. Responsible for understanding the regulatory environment governing human subject and vertebrate animal research and documentation required. Through our Trans. Workforce Dev. Core, they will train researchers on NIH requirements for prior approval in the form of video tutorials in our CTROnline program. They have identified shortcomings that have slowed the process for investigators and will include narratives of how to facilitate the process of prior approval. Focusing on challenges identified by NCATS in proposals being submitted for approval: 1) Inaccurate/incomplete HSS fields; 2) Incomplete submissions; 3) Overall quality of materials; and 4) Adherence to NIH and NCATS policies. Creating dedicated staff for facilitating prior approval process will create efficiencies, reduce errors, and decrease time from approval of projects to implementation.

项目摘要/摘要 辛辛那提临床和转化科学与培训中心（CCTST）为研究人员提供了 服务菜单。大多数关注直接支持对从事转化研究的调查人员的支持 生物统计和研究设计；生物医学信息；参与者互动；道德和监管 支持;劳动力发展；团队科学；急性护理研究；和社区参与。我们提供 试点计划的投资组合，允许入门级和既定调查人员获得初步数据 成功地获得了影响社区健康的壁外赠款。 我们的试点计划包括翻译/指导的转化飞行员赠款；即时奖励； 过程/方法赠款；社区健康赠款；临床研究可行性基金等。这 父母UL1 NIH CTSA奖的重点是1）研究人员的支持启动转化研究和2） 支持初级调查员职业发展的支持。这些包括对人类和脊椎动物的资金 动物研究受到NIH延迟发作事先批准政策的约束。为了支持飞行员和KL2计划， 我们要求补充资金，支持2名员工完成1.0 FTE（12个日历月），支持 通过机构资金，他们将致力于直接与调查人员合作，以准备和提交 需要事先向NCAT提供其项目的批准文件。 这些质量保证/QC NIH员工在人类受试者和脊椎​​动物研究方面具有经验 法规以及对UC和辛辛那提儿童医院政策和程序的熟悉以及联邦 政策。 QA /QC NIH的工作人员熟悉NIH /NCAT的过程和电子系统。他们会的 接受质量保证和控制的培训，并通过CCTST评估核心进行过程改进。 负责理解管理人类主体和脊椎动物的监管环境 需要研究和文档。通过我们的跨性别。劳动力开发人员。核心，他们将培训研究人员 NIH要求在我们的Ctronline计划中以视频教程的形式获得事先批准。 他们已经确定了减慢调查人员过程的缺点，并将包括 如何促进事先批准过程的叙述。专注于NCAT在 提交批准的建议：1）不准确/不完整的HSS领域； 2）不完整的提交； 3） 材料的总体质量； 4）遵守NIH和NCATS政策。为 促进事先批准过程将创造效率，降低错误并减少批准的时间 实施项目。