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.

项目总结/摘要 辛辛那提临床和转化科学与培训中心（CCTST）为研究者提供了 菜单服务。大多数侧重于对从事转化研究的研究人员的直接支持， 生物统计和研究设计;生物医学信息学;参与者互动;伦理和监管 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 一系列试点项目，允许入门级和已建立的调查人员积累初步数据 从而成功获得影响社区健康的校外赠款。 我们的试点计划包括翻译/指导翻译试点赠款;及时奖; 过程/方法赠款;社区卫生赠款;临床研究可行性基金等。的 母公司UL 1 NIH CTSA奖侧重于1）支持研究者发起的转化研究，2） 支持初级调查员的职业发展。其中包括资助人类和脊椎动物 动物研究受NIH延迟发作事先批准政策的约束。为了支持试点项目和KL 2项目， 我们要求补充资金，支持2名工作人员，包括1.0 FTE（12个日历月）， 将致力于直接与调查人员合作， 需要事先批准的文件，以NCATS为他们的项目。 这些QA/QC NIH工作人员具有人类受试者和脊椎动物研究的经验 法规和熟悉UC和辛辛那提儿童医院的政策和程序以及联邦 施政纲要而NIH的QA/QC工作人员熟悉NIH /NCATS流程和电子系统。他们将 通过CCTST评估核心进行质量保证和控制以及过程改进方面的培训。 负责了解人类受试者和脊椎动物的监管环境 所需的研究和文件。通过我们的跨部门劳动力开发部核心，他们将培训研究人员 在我们的CTR在线程序中以视频教程的形式预先批准NIH的要求。 他们发现了一些缺点，这些缺点减缓了调查人员的进程， 叙述如何促进事先批准的过程。侧重于国家技术援助能力评估小组确定的 提交审批的提案：1）HSS字段不准确/不完整; 2）提交不完整; 3） 材料的整体质量; 4）遵守NIH和NCATS政策。建立专门的工作人员， 简化事先批准流程将提高效率，减少错误，并缩短从批准 项目实施。