LCenter for Clinical and Translational Science and Training

项目摘要/摘要 辛辛那提临床和翻译科学与培训中心(CCTST)为研究人员提供了 服务菜单。大多数侧重于对从事翻译研究的调查人员提供直接支持，包括 生物统计学和研究设计；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；以及社区参与。我们提供 一系列试点项目，允许入门级和老牌调查人员积累初步数据 从而成功地获得影响社区健康的校外赠款。 我们的试点计划包括翻译/指导翻译试点助学金；即时奖； 过程/方法补助金、社区卫生补助金、临床研究可行性基金等。这个 家长UL1 NIH CTSA奖的重点是1)支持研究人员发起的翻译研究和2) 支持初级调查员的职业发展。其中包括对人类研究对象和脊椎动物的资助 动物研究须受美国国立卫生研究院延迟起效事先批准政策的约束。为了支持Pilot和KL2计划， 我们正在请求补充资金，支持2名工作人员，包括1.0 FTE(12个日历月)，支持 由机构资助，他们将致力于直接与调查人员合作，准备和提交 他们的项目需要事先向NCATS提供批准文件。 这些质量保证/质量控制人员在人类和脊椎动物研究方面有经验。 法规，熟悉加州大学和辛辛那提儿童医院的政策和程序以及联邦 政策。NIH的QA/QC人员熟悉NIH/NCATS的流程和电子系统。他们会 通过CCTST评估核心，接受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调控环境 所需的研究和文档。通过我们的Transans。员工团队开发人员CORE，他们将培训研究人员 美国国立卫生研究院要求在我们的CTROnline计划中以视频教程的形式事先批准。 他们已经发现了减缓调查人员调查进程的缺陷，并将包括 关于如何促进事先批准过程的叙述。关注NCATS在以下方面确定的挑战 提交审批的提案：1)不准确/不完整的HSS字段；2)不完整的提交；3) 材料的整体质量；以及4)遵守NIH和NCATS的政策。创建专职员工 促进之前的审批流程将提高效率、减少错误并缩短从审批到 从项目到实施。

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.