CTSA Admin Supp QAQC - UL1 - Revision

CTSA 管理补充 QAQC - UL1 - 修订版

• 批准号: 10158964
• 负责人: Laura P James
• 金额: $ 15.69万
• 依托单位: UNIV OF ARKANSAS FOR MED SCIS
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10158964
• 关键词: Address; Administrative Supplement; Administrator; Arkansas; Award; Awareness; Centers of Research Excellence; Clinical Trials; Complex; Development; Education; Effectiveness; Ensure; Evaluation; Feedback; Funding; Grant; Health; Human Subject Research; Individual; Institution; Knowledge; Leadership; Measurable; Medical; Mission; Monitor; Positioning Attribute; Procedures; Process; Quality Control; Recording of previous events; Regulatory Affairs; Research; Research Activity; Research Institute; Research Personnel; Resources; Rural Population; Science; Secure; System; Testing; Training; Translational Research; Underrepresented Populations; United States National Institutes of Health; Universities; career; experience; human subject; implementation research; innovation; knowledge base; member; novel strategies; programs; quality assurance

Abstract The mission of the Translational Research Institute (TRI) at the University of Arkansas for Medical Sciences (UAMS) is to develop new knowledge and novel approaches that will measurably address the complex health challenges of rural and underrepresented populations. While our CTSA hub has significant experience in submitting and securing National Institutes of Health (NIH) funding, our experience with the “prior approval process” was burdensome and challenged our hub resources and the expertise of institutional grant officials. Delays in timing placed severe limitations on activities related to pilot grants and KL2 projects, reducing our ability to respond to our mission and make progress on the overall aims of our grant. We hypothesize that a dedicated Quality Assurance/Quality Control position will expedite prior approval and eRA approvals from NCATS by establishing standard operating procedures, providing education to relevant grant recipients, and establishing a metrics tracking system. We will test our hypothesis by 1) establishing a Quality Assurance/Quality Control position and quality management system for our CTSA hub for approval processes with NCATS and 2) delivering grants management education to investigators through the development of templates and monitoring the effectiveness of our process through evaluation and feedback loops. Our proposed application provides innovation in our local context in that our institution has few research-specific quality control staff. We intend to build our quality assurance/quality control program initially by reviewing best practices and standard operating procedures available from an existing federally supported multisite network program located at UAMS. We anticipate that this resource will benefit other funded programs throughout our institution, such as other training grants and Centers of Biomedical Research Excellence (COBRE) grants. Establishing a dedicated quality position within our CTSA hub will thus serve local hub needs and provide a resource for grants management education that will benefit numerous other researchers in our hub.

抽象的 阿肯色医学大学转化研究所 (TRI) 的使命 （UAMS）旨在开发新知识和新方法，以可衡量地解决复杂的问题 农村和代表性不足人群的健康挑战，而我们的 CTSA 中心也面临着重大挑战。 在提交和获得美国国立卫生研究院 (NIH) 资金方面的经验，我们在“先前的研究”方面的经验 审批流程”非常繁重，对我们的中心资源和机构拨款的专业知识提出了挑战 时间上的延误严重限制了与试点拨款和 KL2 项目相关的活动，从而减少了 我们有能力响应我们的使命并在我们赠款的总体目标上取得进展。 专门的质量保证/质量控制职位将加快事先批准和 eRA 批准 NCATS 通过建立标准操作程序、向相关赠款接受者提供教育，以及 我们将通过 1) 建立质量保证/质量来检验我们的假设。 我们的 CTSA 中心的控制位置和质量管理系统，用于 NCATS 的审批流程和 2) 通过开发模板和监控向调查人员提供赠款管理教育 我们提出的应用程序通过评估和反馈循环提供了我们流程的有效性。 我们打算在当地进行创新，因为我们的机构几乎没有专门从事研究的质量控制人员。 首先通过审查最佳实践和标准操作来建立我们的质量保证/质量控制计划 可以从位于 UAMS We 的现有联邦支持的多站点网络计划获取程序。 预计该资源将使我们机构的其他资助项目受益，例如其他培训 补助金和生物医学卓越研究中心 (COBRE) 补助金。 因此，我们 CTSA 中心的位置将满足当地中心的需求，并为赠款管理提供资源 教育将使我们中心的许多其他研究人员受益。