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 阿肯色大学医学科学大学转化研究所（TRI）的任务 （UAMS）是开发新知识和新颖的方法，这些方法将可以衡量地解决复杂 农村和代表性不足的人口的健康挑战。虽然我们的CTSA枢纽具有重要意义 我们在提交和确保国立卫生研究院（NIH）资金的经验，我们在先前的经验 批准过程”是繁殖的，并挑战了我们的枢纽资源和机构赠款的专业知识 官员。定时延误对与飞行员赠款和KL2项目有关的活动施加了严重限制，减少了 我们对我们的使命做出回应并取得进步的能力。我们假设一个 专门的质量保证/质量控制职位将加快事先批准，并获得ERA的批准 NCAT通过建立标准操作程序，向相关赠款接收者提供教育以及 建立指标跟踪系统。我们将通过1）确定质量保证/质量来检验我们的假设 我们的CTSA枢纽的控制位置和质量管理系统，用于使用NCAT的批准流程，2） 通过开发模板和监视向调查人员提供赠款管理教育 通过评估和反馈循环我们过程的有效性。我们提出的申请提供 在我们当地的情况下，我们的机构几乎没有研究的质量控制人员。我们打算 最初通过审查最佳实践和标准操作来构建我们的质量保证/质量控制计划 位于UAMS的现有联邦支持的多站点网络程序可获得的程序。我们 预计该资源将使我们整个机构的其他资金计划受益，例如其他培训 生物医学研究卓越（COBRE）赠款的赠款和中心。建立敬业品质 因此，在我们的CTSA中心内的位置将满足本地枢纽需求，并为赠款管理提供资源 教育将使我们的枢纽其他许多研究人员受益。