CTSA Admin Supp QAQC - UL1 - Revision

摘要 阿肯色州大学医学转化研究所的使命 （UAMS）是开发新的知识和新的方法，将可衡量地解决复杂的 农村和代表性不足的人口面临的健康挑战。虽然我们的CTSA中心有很大的 在提交和获得美国国立卫生研究院（NIH）资金的经验，我们的经验与“前 审批程序”是一项繁重的工作，对我们的中心资源和机构赠款的专门知识提出了挑战 官员时间上的延误严重限制了与试点赠款和KL 2项目有关的活动， 我们的能力，以回应我们的使命，并取得进展的整体目标，我们的赠款。我们假设 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 建立度量跟踪系统。我们将通过以下方式检验我们的假设：1）建立质量保证/质量 我们的CTSA中心的控制位置和质量管理体系，用于NCATS的批准流程，以及2） 通过开发模板和监测，向调查人员提供赠款管理教育 通过评估和反馈循环来提高我们流程的有效性。我们提出的申请提供 创新在我们的本地环境中，我们的机构很少有专门从事研究的质量控制人员。我们打算 通过审查最佳实践和标准操作，初步建立我们的质量保证/质量控制计划 可从位于UAMS的现有联邦支持的多站点网络程序获得的程序。我们 我预计，这一资源将有利于我们整个机构的其他资助计划，如其他培训 生物医学研究卓越中心（COBRE）。建立专注的质量 因此，我们在CTSA中心内的一个职位将满足当地中心的需求，并为赠款管理提供资源 这将使我们中心的许多其他研究人员受益。

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.