Tufts Clinical and Translational Science Institute (Pilot Supplement)

摘要 拟议的项目将把塔夫茨临床和翻译科学研究所(CTSI)聚集在一起 教职员工解决与管理国家中心相关的翻译障碍 用于推进翻译科学(NCATS)的事先审批请求。塔夫茨CTSI将在 我们长期的研究流程改进(RPI)和试点研究计划要开发 新的工具、战略、质量改进指标，并部署专门人员 对中心向NCATS和时代提交的预先审批请求进行质量审查 人类主体制度。我们还将创建工具和流程，以更有效地 与调查人员协作准备事前审批包，以请求审批 CTSA资助的研究，并与机构和NCATS代表联系以管理 之前与审批相关的流程。相关的事前审批请求包括但不限于 至：1)更改关键人员，2)增加外来组件，3)请求结转 资金，以及4)所有新导师要求进行动物和人类对象研究 临床研究学者(KL2)项目和某些先导研究项目。预赛 我们的工作重点将是加强对以下项目的事前审批请求包的监控 CTSA资助的动物和人类对象研究项目，特别是 对于我们的枢纽来说，这是一项具有挑战性且耗时的任务。为了实现这些目标，我们建议扩大 RPI和试点研究计划人员在开发工具和 准备之前审批包的流程，执行增强的质量保证/质量 在提交前对包裹进行控制(QA/QC)审查，并分享基于证据的最佳 提交NCATS事先审批请求的做法，目的是改善 NCATS事先审批申请的质量、一致性和效率。与塔夫茨CTSI的 在领导国家质量和过程改进计划方面，我们预计 拟议的工作将对改进NCATS事前审批申请产生重大影响 在我们的本地枢纽，也在全国范围内，因为我们贡献资源并为 CTSA财团。

SUMMARY The proposed project will bring together Tufts Clinical and Translational Science Institute (CTSI) faculty and staff to address translational roadblocks associated with managing National Center for Advancing Translational Science (NCATS) Prior Approval requests. Tufts CTSI will build on our long-standing Research Process Improvement (RPI) and Pilot Studies programs to develop new tools, strategies, quality improvement metrics, and to deploy dedicated personnel to perform quality reviews of hub Prior Approval request submissions to NCATS and the eRA Human Subjects System. We will also create tools and processes to more effectively collaborate with investigators on preparing Prior Approval packages to request approval for CTSA-funded research and to liaise with institutional and NCATS representatives to manage Prior Approval-related processes. Relevant Prior Approval requests include, but are not limited to: 1) changes in key personnel, 2) addition of a foreign component, 3) request to carryover funds, and 4) requests to conduct animal- and human-subjects research by all new Mentored Clinical Research Scholar (KL2) projects and certain Pilot Studies projects. The preliminary focus of our efforts will be an increased monitoring of Prior Approval request packages for CTSA-funded animal- and human-subjects research projects, which have been particularly challenging and time-consuming for our hub. To achieve these goals, we propose expanding the roles and responsibilities of RPI and Pilot Studies program personnel to develop tools and processes for preparing Prior Approval packages, perform enhanced quality assurance/quality control (QA/QC) reviews of packages prior to submission, and to share evidence-based best practices for submission of NCATS Prior Approval requests with the goal of improving the quality, consistency, and efficiency of NCATS Prior Approval requests. With Tufts CTSI's experience leading national quality and process improvement initiatives, we anticipate the proposed work will have a significant impact on improving NCATS Prior Approval requests locally at our hub, but also nationally as we contribute resources and provide trainings to the CTSA Consortium.