Tufts Clinical and Translational Science Institute (Pilot Supplement)

塔夫茨临床与转化科学研究所（试点增刊）

• 批准号: 10260036
• 负责人: Harry P. Selker
• 金额: $ 23.24万
• 依托单位: TUFTS UNIVERSITY BOSTON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10260036
• 关键词: Addendum; Address; Animals; Businesses; Clinical; Clinical Research; Clinical Sciences; Clinical and Translational Science Awards; Communication; Consumption; Effectiveness; Evaluation; Faculty; Failure; Foundations; Funding; Goals; Human Resources; Human Subject Research; Infrastructure; Institutes; Instruction; International; International Aspects; Intervention; Knowledge; Mentors; Methods; Monitor; Patients; Performance; Pilot Projects; Process; Quality Control; Research; Research Personnel; Research Project Grants; Resources; Role; Services; Support System; System; Time; Training; Translating; Translational Research; Translations; United States National Institutes of Health; Work; clinical application; evidence base; expectation; experience; human subject; improved; innovation; operation; programs; quality assurance; tool

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.

概括 拟议的项目将汇集塔夫茨临床和转化科学研究所（CTSI） 教职员工解决与管理国家中心相关的转化障碍 用于推进转化科学 (NCATS) 事先批准请求。塔夫茨 CTSI 将建立在 我们长期开展的研究过程改进 (RPI) 和试点研究计划 新工具、策略、质量改进指标，并部署专门人员 对向 NCATS 和 eRA 提交的中心事先批准请求进行质量审查 人类受试者系统。我们还将创建工具和流程，以更有效地 与调查人员合作准备事先批准包以请求批准 CTSA 资助的研究并与机构和 NCATS 代表联络进行管理 事先批准相关流程。相关事先批准请求包括但不限于 目的：1) 关键人员变动，2) 增加外国成分，3) 结转请求 资金，以及 4) 要求所有新的导师进行动物和人类受试者研究 临床研究学者 (KL2) 项目和某些试点研究项目。初步的 我们努力的重点将是加强对预先批准请求包的监控 CTSA 资助的动物和人类研究项目，特别是 对于我们的中心来说既具有挑战性又耗时。为了实现这些目标，我们建议扩大 RPI 和试点研究计划人员开发工具和 准备事先批准包的流程，执行增强的质量保证/质量 在提交之前对包裹进行控制（QA/QC）审查，并分享基于证据的最佳结果 提交 NCATS 事先批准请求的做法，旨在改进 NCATS 事先批准请求的质量、一致性和效率。与塔夫茨 CTSI 合作 经验领先的国家质量和流程改进举措，我们预计 拟议的工作将对改善 NCATS 事先批准请求产生重大影响 在我们的中心本地，而且在全国范围内，我们为 CTSA 联盟。