Stanford Center for Clinical & Translational Education and Research (Spectrum)

斯坦福临床中心

• 批准号: 10261915
• 负责人: Ruth M O'Hara
• 金额: $ 13.91万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-10-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10261915
• 关键词: Address; Administrative Supplement; Clinical; Clinical Research; Communication; Data; Education; Ensure; Faculty; Funding; Goals; Grant; Health; Human Subject Research; Individual; Knowledge; Lead; Mission; Population; Positioning Attribute; Process; Quality Control; Reporting; Research; Research Support; System; Time; Training and Education; Translational Research; clinical center; design; education research; effectiveness evaluation; experience; federal policy; human subject; human subject protection; implementation science; improved; member; patient population; programs; quality assurance; translational pipeline

Project Summary The mission of Spectrum, Stanford’s CTSA-supported research Hub, is to transform clinical and translational research and education at Stanford and across the Hub network to make it more effective at discovering and implementing data-driven strategies to serve the health needs of individuals and the population and to disseminate that knowledge to trainees and the public. Many Spectrum activities, such as our Pilot Programs and KL2 Scholar Projects, require NCATS prior approval before grant funds can be spent on research. While essential for ensuring compliance with federal policies and appropriate protections for human subjects research, the prior approval process is also lengthy and plagued by inefficiencies. Another barrier to operational efficiency is the lack of a dedicated staff member to oversee other Spectrum-related submissions to the eRA Human Subjects System, obtain institutional approval for documents that are submitted to NCATS, and manage communications with NCATS. Inefficiencies in Spectrum-related administrative interactions with NCATS delay study start up and hamper progress towards our overall goal of transforming clinical and translational research. With this Administrative Supplement, our overall goal is to facilitate consistency, efficiency and enhance the submission of successful CTSA-related information packages to NCATS. Reporting to the CTSA Executive Director, a QC/QA project manager will lead improvement initiatives within Spectrum to enhance the quality of our submissions to NCATS and the eRA Human Subjects System and streamline communications within Spectrum and between Spectrum and NCATS. Our Specific Aims are to: (1) Hire and onboard a full-time quality assurance/quality control (QA/QC) project manager, (2) Develop and implement processes to improve the quality of CTSA-related document submissions to NCATS and the eRA Human Subjects System, promote proactive and timely communications, and enhance engagement and coordination with departments and their CTSA faculty and staff to review and obtain institutional approvals for submitted documents. This includes performing quality reviews and management of all CTSA-related submissions to NCATS, and (3) Use a data-driven approach to evaluate the effectiveness of new processes and use the data to implement continuous and timely improvement. Successful completion of these aims will substantially improve Spectrum’s communication and coordination with NCATS, enable faster research progress, and ultimately help advance our overall mission.

项目摘要 Spectrum是斯坦福大学的CTSA支持的研究中心，其使命是将临床和翻译 研究和教育在斯坦福大学和整个枢纽网络，使其更有效地发现和 实施数据驱动的战略，以满足个人和人口的健康需求， 向受训人员和公众传播这些知识。许多Spectrum活动，例如我们的试点计划 和KL 2学者项目，需要NCATS事先批准，然后才能将赠款资金用于研究。而 对于确保遵守联邦政策和适当保护人类受试者研究至关重要， 事先批准程序也很冗长，而且效率低下。影响运营效率的另一个障碍 缺乏专门的工作人员来监督向eRA Human提交的其他与Spectrum相关的文件 系统，获得提交给NCATS的文件的机构批准，并管理 与NCATS通信。与NCATS延迟相关的频谱管理交互无效 研究启动并阻碍我们实现临床和转化研究转型的总体目标。 通过这份行政补充文件，我们的总体目标是促进一致性和效率，并提高 向国家技术援助中心提交成功的与CTSA有关的成套资料。向CTSA执行官汇报 总监，QC/QA项目经理将领导Spectrum内部的改进计划，以提高 我们向NCATS和eRA人类受试者系统提交的材料，并简化内部沟通 Spectrum和NCATS之间。我们的具体目标是：（1）聘请和船上的全职素质 保证/质量控制（QA/QC）项目经理，（2）开发和实施流程，以提高质量 向NCATS和eRA人类受试者系统提交CTSA相关文件，促进积极主动 及时沟通，并加强与各部门及其CTSA的接触和协调 教职员工审查并获得提交文件的机构批准。这包括执行 对提交给NCATS的所有与CTSA相关的材料进行质量审查和管理，以及（3）使用数据驱动的 评估新流程有效性的方法，并利用数据持续、及时地实施 改进.成功实现这些目标将大大改善频谱的沟通， 与NCATS的协调，使更快的研究进展，并最终帮助推进我们的整体使命。