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

项目摘要 斯坦福大学CTSA支持的研究中心Spectrum的使命是改变临床和翻译 斯坦福大学和整个中心网络的研究和教育，使其更有效地发现和 实施以数据为导向的战略，以满足个人和人口的健康需求并 向学员和公众传播这方面的知识。许多频谱活动，例如我们的试点计划 和KL2奖学金项目，需要NCATS事先批准，才能将赠款资金用于研究。而当 对确保遵守联邦政策和适当保护人类受试者研究至关重要， 之前的审批过程也很漫长，而且效率低下。运营效率的另一个障碍 是否缺乏专门的工作人员来监督其他与Spectrum相关的提交给时代的人类 主题系统，为提交给NCATS的文件获得机构批准，并管理 与NCATS的通信。与NCATS延迟相关的频谱管理交互效率低下 研究启动并阻碍了我们转变临床和转化性研究的总体目标的进展。 通过这项行政副刊，我们的总体目标是促进一致性和效率，并加强 向NCATS提交成功的CTSA相关信息包。向CTSA执行人员汇报 总监，一名QC/QA项目经理将领导Spectrum内部的改进计划，以提高 我们向NCATS和时代人类科目系统提交的文件并简化了内部沟通 SPECTRUM以及SPECTRUM和NCATS之间的数据。我们的具体目标是：(1)招聘和入职人员具备全职素质 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人类科目系统提交与CTSA相关的文件，促进积极主动 和及时沟通，并加强与各部门及其CTSA的接触和协调 教职员工对提交的文件进行审查并获得机构批准。这包括执行 对所有提交给NCATS的CTSA相关文件进行质量审查和管理，以及(3)使用数据驱动的 评估新流程的有效性并使用数据进行持续和及时实施的方法 进步。这些目标的成功实现将极大地改善Spectrum的沟通和 与NCATS的协调，使研究进展更快，并最终帮助推进我们的整体使命。

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.