UC San Diego Clinical and Translational Research Institute

项目总结/摘要 本行政补充资金申请是对NOT-TR-20-014机会的回应， 链接到UC San Diego Altman Clinical and Translational Research Institute（ACTRI）Hub。我们的枢纽， 于2020年成功续约5年，在管理效率方面遇到越来越多的挑战 在NCATS事先批准过程中。这些挑战包括一个复杂的群体， 利益攸关方，包括申请人、ACTRI管理部门、赠款办公室和合同管理部门 （OCGA），机构审查委员会（IRB）和NIH。项目延迟启动的后果 特别是在事先批准阶段的延迟会削弱我们中心的推进能力， 为我们管理的10-15个年度飞行员奖和8个KL 2奖进行研究。因此，我们欢迎 有机会申请资金，以支持在ACTRI，质量保证/质量 控制（QA）专员。QA/QC官员将在临床研究战略的监督下工作 计划办公室、PI和参与事先批准提交的主要项目总监。QA/QC官员将 承担各种直接旨在提高Prior效率的流程改进职责 批准程序。在正式的过程映射和编程规划之后，QA/QC的职责 将包括：1）以基于网络的资源开发形式提供的奖前/申请人社区支持， 服务介绍和咨询服务，针对潜在的申请人的程序和增加 了解事先批准流程及其时间表，2）事先批准提交支持，包括 跟踪和项目管理获奖申请人，文件质量保证，以及利益相关者之间的联系， 和3）流程的批准后管理，包括监管文件更新的及时性， 跟踪工作产品，如出版物和相关的合规保证。QA/QC官员将 开发、调整和实施项目管理工具，我们的中心在这方面经验丰富，例如项目 管理仪表板、时间跟踪软件和流程图。根据NOT的指示，QA/QC 官员将与国家质量保证/质量控制网络合作，并将积极参与资源共享和采用 与我们地区和全国的其他中心联系。

PROJECT SUMMARY/ABSTRACT This administrative supplemental funding request is in response to the NOT-TR-20-014 opportunity, and it is linked to the UC San Diego Altman Clinical and Translational Research Institute (ACTRI) Hub. Our hub, which was successfully renewed in 2020 for 5 years, has experienced increasing challenges in managing efficiency in the NCATS Prior Approval process. These challenges include interactions among a complex group of stakeholders, including the applicant, ACTRI administration, Office of Grants and Contracts Administration (OCGA), the Institutional Review Board (IRB), and the NIH. The consequences of delayed onset of projects are substantial, in particular that delays in a phase of Prior Approval detract from our hub’s ability to advance research for the 10-15 annual Pilot Awards and 8 KL2 awards we administer. Therefore, we welcome the opportunity to apply for funding to support a new full-time role at the ACTRI, a Quality Assurance/Quality Control (QA) Officer. The QA/QC Officer will work under the supervision of the Clinical Research Strategic Initiatives Office, PI, and key Program Directors involved in Prior Approval submissions. The QA/QC officer will undertake a variety of process improvement responsibilities directly aimed at increasing efficiency in Prior Approval procedures. After formal process mapping and programming planning, the QA/QC’s responsibilities will include: 1) Pre-award/Applicant Community Support in the form of web-based resource development, in service presentations, and consultation services aimed at prospective applicants to programs and increasing awareness of the Prior Approval process and its timelines, 2) Prior Approval Submission support, including tracking and project management of awarded applicants, document QA, and linkage between stakeholders, and 3) Post-Approval Management of processes including timeliness of updates to regulatory documents and tracking of work products such as publications and related compliance assurance. The QA/QC Officer will develop, adapt, and implement project management tools, with which our hub is experienced, such as project management dashboards, time tracking software, and process mapping. As directed by the NOT, the QA/QC Officer will collaborate with the national QA/QC network and will be active in resource sharing and adoption with other hubs in our region and nationwide.