Proposal for Dedicated QAQC Personnel to Promote Consistency and Efficiency of CTSA-related Submissions

项目摘要/摘要 本行政副刊描述了向UC提供详细监管协助的工作人员职位 戴维斯临床和翻译科学中心(CTSC)。具体而言，这一新职位将协助反恐委员会。 准备和跟踪延迟性人类受试者研究的申请。当资金来自 美国国立卫生研究院(NIH)国家高级翻译科学中心(NCATS) 受试者的研究需要该机构的审查和批准，然后才能开始拨款项目。这 由临床和翻译基金资助的Pilot Awards和KL2项目通常需要事先审批 科学奖(CTSA)拨款。开发需要事先批准的应用程序需要 收集、汇编、组织关键信息并将其提交到联邦系统。为了确保这些 申请是否完整、准确并可供审查是一项复杂而耗时的任务。 此外，NIH要求由联邦资助的研究产生的出版物符合公众 访问策略。这一进行中的进程需要确定符合标准的适用出版物， 确定适当的合规途径，并促进年度报告的合规。 这些步骤对作者来说并不总是直截了当的，往往需要父母付出巨大的努力 提供联邦资金的获奖者。这项工作的细节性质与技能很好地一致 需要管理之前的审批申请。 这两项责任对成功的CTSA至关重要，如果不能有效和一致地履行， NCATS的工作人员很有可能浪费时间，从而延误 开始研究并收到年度资助。被雇来承担这些任务的人 职责将嵌入反恐委员会，培训并熟悉机构和联邦机构 他还将在反恐委员会翻译研究合规委员会中发挥关键作用。必备条件 技能和职责将产生集成良好、准备充分且高度合规的应用程序和 向NCATS报告。这位敬业的个人还将能够参加NCATS质量保证和 质量控制会议，以帮助传播为促进这些过程而开发的技能和工具。 促进一致和有效率地将完整、准确的CTSA相关信息提交给 NCATS，加州大学戴维斯分校CTSC建议雇用和部署一名具有必要技能和 主题专门知识：1)提高申请事先审批的一致性；2)开发系统以 简化所需合规报告的收集和审查；以及3)管理和传播质量 改进工具，促进遵守赠款报告。

PROJECT SUMMARY/ABSTRACT This Administrative Supplement describes a staff position to provide detailed regulatory assistance to the UC Davis Clinical and Translational Science Center (CTSC). Specifically, this new position will assist the CTSC with the preparation and tracking of applications for delayed onset human subjects' research. When funded by the National Institutes of Health (NIH) National Center for Advancing Translational Science (NCATS), human subjects' research requires review and approval by the agency before grant-funded projects can begin. This prior approval process is common with Pilot Awards and KL2 projects funded by the Clinical and Translational Science Award (CTSA) grant. The development of applications that require Prior Approval necessitate the collection, assembly, organization, and submission of key information into a federal system. To ensure these applications are complete, accurate, and ready for review is a complex and time-consuming task. In addition, the NIH requires that publications resulting from federally funded research comply with the Public Access Policy. This ongoing process requires the identification of applicable publications that meet the criteria, determination of the appropriate compliance pathway, and facilitation of compliance for the annual report. These steps are not always straightforward to authors and often take significant effort on the part of the parent award recipient that provides the federal funding. The detailed nature of this work aligns well with the skills required to manage Prior Approval applications. Both responsibilities are essential to a successful CTSA, and if not performed efficiently and consistently, there is great potential of wasted time on the part of NCATS staff and consequent delays in the commencement of research and receipt of annual funding. The individual hired to assume these responsibilities will be embedded within the CTSC, trained on and familiar with the institutional and federal systems, and will play a key role with the CTSC Translational Research Compliance Committee. The requisite skills and responsibilities will yield well integrated, fully prepared, and highly compliant applications and reports to NCATS. This dedicated individual will also be able to participate in NCATS Quality Assurance and Quality Control meetings to help disseminate skills and tools developed to facilitate these processes. To facilitate the consistent and efficient submission of complete, accurate CTSA-related information to NCATS, the UC Davis CTSC proposes to hire and deploy a highly qualified person with the requisite skills and subject matter expertise to: 1) improve consistency of applications for prior approval; 2) develop systems to streamline collection and review of required compliance reports; and 3) manage and disseminate quality improvement tools to foster compliance with grant reporting.