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

项目概要/摘要 本行政补充说明了为UC提供详细监管协助的员工职位 戴维斯临床和转化科学中心（CTSC）。具体而言，这一新职位将协助反恐委员会 准备和跟踪迟发性人类受试者研究的申请。当由 美国国立卫生研究院（NIH）国家转化科学推进中心（NCATS），人类 受试者的研究在赠款资助的项目开始之前需要得到该机构的审查和批准。这 事先批准过程与临床和翻译资助的试点奖和KL 2项目很常见 科学奖（CTSA）。开发需要事先批准的应用程序需要 关键信息的收集、汇编、组织和提交到联邦系统中。确保这些 申请书是否完整、准确并准备好进行审查是一项复杂而耗时的任务。 此外，NIH要求联邦资助的研究成果的出版物符合公众要求。 访问政策。这一持续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。 这些步骤对于作者来说并不总是那么简单，而且往往需要家长付出很大的努力 提供联邦资金的获奖者。这项工作的详细性质与技能很好地结合起来 管理事先批准申请。 这两项责任对于成功的CTSA都是必不可少的，如果不能有效和一致地履行， NCATS工作人员浪费时间的可能性很大， 开始研究并获得年度资助。被雇来承担这些责任的人 将在反恐安全委员会中承担责任，接受有关机构和联邦的培训，并熟悉这些培训 系统，并将发挥关键作用，与CTSC转化研究合规委员会。必要的 技能和责任将产生良好的集成，充分准备和高度兼容的应用程序， 向NCATS报告。这一专门的个人也将能够参与NCATS质量保证和 质量控制会议，以帮助传播技能和工具，以促进这些进程。 为了促进一致和有效地向CTSA提交完整、准确的相关信息， NCATS，加州大学戴维斯分校CTSC建议雇用和部署一个具有必要技能的高素质人员， 主题专门知识：1）提高申请事先批准的一致性; 2）开发系统， 简化所需合规报告的收集和审查; 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.