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

关于设立专门 QAQC 人员以促进 CTSA 相关提交的一致性和效率的提案

• 批准号: 10601477
• 负责人: Theodore Wun
• 金额: $ 18.88万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10601477
• 关键词: Address; Administrative Supplement; Annual Reports; Award; Big Data; Biomedical Research; COVID-19; Center for Translational Science Activities; Clinical Sciences; Clinical and Translational Science Awards; Clinical effectiveness; Collection; Communities; Complex; Consumption; Development; Effectiveness; Elements; Enrollment; Ensure; Fostering; Funding; Future; Goals; Grant; Health; Human; Human Resources; Human Subject Research; Individual; Informatics; Intervention; Legal patent; Medicine; Methods; Mission; National Center for Advancing Translational Sciences; Nature; Office of Administrative Management; Opioid; Outcome; Pain; Parents; Pathway interactions; Patients; Persons; Pilot Projects; Play; Policies; Positioning Attribute; Preparation; Process; Publications; Quality Control; Race; Regulation; Reporting; Research; Research Personnel; Resources; Role; Rural Health; Science Policy; Services; Special Population; System; Time; Training; Translational Research; United States National Institutes of Health; Work; Workforce Development; clinical implementation; health equity; human subject; improved; innovation; meetings; member; programs; quality assurance; racism; skills; tool

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.

项目概要/摘要 本行政补充描述了向 UC 提供详细监管援助的工作人员职位 戴维斯临床和转化科学中心 (CTSC)。具体来说，这个新职位将协助 CTSC 准备和跟踪延迟发作人类受试者研究的申请。资助时 美国国立卫生研究院 (NIH) 国家转化科学促进中心 (NCATS)、人类 受试者的研究需要在拨款资助的项目开始之前得到该机构的审查和批准。这 事先批准流程与临床和转化资助的试点奖和 KL2 项目很常见 科学奖 (CTSA) 拨款。需要事先批准的应用程序的开发需要 收集、组装、组织关键信息并将其提交到联邦系统中。为了保证这些 申请完整、准确并准备好接受审查是一项复杂且耗时的任务。 此外，美国国立卫生研究院 (NIH) 要求联邦资助的研究成果发表的论文必须符合公众的要求 访问政策。这一持续的过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那么简单，而且通常需要家长付出巨大的努力 提供联邦资金的获奖者。这项工作的详细性质与技能非常吻合 管理事先批准申请所需的。 这两项职责对于 CTSA 的成功至关重要，如果不能有效、一致地履行， NCATS 工作人员很可能会浪费时间，从而导致延误 开始研究并收到年度资金。受雇承担这些工作的个人 职责将纳入 CTSC，接受培训并熟悉机构和联邦 系统，并将在 CTSC 转化研究合规委员会中发挥关键作用。必要条件 技能和责任将产生集成良好、准备充分且高度合规的应用程序和 向 NCATS 报告。该专职人员还将能够参与 NCATS 质量保证和 质量控制会议有助于传播为促进这些流程而开发的技能和工具。 促进一致、高效地提交完整、准确的 CTSA 相关信息 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能力的高素质人员 主题专业知识可以： 1) 提高事先批准申请的一致性； 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 改进工具以促进遵守拨款报告。