Building Quality Assurance/Quality Control Capacity at the UNM HSC Clinical and Translational Science Center

项目摘要/摘要 美国国立卫生研究院(NIH)国家翻译科学推进中心(NCATS)的目标 是为了更快地为更多的人提供更多的治疗。然而，许多新墨西哥大学(UNM) 临床和转化科学中心(CTSC)的活动，特别是试点助学金和KL2奖学金项目， 要求NIH事先批准，涉及非常具体的提交程序，如果不严格执行， 可能会导致研究启动的延迟。为了解决这个问题，聘请全职质量保证/质量控制 (QA/QC)经理被提名。长期目标是提供持续、稳健和高效的连续 提高UNM CTSC的业务以及与NCATS的所有互动的质量。我们的目标是 提高提交给NCATS的所有CTSC的质量和效率。其基本原理是协调 CTSC与NCATS的活动对于实现NIH的优先事项和加强临床和 地方、地区和国家的翻译研究(CTR)。这一目标将通过两个途径实现 具体目标：1)提高提交CTSA所需信息的质量、一致性和效率 NCATS和时代人类科目系统通过建立一个新的、单一的接触点位置； 和2)通过谨慎的方式提高联合国反恐中心的能力，以实现持续的、基于数据的改进 评估与NCATS提交、目标精益项目的领导力、教育相关的结果指标 中心调查人员和工作人员之间的合作，以及分享最佳做法。根据第一个目标，将有一名QA/QC经理 招聘和定向，对影响当前提交的因素进行评估，制定全面的 用于事先审批的QA/QC系统，包括修改或开发模板、核对表、工作流程图、 和标准操作程序；并积极参加NCATS QA/QC论坛等 财团集团。在第二个目标下，经理将跟踪和评估NCATS的成功 提交；开展有针对性的精益活动，以持续提高质量、一致性和效率 提交材料；为CTSC教职员工制定与事先批准相关的教育倡议；以及分享 与CTSA联盟的最佳实践。这种方法是创新的，因为责任分散了 四个职位现在将由一名经理执行，该经理将与CTSA密切合作 使用最佳实践设计、实施和评估改进的提交文件的联盟。建议数 这一职位意义重大，因为它将减轻NCATS和CTSC的行政负担，并加快 将CTR转化为临床和公共卫生实践。

PROJECT SUMMARY/ABSTRACT The National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences’ (NCATS) goal is to get more treatments to more people more quickly. However, many of the University of New Mexico (UNM) Clinical and Translational Science Center’s (CTSC) activities, especially pilot grants and KL2 scholar projects, require NIH prior approvals that involve very specific submission procedures that, if not implemented precisely, can lead to delays in study initiation. To address this, the hiring of a full time Quality Assurance/Quality Control (QA/QC) Manager is proposed. The long-term goal is to provide continual, robust, and efficient continuous quality improvement in the operations of the UNM CTSC and all interactions with NCATS. The objective is to improve the quality and efficiency of all CTSC submissions to NCATS. The rationale is that coordination of CTSC activities with those of NCATS is critical for achieving NIH priorities and enhancing clinical and translational research (CTR) locally, regionally, and nationally. The objective will be achieved through two specific aims: 1) Improve the quality, consistency and efficiency of CTSA-required information submitted to NCATS and the eRA Human Subjects System through the creation of a new, single point-of-contact position; and 2) Increase the capacity of the UNM CTSC for continuous, data-based improvement through careful evaluation of outcome metrics related to NCATS submissions, leadership of targeted Lean projects, education of hub investigators and staff, and sharing of best practices. Under the first aim, a QA/QC Manager will be hired and oriented, conduct an assessment of factors affecting current submission, develop a comprehensive QA/QC system for prior approvals including adapting or developing templates, checklists, workflow diagrams, and standard operating procedures; and actively participate in the NCATS QA/QC Discussion forum and other Consortium groups. Under the second aim, the Manager will track and evaluate the success of NCATS submissions; conduct targeted Lean events to continuously improve the quality, consistency, and efficiency of submissions; develop educational initiatives for CTSC faculty and staff related to prior approvals; and share best practices with the CTSA Consortium. The approach is innovative because the responsibilities spread across four positions will now be executed by one manager, who will work in close collaboration with the CTSA Consortium to design, implement, and evaluate improved submissions using best practices. The proposed position is significant because it will reduce administrative burden for both NCATS and the CTSC, and speed translation of CTR into clinical and public health practice.