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

在 UNM HSC 临床和转化科学中心建立质量保证/质量控制能力

• 批准号: 10381962
• 负责人: RICHARD S LARSON
• 金额: $ 11.71万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-14 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10381962
• 关键词: Address; Affect; Area; Award; Center for Translational Science Activities; Clinical; Clinical Research; Clinical Sciences; Collaborations; Data; Development; Diagnostic; Education; Environment; Evaluation; Event; Extramural Activities; Faculty; Funding; Generations; Goals; Grant; Health Priorities; Health Sciences; Institution; Lead; Leadership; Methods; Mission; Modeling; NCI Scholars Program; New Mexico; Outcome; Positioning Attribute; Procedures; Process; Productivity; Public Health; Public Health Practice; Quality Control; Research; Research Personnel; Research Project Grants; Research Support; Resources; Services; Speed; System; Technical Expertise; Technology; Testing; Therapeutic; Thinness; Time; Training; Translational Research; Underrepresented Populations; United States National Institutes of Health; Universities; Woman; Work; base; clinical center; clinical translation; design; human disease; human subject; improved; innovation; novel; operation; programs; quality assurance; success

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.

项目摘要/摘要 美国国立卫生研究院（NIH）国家前进的转化科学中心（NCATS）目标 是为了更快地为更多的人获得更多治疗。但是，新墨西哥大学的许多（UNM） 临床和转化科学中心（CTSC）的活动，尤其是试点赠款和KL2科学项目， 需要NIH事先批准，该批准涉及非常具体的提交程序 可能导致研究计划的延迟。为了解决这个问题，雇用全职质量保证/质量控制 （QA/QC）提出了经理。长期目标是提供连续，健壮，有效的连续 UNM CTSC运营以及与NCAT的所有相互作用的质量提高。目的是 提高所有CTSC提交NCAT的质量和效率。理由是 与NCAT的CTSC活动对于获得NIH的优先级和增强临床和 在本地，区域和全国范围内翻译研究（CTR）。目标将通过两个实现 具体目的：1）提高提交给CTSA的信息的质量，一致性和效率 NCAT和ERA人类受试者通过创建新的，单一接触的位置。 2）通过谨慎提高UNM CTSC进行连续，基于数据的改进的能力 评估与NCAT提交有关的结果指标，目标精益项目的领导，教育 枢纽调查人员和员工，以及最佳实践的共享。在第一个目标下，QA/QC经理将是 雇用和定向，对影响当前提交的因素进行评估，发展全面 QA/QC系统用于事先批准，包括适应或开发模板，清单，工作流程图， 和标准操作程序；并积极参加NCATS QA/QC讨论论坛和其他 财团群体。在第二个目标下，经理将跟踪和评估NCAT的成功 提交；进行有针对性的精益事件，以不断提高质量，一致性和效率 提交；为CTSC的教职员工制定与先前批准有关的教职员工的教育计划；并分享 CTSA财团的最佳实践。这种方法是创新的，因为责任蔓延 现在，跨四个职位将由一位经理执行，他们将与CTSA密切合作。 使用最佳实践来设计，实施和评估改进提交的财团。提议 位置很重要，因为它将减少NCAT和CTSC的管理燃烧，并减少速度 将CTR转换为临床和公共卫生实践。