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.

项目概要/摘要 美国国立卫生研究院 (NIH) 国家转化科学促进中心 (NCATS) 的目标 是为了更快地为更多的人提供更多的治疗 然而，新墨西哥大学 (UNM) 的许多人。 临床和转化科学中心 (CTSC) 的活动，特别是试点资助和 KL2 学者项目， 需要 NIH 事先批准，其中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，需要聘请全职质量保证/质量控制人员。 (QA/QC) 经理提出的长期目标是提供连续、稳健、高效的连续性。 提高 UNM CTSC 的运营以及与 NCATS 的所有互动的质量。 提高所有 CTSC 向 NCATS 提交的质量和效率 其理由是协调 CTSC 与 NCATS 的活动对于实现 NIH 优先事项以及加强临床和治疗至关重要 地方、区域和国家层面的转化研究（CTR） 该目标将通过两个目标来实现。 具体目标： 1) 提高提交至 CTSA 所需信息的质量、一致性和效率 NCATS 和 eRA 人类受试者系统，通过创建新的单点接触位置； 2) 提高 UNM CTSC 的能力，通过仔细的研究进行持续的、基于数据的改进 评估与 NCATS 提交、目标精益项目的领导力、教育相关的成果指标 中心研究人员和工作人员的参与，以及分享最佳实践，第一个目标是 QA/QC 经理。 雇用和导向，对影响当前提交的因素进行评估，制定全面的 用于事先批准的 QA/QC 系统，包括调整或开发模板、清单、工作流程图、 和标准操作程序；并积极参与 NCATS QA/QC 讨论论坛等 根据第二个目标，管理机构将跟踪和评估 NCATS 的成功。 提交；开展有针对性的精益活动，不断提高质量、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计划； CTSA 联盟的最佳实践 该方法具有创新性，因为职责分散。 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内容的联盟。 这一立场意义重大，因为它将减轻 NCATS 和 CTSC 的行政负担，并提高速度 将 CTR 转化为临床和公共卫生实践。