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.

项目总结/摘要 美国国立卫生研究院（NIH）国家转化科学推进中心（NCATS）的目标是 就是让更多的人更快地得到更多的治疗。然而，新墨西哥州的许多大学（UNM） 临床和转化科学中心（CTSC）的活动，特别是试点赠款和KL 2学者项目， 要求NIH事先批准，涉及非常具体的提交程序，如果不精确执行， 可能导致研究启动延迟。为了解决这个问题，聘请全职质量保证/质量控制 (QA/QC）经理。长期目标是提供持续、健壮和高效的连续 提高联合国墨西哥城技术服务中心的业务质量以及与国家技术援助中心的所有互动。目标是 提高CTSC向NCATS提交的所有材料的质量和效率。理由是，协调 CTSC与NCATS的活动对于实现NIH的优先事项和加强临床和 翻译研究（CTR）本地，区域和国家。这一目标将通过两个方面来实现。 具体目标：1）提高向委员会提交的CTSA要求的信息的质量、一致性和效率， NCATS和eRA人类受试者系统，建立一个新的单一联络点; 2）通过认真的、有针对性的改进， 评估与NCATS提交相关的成果指标，领导有针对性的精益项目，教育 中心调查员和工作人员的培训，以及分享最佳做法。根据第一个目标，QA/QC经理将 聘用和定向，对影响当前提交的因素进行评估，制定全面的 用于事先批准的QA/QC系统，包括调整或开发模板、检查表、工作流程图， 和标准操作程序;并积极参与NCATS QA/QC讨论论坛和其他 财团团体。根据第二个目标，管理人将跟踪和评估NCATS的成功 提交;进行有针对性的精益活动，以持续提高质量，一致性和效率， 提交;为CTSC教职员工制定与事先批准相关的教育计划;并分享 CTSA联盟的最佳实践。这种方法是创新的，因为责任分散 现在，四个职位的工作将由一名经理执行，他将与CTSA密切合作 联合体使用最佳实践设计、实施和评估改进的提交。拟议 这一立场意义重大，因为它将减轻NCATS和CTSC的行政负担， 将CTR转化为临床和公共卫生实践。