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

点击翻译按钮获取中文摘要

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.