Project Summary The Irving Institute for Clinical and Translational Research (Irving Institute) is home to Columbia University’s (CU) Clinical and Translational Science Award (CTSA) Program hub. Our vision is to transform the health and wellbeing of our communities in New York City, the nation, and the world. We aim to catalyze all phases of clinical and translational science (T0-T4), synergize with our partners and stakeholders, and integrate activities within our hub and across the national CTSA Program. As a comprehensive CTSA, we offer a broad array of support for trainees, scholars and investigators across our entire hub, which includes Columbia University, the Columbia University Irving Medical Center, the New York Psychiatric Institute, and New York Presbyterian Hospital. We seek to continuously create and refine innovations for an integrated research- and user-friendly translational research environment at our hub. Among our successful programs are TRANSFORM (TRaining And Nurturing Scholars FOr Research that is Multidisciplinary), our workforce development resource that oversees the Institutional Career Development (KL2) program, and the Pilot and Collaborative Studies Resource (PCSR), our pilot funding program. Both functions have built robust programs to provide innovative resources, and combined they support over twenty projects a year for junior investigators and collaborative translational research. However, these programs must also navigate the complex regulatory approvals needed to begin research studies. The requirement that new KL2 scholar projects and pilot projects receive prior approval from the National Center for Advancing Translational Science (NCATS) has resulted in numerous inefficiencies and delays. The goal of this supplement is to develop regulatory and administrative expertise and structures to better manage the prior approval process and accelerate the movement of discoveries through the translational pipeline toward improving health. To achieve this goal, we propose to 1. Develop a dedicated quality assurance/quality control (QA/QC) position to oversee management of prior approval requests to NCATS: 1.1. Develop and implement an efficient process to collect material for NCATS prior approval submissions and perform QA/QC reviews for UL1- and KL2-related NCATS submissions, 1.2. Develop trainings and tools to enhance the quality and efficiency of prior approval submissions to NCATS and obtain trainings from NCATS and CTSA consortium members to ensure ongoing compliance; 2. Demonstrate the effectiveness of new processes and tools in producing timely, high-quality submissions to NCATS and apply the data to support continuous improvement; and 3. Disseminate innovative QA/QC methods for the prior approval process across the CTSA Program consortium and adopt best practices from the QA/QC Group and consortium members. This project will improve the quality of our prior approval submissions, accelerate the start of important r...