CTSA Administrative Supplement for Quality Assurance/Quality Control Position

点击翻译按钮获取中文摘要

Project summary This application is submitted in response to NOT-TR-20-014 as a supplement to Parent Award UL1TR002489, the North Carolina Translational and Clinical Sciences Institute (NC TraCS). This CTSA Administrative Supplement will add a dedicated quality assurance/quality control position to the NC TraCS Regulatory Knowledge and Support Program to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall prior approval process. The following specific aims will be addressed by this supplement: Aim 1 – Create a dedicated position to oversee and manage internal processes for prior approval requests to NCATS. Aim 2 – Implement a comprehensive evaluation strategy to guide decision-making and ensure continuous improvement in processes.