CTSA Administrative Supplement for Quality Assurance/Quality Control Position

项目摘要 本申请是作为对NOT-TR-20-014的回应而提交的，作为家长奖的补充 UL 1 TR 002489，北卡罗来纳州转化和临床科学研究所（NC TraCS）。这个CTSA 行政补充将为NC增加一个专门的质量保证/质量控制职位 TraCS监管知识和支持计划，以执行CTSA相关的质量审查 向NCATS提交，向eRA人类受试者系统提交，以及管理 事先批准程序。本补编将处理以下具体目标： 目标1 -设立一个专门的职位，监督和管理内部流程，以便事先批准 要求NCATS。 目标2 -执行全面评价战略，以指导决策并确保 流程的持续改进。

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.