Washington University Institute of Clinical and Translational Sciences

项目摘要 本申请是作为对母公司奖励UL 1 TR 002345的补充而响应NOT-TR-20-014提交的， 华盛顿大学临床和转化科学研究所（WU ICTS）。NCATS之前 临床和转化科学奖（CTSA）人类受试者研究（HSR）的审批流程 要求将研究信息输入NIH eRA人类受试者系统（HSS）。这一要求 适用于由CTSA赠款资助或自愿承诺费用分摊直接支持的试点项目， KL 2奖学金项目涉及高铁。将这些研究与NCAT规定的 在项目开始之前，需要文件和电子邮件通知。 本CTSA管理补充文件的总体目标是增加专门的质量保证/质量 控制位置到WU ICTS行政核心。他们的角色是与KL 2协调和合作 学者和试点PI关于向NCATS提交CTSA相关材料、向HSS提交材料，以及 这是一个全面的事前审批过程。具体目标如下。 目标1：QA/QC人员将监督和管理人类受试者研究（HSR）的内部流程 事先批准请求，以促进一致性和效率，并加强提交成功的 向NCATS提供与CTSA有关的信息包。 目标2：质量保证/质量控制人员将执行一项综合评价战略，以指导决策， 确保过程的持续改进。

PROJECT SUMMARY This application is submitted in response to NOT-TR-20-014 as a supplement to Parent Award UL1TR002345, the Washington University Institute of Clinical and Translational Sciences (WU ICTS). The NCATS prior approval process for Clinical and Translational Science Awards (CTSA) human subject research (HSR) requires study information to be entered into the NIH eRA Human Subjects System (HSS). This requirement applies to Pilot projects supported directly with CTSA grant funding or voluntary committed cost sharing and KL2 Scholar projects that involve HSR. The entry of these studies into the HSS along with NCATS-specified documentation and email notification are required before the project can begin. The overall goal of this CTSA Administrative Supplement is to add a dedicated Quality Assurance/Quality Control position to the WU ICTS Administrative Core. Their role is to coordinate and collaborate with KL2 Scholars and Pilot PIs regarding CTSA-related submissions to NCATS, submissions to the HSS, and management of this overall prior approval process. The specific aims are included below. Aim 1: QA/QC personnel will oversee and manage internal processes for human subjects research (HSR) prior approval requests to facilitate consistency and efficiency and enhance the submission of successful CTSA-related information packages to NCATS. Aim 2: QA/QC personnel will implement a comprehensive evaluation strategy to guide decision-making and ensure continuous improvement in processes.