Washington University Institute of Clinical and Translational Sciences

项目总结 本申请是对NOT-TR-20-014的响应，作为家长奖UL1TR002345的补充， 华盛顿大学临床与翻译科学研究所(WU ICTS)。NCATS之前的 临床和翻译科学奖(CTSA)人类主题研究(HSR)的审批程序 要求将研究信息输入NIH时代的人类受试者系统(HSS)。这一要求 适用于由CTSA赠款资金或自愿承诺费用分摊直接支持的试点项目，以及 涉及高铁的KL2奖学金项目。这些研究的条目与NCATS一起进入HSS-指定 在项目开始之前，需要文档和电子邮件通知。 本CTSA行政副刊的总体目标是增加专门的质量保证/质量 控制职位移交给WU ICTS管理核心。他们的角色是与KL2协调和合作 关于向NCATS提交与CTSA相关的意见书、向HSS提交意见书的学者和试点PI，以及 对整个事先审批流程的管理。具体目标如下。 目标1：QA/QC人员将监督和管理人体研究(HSR)的内部流程 事先批准的请求，以促进一致性和效率，并增强提交成功的 与CTSA相关的信息包发送到NCATS。 目标2：QA/QC人员将实施全面评估战略，以指导决策和 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 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.