Washington University Institute of Clinical and Translational Sciences

华盛顿大学临床与转化科学研究所

• 批准号: 10700256
• 负责人: William G. Powderly
• 金额: $ 5.4万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-21 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10700256
• 关键词: Acceleration; Administrative Supplement; Advocate; Affect; Award; Biometry; Clinical Research; Clinical Sciences; Clinical and Translational Science Awards; Collaborations; Communities; Community Health; Complex; Cost Sharing; Data Set; Decision Making; Dedications; Documentation; Ecosystem; Effectiveness; Electronic Mail; Ensure; Evaluation; Faculty; Funding; Goals; Grant; Health; Healthcare Systems; Home; Human Resources; Human Subject Research; Illinois; Individual; Informatics; Institution; Interdisciplinary Study; Life; Longevity; Mentors; Methods; Missouri; Multicenter Trials; National Center for Advancing Translational Sciences; Notification; Outcome; Parents; Participant; Patients; Pilot Projects; Population; Population Heterogeneity; Positioning Attribute; Process; Productivity; Qualifying; Quality Control; Research; Research Personnel; Role; Rural Population; Science; Special Population; Specific qualifier value; System; Technology; Time; Training Programs; Translating; Translational Research; Translations; United States National Institutes of Health; Universities; Urban Population; Washington; Work; Workforce Development; archived data; clinical application; community engaged research; digital; diverse data; education research; health disparity; human subject; implementation design; implementation science; improved; innovation; interoperability; multidisciplinary; novel; population health; programs; quality assurance; response; translational impact

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.

项目概要 本申请是针对 NOT-TR-20-014 提交的，作为家长奖 UL1TR002345 的补充， 华盛顿大学临床与转化科学研究所 (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)。这个要求 适用于由 CTSA 赠款资金或自愿承诺成本分摊直接支持的试点项目，以及 涉及高铁的 KL2 学者项目。这些研究与 NCATS 指定的一起进入 HSS 项目开始之前需要提供文档和电子邮件通知。 本 CTSA 行政补充文件的总体目标是添加专门的质量保证/质量 WU ICTS 行政核心的控制地位。他们的职责是与 KL2 协调和协作 学者和试点 PI 有关向 NCATS 提交 CTSA 相关材料、向 HSS 提交材料以及 管理整个事先审批流程。具体目标如下。 目标 1：QA/QC 人员将监督和管理人体受试者研究 (HSR) 的内部流程 事先批准请求，以促进一致性和效率，并促进成功提交 发送至 NCATS 的 CTSA 相关信息包。 目标2：QA/QC人员将实施全面的评估策略来指导决策和 确保流程的持续改进。