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CTSA Administrative Supplement for Quality Assurance/Quality Control Position

CTSA 质量保证/质量控制职位行政补充

基本信息

批准号：
10158836
负责人：
John Bernard Buse
金额：
$ 9.71万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-03-30 至 2023-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10158836
关键词：
Address Administrative Supplement Animal Experimentation Area Award Clinical Research Clinical Sciences Communication Communities Complex Consultations Cost Sharing Data Decision Making Development Documentation Effectiveness Ensure Evaluation Extramural Activities Fostering Funding Goals Grant Health Human Human Subject Research Institutes Institution Knowledge Manuscripts Maps Measures Mentors North Carolina Parents Persons Pilot Projects Positioning Attribute Process Program Evaluation Quality Control Research Research Infrastructure Research Personnel Research Support Research Training Resources Science Services System Time Training Training and Education Translating Translational Research Translations Trust United States National Institutes of Health Universities Vertebrates Work base career catalyst clinical application human subject improved innovation member minimal risk programs quality assurance response supportive environment training opportunity

项目摘要

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.

项目概要本申请是针对 NOT-TR-20-014 提交的，作为家长奖的补充 UL1TR002489，北卡罗来纳州转化和临床科学研究所 (NC TraCS)。本次CTSA 行政补充文件将为 NC 添加专门的质量保证/质量控制职位 TraCS 监管知识和支持计划，用于执行 CTSA 相关质量审查向 NCATS 提交、向 eRA 人类受试者系统提交以及总体管理事先批准程序。本补充文件将解决以下具体目标：目标 1 – 创建一个专门职位来监督和管理内部流程以获得事先批准向 NCATS 提出请求。目标 2 – 实施综合评估策略以指导决策并确保流程的持续改进。