QAQC Johns Hopkins Institute for Clinical and Translational Research

QAQC 约翰霍普金斯临床与转化研究所

• 批准号: 10158890
• 负责人: Daniel Ernest Ford
• 金额: $ 18.19万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10158890
• 关键词: Adherence; Administrative Supplement; Area; Award; Clinical Research; Data; Ensure; Human Resources; Institutes; Institution; Maryland; Policies; Positioning Attribute; Process; Quality Control; Research; System; Translational Research; United States National Institutes of Health; Universities; Work; cohesion; human subject; improved; programs; quality assurance

The objective of this Administrative Supplement for a Quality Assurance/Quality Control position is to ensure high quality submissions to the NCATS prior approval process. The specific aims are as follows: 1) Ensure adherence to NIH and NCATS policies regarding CTSA-related submissions to NCATS and submissions to the eRA Human Subjects System, and participate in process improvement across the CTSA consortium. 2) Improve the quality of the prior approval submissions across all partner institutions for Pilot awards and KL2 projects by reducing inaccurate information and incomplete submissions 3) Implement a formal quality review process prior to submission to NCATS. 4) Develop a centralized management process for submissions to the eRA Human Subjects System to ensure consistency, accuracy, and efficiency. 5) Review and compile data on any problem submission areas and develop corrective action plans. This will be accomplished by having a dedicated Research Navigator who will ensure these specific aims are implemented and followed not only at Johns Hopkins (JH) but at partner institutions also. To ensure consistency across JH and University of Maryland, the Research Navigator position will be split between the two institutions 75% and 25%, respectively, to allow for a well-coordinated, cohesive, high-quality process.

质量保证/质量控制职位的行政补充的目的 是为了确保高质量的提交给NCATS事先批准过程。具体目标 如下所示： 1)确保遵守NIH和NCATS关于CTSA相关提交的政策， NCATS和向eRA人类受试者系统提交，并参与 CTSA联盟的流程改进。 2)提高所有伙伴机构提交的事先批准文件的质量， 通过减少不准确的信息和不完整的信息， 划界案 3)在提交给NCATS之前实施正式的质量审查流程。 4)为向eRA Human提交文件制定集中管理流程 主题系统，以确保一致性，准确性和效率. 5)审查和汇编任何问题提交领域的数据，并制定纠正措施 行动计划。 这将通过有一个专门的研究导航谁将确保这些 具体的目标不仅在约翰霍普金斯（JH），而且在合作伙伴 机构也。为了确保JH和马里兰州大学的一致性，研究 领航员职位将在两个机构之间分别分配75%和25%，以允许 一个协调良好、有凝聚力、高质量的过程。