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.

这种行政补充的目的是质量保证/质量控制位置 是为了确保NCAT的高质量提交事先批准过程。具体目标 如下： 1）确保遵守有关CTSA相关提交的NIH和NCAT的政策 NCAT和提交人类主体系统的提交，并参与 整个CTSA联盟的过程改进。 2）提高所有合作伙伴机构的事先批准提交的质量 通过减少信息不准确和不完整，试点奖和KL2项目 提交 3）在向NCAT提交之前实施正式的质量审查过程。 4）开发一个集中的管理流程，以提交人类时代 受试者系统确保一致性，准确性和效率。 5）查看和编译有关任何问题提交领域的数据并开发纠正措施 行动计划。 这将通过拥有专门的研究导航器来实现，以确保这些导航器 实施具体目标，不仅在约翰·霍普金斯（JH），而且在合作伙伴中遵循 机构也是如此。为了确保JH和马里兰大学的一致性，研究 导航员位置将分别分别在两个机构之间，分别为75％和25％，以允许 用于协调良好，凝聚力，高质量的过程。