Quality Assurance and Reporting

质量保证和报告

• 批准号: 10158702
• 负责人: FREDERICK Gerard MOELLER
• 金额: $ 11.78万
• 依托单位: VIRGINIA COMMONWEALTH 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10158702
• 关键词: Administrative Supplement; Annual Reports; Clinical; Clinical Research; Communities; Development; Education; Effectiveness; Ensure; Evaluation; Funding; Funding Opportunities; Goals; Human Resources; Human Subject Research; Individual; Industry; Infrastructure; Institution; Intention; Lead; Link; Pilot Projects; Positioning Attribute; Procedures; Process; Quality Control; Reporting; Research Personnel; Research Support; Structure; Translational Research; Work; clinical center; expectation; human subject; improved; parent grant; programs; quality assurance

Project Summary/Abstract A primary goal of the CTSA Program is to support research institutions to improve the efficiency, effectiveness, and reach of clinical translational research. However, the reality is there are administrative reporting and approval requirements related to conducting translational research. Such requirements include NCATS Prior Approval for activities such as changes in key personnel, requesting carryover funds, standard annual reporting, and human subjects Prior Approval for KL2 Scholars and for Pilot Projects. If administrative reporting requirements contain errors or incomplete material this process delays the conduct of clinical translational research. As such, it is necessary to ensure quality of our reporting and that we, as a hub, meet reporting expectations by NCATS. This administrative supplement will support a staff position with the intention of managing and ensuring quality assurance for reporting activities to NCATS. This position will work with the Director of Evaluation, PI/Director and Administrative Director in ensuring that reporting requirements are consistent, efficient and error free. The individual who fills the staff position will contribute to the development of procedures at our local CTSA hub and will share and disseminate processes and procedures work well to the CTSA network.

项目概要/摘要 CTSA 计划的主要目标是支持研究机构 提高临床转化研究的效率、有效性和范围。 然而，现实情况是存在行政报告和审批要求 与进行转化研究有关。此类要求包括 NCATS Prior 批准关键人员变动、请求结转资金等活动， 标准年度报告和人类受试者事先批准 KL2 学者和 试点项目。如果行政报告要求包含错误或不完整 材料这一过程延迟了临床转化研究的进行。因此，它是 确保我们的报告质量以及我们作为中心满足报告的要求是必要的 NCATS 的期望。 该行政补充将支持一个工作人员职位 管理和确保报告活动质量保证的意图 NCATS。该职位将与评估总监、PI/总监和 行政总监确保报告要求一致， 高效且无错误。填补该员工职位的个人将做出贡献 我们当地 CTSA 中心的程序开发，并将分享和 将运作良好的流程和程序传播到 CTSA 网络。