Southern California Clinical and Translational Science Institute

南加州临床与转化科学研究所

• 批准号: 10700623
• 负责人: Thomas A Buchanan
• 金额: $ 4.99万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10700623
• 关键词: California; Clinical Research; Clinical Sciences; Communication; Consultations; Dedications; Ensure; Goals; Health; Individual; Institution; Institutional Review Boards; Knowledge; Methods; National Center for Advancing Translational Sciences; Outcome; Positioning Attribute; Process; Process Assessment; Quality Control; Research; Research Personnel; Specialist; Training; Translational Research; human subject; human subject protection; improved; innovation; process improvement; programs; quality assurance; tool

ABSTRACT The Southern California Clinical and Translational Science Institute (SC CTSI) is committed to ensuring safe, efficient, and high-quality research to improve health. As part of ongoing operational review within the SC CTSI, we have identified the process of obtaining NCATS approval to conduct research involving human subjects as an important opportunity for enhancing efficiency. Assessment of this process has revealed that lack of knowledge on the part of investigators and lack of a single individual dedicated to this specialized and labor-intensive process contribute to delays, which slow translational research overall. We propose to hire a new Quality Assurance (QA) Specialist who will specialize in the human subjects' prior approval process and associated training and facilitation. The Specialist will (a) implement and maintain a streamlined quality assurance and control program that is aligned with institutional and federal regulatory processes for human subject protections and (b) engage in regular training to increase local capacity for preparing high-quality submissions. The overarching goal will be to enhance efficiency and quality through consultations, process improvement, communication, and training. The immediate outcomes will be shorter activation times for clinical studies, a better informed and more efficient CTR workforce, and reduced administrative burdens on other SC CTSI staff, the IRBs and NCATS. The long-term impacts will be more trials completed successfully and faster, as well better administrative integration of the SC CTSI with our IRBs, NCATS and other hubs. Innovative approaches such as use in this setting of the Kaizen method and a scalable project management tool, Monday.com will be shared with the NCATS QA/QC group to help improve efficiency and quality across the CTSA network.

抽象的 南加州临床和转化科学研究所（SC CTSI）致力于确保安全， 高效和高质量的研究以改善健康。作为SC中正在进行的运营审查的一部分 CTSI，我们已经确定了获得NCAT批准的过程，以进行涉及人类的研究 受试者是提高效率的重要机会。对此过程的评估表明 研究人员缺乏知识，缺乏专门针对这一专业和专门的人 劳动密集型过程有助于延迟，从而减慢整体翻译研究。我们建议雇用 新的质量保证（QA）专家，他将专门研究人类受试者的事先批准程序和 相关的培训和促进。专家将（a）实施并保持精简的质量 保证和控制计划与人类的机构和联邦监管程序保持一致 主题保护和（b）进行定期培训，以提高当地准备高质量的能力 提交。总体目标是通过咨询提高效率和质量 改进，沟通和培训。直接结果将是临床的较短激活时间 研究，一个更好的知情，更有效的CTR劳动力，并减轻了其他SC的行政负担 CTSI员工，IRB和NCAT。长期影响将是成功，更快地完成的试验， 还可以更好地将SC CTSI与我们的IRB，NCAT和其他枢纽进行行政整合。创新的 在这种设置的Kaizen方法和可扩展项目管理工具中使用的方法， Noting.com将与NCATS QA/QC组共享，以帮助提高整个效率和质量 CTSA网络。