Southern California Clinical and Translational Science Institute

摘要 南加州临床和转化科学研究所（SC CTSI）致力于确保安全， 高效率、高质量的研究来改善健康。作为常设委员会内部持续业务审查的一部分 CTSI，我们已经确定了获得NCATS批准进行涉及人类的研究的过程， 作为提高效率的重要机会。对这一进程的评估表明， 调查人员缺乏知识，没有一个人专门从事这一专门工作， 劳动密集型过程造成了延误，从而减缓了整个转化研究。我们建议雇用一名 新的质量保证（QA）专家，专门负责人类受试者的事先批准过程， 相关培训和便利。该专家将（a）实施和维持一个精简的质量 与机构和联邦监管程序保持一致的保证和控制程序， （B）参与定期培训，以提高当地编写高质量 意见书。总体目标将是通过协商、进程和政策， 改进、沟通和培训。直接结果将是缩短临床激活时间 研究，更知情和更有效的合作减少风险工作人员队伍，并减少其他供应链部门的行政负担， CTSI工作人员、IRB和NCATS。长期的影响将是更多的试验成功完成，更快， 以及SC CTSI与我们的IRB、NCATS和其他中心更好的行政整合。创新 方法，例如在这种情况下使用改善方法和可扩展的项目管理工具， Monday.com将与NCATS QA/QC小组共享，以帮助提高整个 CTSA网络。

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.