Human Subjects Research Enhancements at Harbor-UCLA REI

Harbor-UCLA REI人类受试者研究增强计划旨在通过改善数据收集和跟踪流程以及实施长期计划以确保REI IRB项目的认证，加强对Harbor-UCLA REI人类研究受试者的保护。具体而言，该方案确定了三个主要改进领域： (a)开发计算机跟踪人类受试者协议的基础设施/技术， 安全记录保留、电子协议提交。 (b)开发系统，允许对研究药物进行“从摇篮到坟墓”的监测， 校园 (c)实施认证制度，以确保继续遵守高标准的人体受试者监督 前两项改进将允许更密切地跟踪研究方案，包括监测研究药物。第一项改进还将允许IRB及其支持部门合规办公室自动执行一些必要但劳动力和时间密集型的操作，例如准备议程、会议记录和研究者备忘录，以及建立与研究中心的直接链接，以便真实的及时传达IRB决定和报告不良事件。第三个组成部分，通过启动定期认证，将允许IRB/合规操作不断升级并保持在行业标准水平，以保护人类研究志愿者。

The Human Subjects Research Enhancements at Harbor-UCLA REI program is intended to strengthen the protection of human research subjects at Harbor-UCLA REI by improving the data collection and tracking processes and by implementing a long term program to ensure accreditation of the programs of the IRB's at REI. Specifically, the program identifies three major areas for improvement: (a) Development of Infrastructure/technology for computer tracking of human subjects protocols, secure record retention, electronic protocol submission. (b) Development of system to permit the "cradle to grave" monitoring of investigational drugs on campus (c) Implementation of an accreditation system to ensure continuing adherence to high standards of human subjects oversight The first two enhancements will permit closer tracking of research protocols, including monitoring investigational drugs. The first enhancement will also permit the IRB's and their support arm, the Compliance Office, to automate a number of essential but labor- and time-intensive operations, such as preparation of agendas, minutes and investigator memos, as well as establishing a direct link to the study sites for real time communication of IRB decisions and reporting of adverse events. The third component, by initiating regular accreditation, will permit the IRB/Compliance operations to be continually upgraded and maintained at the industry standard level for protection of human study volunteers.