Electronic Research Submission at Washington Univ

该项目的总体目标是为随后开发的总体电子提交基础设施奠定基础，以跟踪和存储华盛顿大学（WU）（包括其医学和学术校园）的所有人类受试者研究。 具体而言，本项目将开发：1）用于注册和认证研究者和支持人员的数据库，2）与该数据库的电子链接，以验证研究者已完成与人类受试者研究相关的法规要求和伦理问题的必要教育，以及3）用于评价严重不良事件报告的电子筛选工具。 WU的长期目标是开发机密的电子提交和存储： 首次和持续应用、修订、修正和严重不良事件报告（2001年记录的此类行动16 298起）; - 与研究者及其研究人员的所有书面（和口头）通信记录; - 跟踪和监测数据监测委员会报告; - 在线检索只读协议和经批准的同意文件; - 所有成员数据（注册、培训、向OHRP报告等）;并且，在本发明中， - 与多个IRB相关的活动（目前有10个正式委员会和4个小组委员会）。 此外，该基础设施将使所有合规委员会能够共享数据，以确保最高水平的人类受试者保护。

The overall goal of this project is to establish a foundation for the subsequent development of a total electronic submission infrastructure to track and store all human subject research at Washington University (WU) including its medical and academic campuses. Specifically, this project will develop: 1) a database for registering and authenticating investigators and support staff, 2) an electronic link to this database to provide verification that investigators have completed required education regarding regulatory requirements and ethical issues associated with the conduct of human subject research, and, 3) an electronic screening instrument to evaluate serious adverse event reports. WU's long-term goal is to develop confidential electronic submission and storage for: initial and continuing applications, revisions, amendments, and serious adverse event reports (16,298 such recorded actions in 2001); - all written (and log of oral) communications with investigators and their research staff; - tracking and monitoring Data Monitoring Committee reports; - on-line retrieval of read-only protocols and approved consent documents; - all membership data (crendentials, training, reports to OHRP, etc.); and, - activities associated with multiple IRBs (currently 10 full and 4 subcommittees). In addition, this infrastructure will make it possible for all compliance committees to share data to ensure the highest level of human subject protection.