Electronic Research Submission at Washington Univ

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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.