The monitoring of adverse events (AE's) is an important aspect in the protection of human subjects enrolled in research protocols. This has become a cumbersome problem given the large volume of AE's that must be reported to the IRB especially from industry initiated multicenter trials, the importance of communicating AE's related to a particular study agent/device to any investigator utilizing that agent, and resultant actions which may include protocol/consent modification or cessation of the study. Paramount to this process is the education of investigators.
Two aims are proposed: 1. Develop the computer-based technology to enhance the monitoring of AE's, resultant actions, and dissemination of information to other investigators and related studies 2. Expand the role of the GCRC-based Research Subject's Safety Office to non-GCRC studies to include the development of Data Safety Monitoring/AE reporting, use this as a tool for auditing, and provide education to investigators
