Improvement of AE monitoring

Beth Israel Deaconess Medical Center, Boston MA

Investigators

Abstract

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