The National Cancer Institute (NCI) is embarking on an ambitious effort to fully and seamlessly integrate the caAERS safety reporting system within the NCI clinical trials IT enterprise, known as the Integrated Safety Reporting (ISR) system. The NCI has selected SemanticBits, LLC to architect, manage, and implement the caAERS integration efforts which are the centerpiece of this effort. In addition to designing and implementing robust technical solutions, this project will require SemanticBits to coordinate and lead efforts involving multiple stakeholders from several federal agencies, COTs vendors and contractors, and the cancer research community. SemanticBits efforts will be coordinated on achieving two project goals: 1) reduce redundant data entry required for safety reporting by seamlessly combining processes and multiple data sources through the use and enhancement of caAERS service APIs, and 2) eliminate over and under reporting of adverse events through the use of the caAERS Rules Engine. Upon completion of this project, the NCI will have a greatly improved safety monitoring process supporting all NCI sponsored clinical trials.