Electronic adverse event reporting
This article was originally published in The Gray Sheet
Executive Summary
NIH Director Elias Zerhouni, MD, highlights recent collaboration between FDA and NIH to establish uniform electronic adverse event reporting during a March 25 House Energy & Commerce Health Subcommittee hearing. "We want it reported in one database, so that FDA and ourselves can immediately find out what is harmful in any one trial that we do," the director states. The agencies will implement electronic adverse event reporting in gene research transfer through the Genetic Modification Clinical Research Information System (GeMCRIS)...