The Development Safety Update Report (DSUR) is a periodic reporting on drugs under development among the ICH (International Conference on Harmonisation - Europe, Japan and the United States) regions.
During the clinical development of an investigational drug, periodic analysis of safety information is crucial for assessing the risk of trial subjects. It is important to inform regulators at regular intervals about the results of such analysis and the evolving safety profile of an investigational drug, and apprise them of actions proposed or being taken to address safety concerns. Currently, laws and regulations of some ICH countries and regions require submission of a periodic report to regulatory authorities to provide this information.
ARISg supports the generation of DSUR from Reports menu and QBE. The application provides security privileges to control the generation of the report. ARISg provides the generation of DSUR in blinded and Unblinded format. Depending on the access privileges, you can generate the DSUR with Public and Private data.