ICH E2F Development safety update report - Scientific guideline

This document proposes a common standard for periodic reporting on drugs under development among the ICH regions - the development safety update report (DSUR). It defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.

Keywords: Development safety update report (DSUR), active substance, periodicity, data lock point, combination therapies, reference safety information, clinical trials, cumulative subject exposure, line listings, new safety data, non-clinical data, literature, lack of efficacy, late-breaking information, benefit-risk