EVDAS is the analytical component of EudraVigilance used to support pharmacovigilance safety monitoring, particularly signal detection and evaluation of individual case safety report data.
What it provides
EVDAS includes outputs such as electronic reaction monitoring reports (eRMRs), line listings and individual case report forms. It also supports quantitative screening measures including the reporting odds ratio.
Relationship with EudraVigilance
EVDAS is not a separate source database. It analyses data held within the EudraVigilance ecosystem. Access and available functions depend on the user's regulatory role.