EMA: Draft guideline on detection and management of duplicate individual cases and individual case safety reports (ICSRs)

Duplicate cases can pose significant problems for analysing signals arising from pharmacovigilance databases, both artificially inflating and masking signals of disproportionate reporting. The current reporting rules guarantee duplicate reporting. Databases should be routinely screened to detect and eliminate duplicate cases. This guideline proposes methods for detecting, confirming and managing duplicate cases suitable for organisations receiving pharmacovigilance data in various different formats.