EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI) is an established method of signal detection. The monitoring process is facilitated by statistical summaries of the information received for each “drug-event” combination over defined time periods.