Pharmacovigilance Glossary Terms

SAFETY MANAGEMENT PLAN (SMP): It is the procedure created to regulate all safety communication between the Sponsor and the Contract Research Organizations (CROs).

This procedure ensures the safety reporting of serious adverse events to sites, institutional review boards (IRB) and competent authorities is performed correctly, timely and accordingly with the regulatory requisites.

It also ensures the integrity of the clinical study results and the use of the authorized medicinal products.