Recapitulation of all local (country/site) safety reporting obligations.

This document gathers all local safety reporting requirements for the study from the various local Ethics Committees and local regulatory authorities. It is very helpful in an international multi-site study. If you plan a study with 1 site, it is probably not necessary to use this template as you can describe all the details of the process in the SOP (PV-001-CT) directly.

Target user: Sponsor and study site coordinator