The goal of this study was to develop template protocols for four different safety monitoring designs: (1) cohort event monitoring to assess safety, (2) rapid assessment of safety concerns through electronic health records, (3) safety evaluation of COVID-19 vaccines through electronic health records, and (4) hospital case–based monitoring of specific adverse events. These templates should be treated as a baseline and require further finalisation by the end user.
Part of a Larger Initiative
This study is part of the ACCESS project.
Learn more about the ACCESS project