Article 43 requires the sponsor to submit annually to the Agency, for each IMP, an annual safety report (development safety update report, DSUR) for the duration of the clinical trial. The report is submitted via EudraVigilance and contains a summary and critical assessment of all relevant new safety information.
This control maps to 2 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.