Article 52 requires the sponsor to notify the Member States concerned within 7 days of a serious breach of the Regulation or the version of the protocol applicable at the time of the breach. A 'serious breach' is one likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated by the trial.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.