Article 94 requires Member States to lay down penalties applicable to infringements of the Regulation, including (a) compliance with the conditions on subject protection and informed consent; (b) compliance with the conditions on safety reporting; (c) compliance with the conditions on the conduct of the trial; (d) other relevant provisions. The penalties must be effective, proportionate and dissuasive.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.