Article 59 sets the informed-consent requirements for performance studies (parallel to CTR Article 29): written + dated + signed by the subject or legal representative, after receiving comprehensive information, freely given, revocable. Article 60 sets protection of incapacitated subjects. Article 61 sets protection of minors. Article 62 governs emergency-situation performance studies with deferred consent.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.