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.
This control maps to 3 controls across 2 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 3 it maps to, and the evidence behind each claim, over MCP and REST.