Article 29 sets the informed-consent rules. Consent must be: in writing, dated, signed; freely given after the subject has been informed of the nature, objectives, benefits, implications, risks and inconveniences of the trial; given without compulsion; revocable at any time without detriment. Article 29(2) requires that the information is comprehensive, concise, clear, relevant and understandable to a layperson and includes specific items listed in Article 29(2)(a)-(k). Subjects may request a copy. Article 29(5) governs the case where the subject is unable to read.
This control maps to 6 controls across 3 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 6 it maps to, and the evidence behind each claim, over MCP and REST.