EU Clinical Trials Regulation (CTR 536/2014)
CTR - Subject Protection and Informed Consent (Ch V)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.31_32: Trials on incapacitated subjects and minors (Articles 31-32)

Article 31 governs clinical trials on incapacitated subjects: trial must be essential with respect to the incapacitated population, expected benefits to the population must outweigh the risks, and consent is given by the legally designated representative with the subject's assent where possible. Article 32 governs clinical trials on minors: similar safeguards with assent of the minor where age-appropriate, and the protocol must contain specific provisions for the minor's age and maturity.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • IVDR-Art.59_60_61_62 Informed consent + protection of subjects + emergency situations (Articles 59-62)

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.

Other controls in CTR - Subject Protection and Informed Consent (Ch V)

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.