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

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.28: General rules on subject protection (Article 28)

Article 28(1) sets the cumulative conditions for any clinical trial: (a) the anticipated benefits to subjects or public health justify the foreseeable risks and inconveniences; (b) subjects are protected through the procedures in this Chapter; (c) the rights, safety, dignity and well-being of subjects prevail over all other interests; (d) the trial is designed to generate reliable and robust data; (e) any risk to subjects is mitigated to the maximum extent; (f) the protocol is approved; (g) subjects benefit from medical care without charge for direct trial-related procedures.

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

What else in your programme already covers this

This control maps to 4 controls across 4 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.56_57_58 Performance evaluation, performance studies and additional requirements (Articles 56-58)
  • MDR-Art.61_62 Clinical evaluation and clinical investigations general requirements (Articles 61-62)

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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)

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