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

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.33_34_35: Pregnant/breastfeeding subjects, additional national measures, emergency trials (Articles 33-35)

Article 33 governs clinical trials on pregnant or breastfeeding women. Article 34 permits Member States to maintain additional measures on persons performing military service / persons deprived of liberty / persons residing in institutions / pregnant women / breastfeeding women. Article 35 governs clinical trials in emergency situations (deferred consent procedure where the subject's clinical condition does not allow prior consent, subject to strict safeguards including subsequent confirmation by the subject or the legal representative).

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