EU Clinical Trials Regulation (CTR 536/2014)
CTR - Authorisation Procedure and Substantial Modifications (Ch II-III)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.10: Specific considerations for vulnerable populations (Article 10)

Article 10 requires specific consideration for vulnerable populations during assessment: women of childbearing potential / pregnant or breastfeeding women, persons unable to give informed consent, minors, and persons in emergency situations. The protocol must justify their inclusion, the risk-benefit balance and the safeguards employed.

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