EU Clinical Trials Regulation (CTR 536/2014)
CTR - Sponsor, Damage Compensation and Supervision (Ch XI-XIII)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.76: Damage compensation (Article 76)

Article 76 requires Member States to ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical trial are in place in the form of insurance, guarantee or similar arrangement. Member States are entitled to operate a national indemnification mechanism for low-intervention clinical trials (or other-than-low-intervention trials where Member State law so provides).

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