EU Clinical Trials Regulation (CTR 536/2014)
CTR - General Provisions (Ch I)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.2: Definitions (Article 2)

Article 2 supplies definitions, including 'clinical study', 'clinical trial', 'low-intervention clinical trial', 'non-interventional study', 'investigational medicinal product (IMP)', 'auxiliary medicinal product', 'sponsor', 'investigator', 'subject', 'informed consent', 'protocol', 'serious adverse event', 'serious adverse reaction', 'suspected unexpected serious adverse reaction (SUSAR)', and 'serious breach'.

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