1.

The application dossier for the authorisation of a clinical trial shall contain all required documentation and information necessary for the validation and assessment referred to in Chapter II and relating to: the conduct of the clinical trial, including the scientific context and arrangements taken, the sponsor, investigators, potential subjects, subjects, and clinical trial sites; the investigational medicinal products and, where necessary, the auxiliary medicinal products, in particular their properties, labelling, manufacturing and control; measures to protect subjects; justification as to why the clinical trial is a low-intervention clinical trial, in cases where this is claimed by the sponsor. The list of required documentation and information is set out in Annex I.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.