(h)

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use · European Union

‘protocol’: a document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments;

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Source: EUR-Lex (Cellar) · retrieved 2026-11-03 · Text as adopted (Official Journal); later amendments are not incorporated in this text.