protocol
as defined in Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16…, Article 2(2), point (22) (Definitions)
a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial. The term ‘protocol’ encompasses successive versions of the protocol and protocol modifications
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Also defined in
- Regulation (EU) 2024/590 of the European Parliament and of the Council of 7 February 2024 on substances that deplete… 32024R0590, Article 3, point (3)
1987 Montreal Protocol on Substances that Deplete the Ozone Layer - Regulation (EU) 2024/573 of the European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse… 32024R0573, Article 3, point (7)
1987 Montreal Protocol on Substances that Deplete the Ozone Layer - Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws… 32001L0020, Article 2, point (h)
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;