Commission Directive 2005/28/EC of 8 April 2005 laying down… Article 4

Article 4

The protocol referred to in point (h) of Article 2 of Directive 2001/20/EC shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy. The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial.

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Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 4 of Commission Directive 2005/28/EC of 8 April 2005 laying down… (LawPlayer, data as of 2026-07-04)

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