title: Re-engineering the European Union Clinical Trials Directive.
authors.affiliation: Central Committee on Research Involving Human Subjects, The Hague, the Netherlands.
authors.forename: M J H
authors.initials: MJ
authors.lastname: Kenter
authors.forename: A F
authors.initials: AF
authors.lastname: Cohen
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research / Q000458:organization & administration*; D005060:Europe; D005062:European Union; D006801:Humans; D017410:Practice Guidelines as Topic