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- Clinical_Trials_Directive abstract "The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonize the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.The Articles of the Directive:Scope (Directive does not apply to non-interventional trials).DefinitionsProtection of clinical trial subjectsClinical trials on minorsClinical trials on incapacitated adults not able to give informed legalEthics CommitteeSingle opinionDetailed guidanceCommencement of a clinical trialConduct of a clinical trialExchange of informationSuspension of the trial or infringementsManufacture and import of investigational medicinal productsLabellingVerification of compliance of investigational medicinal products with good clinical and manufacturing practiceNotification of adverse eventsNotification of serious adverse reactionsGuidance concerning reportsGeneral provisionsAdaptation to scientific and technical progressCommittee procedureApplicationEntry into forceAddresseesThe Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004.".
- Clinical_Trials_Directive wikiPageExternalLink clinical-trials.
- Clinical_Trials_Directive wikiPageID "7467736".
- Clinical_Trials_Directive wikiPageLength "2572".
- Clinical_Trials_Directive wikiPageOutDegree "25".
- Clinical_Trials_Directive wikiPageRevisionID "678778098".
- Clinical_Trials_Directive wikiPageWikiLink Adverse_event.
- Clinical_Trials_Directive wikiPageWikiLink Category:2001_in_law.
- Clinical_Trials_Directive wikiPageWikiLink Category:2001_in_the_European_Union.
- Clinical_Trials_Directive wikiPageWikiLink Category:European_Union_directives.
- Clinical_Trials_Directive wikiPageWikiLink Category:European_clinical_research.
- Clinical_Trials_Directive wikiPageWikiLink Category:Pharmaceuticals_policy.
- Clinical_Trials_Directive wikiPageWikiLink Clinical_trial.
- Clinical_Trials_Directive wikiPageWikiLink Directive_(European_Union).
- Clinical_Trials_Directive wikiPageWikiLink EC.
- Clinical_Trials_Directive wikiPageWikiLink EEC.
- Clinical_Trials_Directive wikiPageWikiLink EEC.
- Clinical_Trials_Directive wikiPageWikiLink EEC.
- Clinical_Trials_Directive wikiPageWikiLink EEC.
- Clinical_Trials_Directive wikiPageWikiLink Ethics_committee_(European_Union).
- Clinical_Trials_Directive wikiPageWikiLink EudraLex.
- Clinical_Trials_Directive wikiPageWikiLink European_Medicines_Agency.
- Clinical_Trials_Directive wikiPageWikiLink European_Parliament.
- Clinical_Trials_Directive wikiPageWikiLink European_Union.
- Clinical_Trials_Directive wikiPageWikiLink Good_Clinical_Practice_Directive.
- Clinical_Trials_Directive wikiPageWikiLink Good_clinical_practice.
- Clinical_Trials_Directive wikiPageWikiLink Good_manufacturing_practice.
- Clinical_Trials_Directive wikiPageWikiLink Investigators_brochure.
- Clinical_Trials_Directive wikiPageWikiLink Regulation_of_therapeutic_goods.
- Clinical_Trials_Directive wikiPageWikiLink Serious_adverse_event.
- Clinical_Trials_Directive wikiPageWikiLinkText "Clinical Trials Directive".
- Clinical_Trials_Directive subject Category:2001_in_law.
- Clinical_Trials_Directive subject Category:2001_in_the_European_Union.
- Clinical_Trials_Directive subject Category:European_Union_directives.
- Clinical_Trials_Directive subject Category:European_clinical_research.
- Clinical_Trials_Directive subject Category:Pharmaceuticals_policy.
- Clinical_Trials_Directive hypernym Directive.
- Clinical_Trials_Directive type Book.
- Clinical_Trials_Directive type Directive.
- Clinical_Trials_Directive type Law.
- Clinical_Trials_Directive comment "The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. ".
- Clinical_Trials_Directive label "Clinical Trials Directive".
- Clinical_Trials_Directive sameAs Q2151374.
- Clinical_Trials_Directive sameAs EG_über_die_Anwendung_der_guten_klinischen_Praxis.
- Clinical_Trials_Directive sameAs WE.
- Clinical_Trials_Directive sameAs m.0262np4.
- Clinical_Trials_Directive sameAs Q2151374.
- Clinical_Trials_Directive wasDerivedFrom Clinical_Trials_Directive?oldid=678778098.
- Clinical_Trials_Directive isPrimaryTopicOf Clinical_Trials_Directive.