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.
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D004348:Drug Labeling / Q000592:standards; D015507:Drugs, Investigational / Q000592:standards*; D028744:Ethics Committees, Research; D005060:Europe; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007391:International Cooperation; D016743:Mental Competency; D033242:Minors
D015507:Drugs, Investigational