title: [ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives].
abstract: Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conduction, recording and reporting trials that involve the participating of human subjects. Since 1997 the ICH-GCP Guideline has been a requirement for conducting clinical trials which should be used as documentation to the authorities. The 13 fundamental principles of the ICH-GCP Guideline for conducting clinical trials are described. Furthermore, the most essential responsibilities of the investigator, sponsor and sponsor-investigator are mentioned. Investigator-initiated trials do not need to be conducted according to the GCP-principles but after the implementation of the EU Directive 2001/20/EC this will be changed. Today the GCP-principles only apply to clinical research with drugs but within a few years the GCP-principles will probably be a requirement for all clinical research.
authors.affiliation: AstraZeneca A/S, Roskildevej 22, DK-2620 Albertslund.
authors.forename: Ebbe
authors.initials: E
authors.lastname: Englev
authors.forename: Kurt Pfeiffer
authors.initials: KP
authors.lastname: Petersen
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D003718:Denmark; D017277:Drug Approval; D016903:Drug Monitoring / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent; D007391:International Cooperation; D011785:Quality Assurance, Health Care; D012108:Research Personnel / Q000592:standards; D035842:Research Subjects; D012109:Research Support as Topic