[ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives].
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.
Englev
Ebbe
E
AstraZeneca A/S, Roskildevej 22, DK-2620 Albertslund.
Petersen
Kurt Pfeiffer
KP
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