[The GCP directive--consequences for clinical drug research].
The contents and implications of the EU Directive on good clinical (research) practice (GCP) regarding drug trials are described. As of May 2003, clinical researchers in Denmark must have standard operation procedures, conduct monitoring, consider quality assurance, and expect inspections. The industry may be better prepared, but the Directive makes GCP part of the law and phase IV studies become subject to GCP. Patients will be assured the same quality in trials irrespective of the industry or investigator being the sponsor and may look forward to quality improvement of drug trials.
Gluud
Christian N
CN
Copenhagen Trial Unit, Center for Klinisk Interventionsforskning, Afsnit 7102, H:S Rigshospitalet, Blegdamsvej 9, DK-2100 København ø. cgluud@ctu.rh.dk
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D017327:Clinical Trials, Phase IV as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D003718:Denmark; D017277:Drug Approval / Q000331:legislation & jurisprudence; D016903:Drug Monitoring / Q000592:standards; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards*