title: [How to establish GCP-units in Denmark?].
abstract: According to a new EU Directive investigator initiated drug trials are to comply with the guidelines for Good Clinical Practice (GCP) as of May 2004. This implies that trials should be conducted according to a set of Standard Operating Procedures (SOPs) and be subject to monitoring and auditing. In 2001, investigators in Denmark initiated 73 drug trials. In order to provide GCP services and guidance to the investigators it is proposed to establish 3-4 regional GCP units at the three university hospitals. The estimated annual cost for the 3-4 GCP units will be between DDK 7.5 and 10 million.
authors.affiliation: Klinisk Forskningsenhed, H:S Hvidovre Hospital, Afsnit 136, DK-2650 Hvidovre. kim.krogsgaard@hh.hosp.dk
authors.forename: Kim
authors.initials: K
authors.lastname: Krogsgaard
authors.forename: Per Buch
authors.initials: PB
authors.lastname: Andreasen
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards; D003718:Denmark; D016903:Drug Monitoring / Q000592:standards; D005062:European Union; D017408:Guidelines as Topic; D006785:Hospitals, University / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007258:Informed Consent; D017410:Practice Guidelines as Topic; D012106:Research / Q000331:legislation & jurisprudence / Q000592:standards; D035842:Research Subjects / Q000331:legislation & jurisprudence