title: [Public GCP unit--experiences from the Aarhus University Hospital].
abstract: According to the EU GCP-directive, all clinical trials involving medical products must adhere to the GCP-standards by May 2004. This may entail difficulties for investigator-initiated trials not sponsored by the industry. A public GCP-unit was established at Aarhus University Hospital in 1995. The unit offers researchers a monitoring system including discussion of the protocol, check of formalities, and verification of data and protocol compliance. As a contribution to the future work with GCP, experience from the GCP-unit at Aarhus University Hospital is presented here.
authors.affiliation: GCP-enheden ved Arhus Universitetshospital, Bygning 1, Arhus Kommunehospital, Nørrebrogade 44, DK-8000 Arhus C. anjor@akh.aaa.dk
authors.forename: Annette
authors.initials: A
authors.lastname: Jørgensen
authors.forename: Inge-Lise Hassing
authors.initials: IL
authors.lastname: Rønnow
authors.forename: Ebba
authors.initials: E
authors.lastname: Nexø
mesh_terms: D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D003718:Denmark; D016903:Drug Monitoring / Q000379:methods / Q000592:standards; D005062:European Union; D019983:Guideline Adherence; D006785:Hospitals, University / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards*; D006801:Humans; D008485:Medical Audit; D017410:Practice Guidelines as Topic; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards*