title: [The role of the Danish Medical Products Agency in clinical trials].
abstract: The registration and legislation concerning clinical trials are described with specific focus on subjects of importance to Danish doctors. Especially the investigators' responsibility for the registration of the trial, reporting of serious adverse events and final report to the agency are mentioned. The fact that the evaluation of a protocol will focus on the risk, the contents of essential new knowledge and the design are emphasised. The process of approval and the fees are mentioned, and finally the changes caused by the new GCP-directive are discussed.
authors.affiliation: Laegemiddelstyrelsen, Sektion for Kliniske Forsøg, Inspektionen. acsi@dadlnet.dk
authors.forename: Anne Catrine
authors.initials: AC
authors.lastname: Simonsen
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003718:Denmark; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods / Q000458:organization & administration*; D016903:Drug Monitoring; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational; D005062:European Union; D006077:Government Agencies; D017408:Guidelines as Topic; D006801:Humans; D028701:Patient Rights / Q000331:legislation & jurisprudence; D010819:Physician's Role; D017410:Practice Guidelines as Topic
chemical_list: D015507:Drugs, Investigational