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Clinical trialsA clinical trial is an investigation of the effect of a medicinal product, the adverse reactions it causes and how it is converted in the body. The investigation can comprise both new medicinal products and known medicinal products, which are already on the market in Denmark.
Investigations are carried out on healthy, voluntary trial subjects or on voluntary patients. All persons participating in a clinical trial must be given both written and oral information about the trial, and they must consent to participating before they become part of the clinical trial. In Denmark, clinical trials must be notified to the Danish Medicines Agency by the person or organisation with the overall responsibility for the trial (the sponsor). In addition to the sponsor, the trial must also have a responsible doctor or dentist. The Danish Medicines Agency evaluates both the quality of the investigation and the patient safety of the clinical trial. Clinical trials must also be notified to a research ethics committee, which primarily evaluates the ethical aspects of the trial. Before a clinical trial may be initiated, both the research ethics committee and the Danish Medicines Agency must approve the trial. Final date for receipt of clinical trials applications before Christmas Changed definition of safe contraception in clinical trials Amendments to clinical trials Fees for clinical trials EU directive does not result in fewer clinical trials from independent researchers The EudraCT number must be specified on the payment of fees for clinical trials Use of waivers in connection with the inclusion of trial subjects/patients in clinical trials EMEAs guideline for first-in-man clinical trials Proposal for new guideline for first-in-man clinical trials Clinical trials of medicinal products The Commission's Question & Answers on Clinical Trial Documents Consultation on Draft guidance on specific modalities for non-commercial clinical trials The European Commission publishes Volume 10 – clinical trials Executive order on clinical trials on medicinal products for human use EudraCT - the Community Clinical Trial system |
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Last updated - 08.02.2010
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