Updated 12 June 2012
Investigating the efficacy and side effects of medicines
Clinical trials are undertaken to find out how medicine works, what side effects it causes and how it is metabolised in the body. Trials are conducted on new medicines as well as medicines that are already on the market in Denmark.
Medicine is tested on volunteers
Clinical trials are conducted on healthy volunteers or patient volunteers. Anyone participating in a clinical trial must receive both written and oral information about the trial, and participants must give their consent before the trial starts.
Clinical trials must be approved
In Denmark, clinical trials must be notified to the Danish Health and Medicines Authority by the person, individual or group that takes overall responsibility for the trial (the sponsor), but a doctor or dentist (the investigator) must always participate in the conduct of the trial.
The Danish Health and Medicines Authority evaluates both the quality of the investigation and the patient safety of clinical trials.
In Denmark, clinical trials must also be notified to a research ethics committee, which performs an overall assessment of the trial's ethical aspects. Before a clinical trial can be started, approvals must be obtained from both a research ethics committee and the Danish Health and Medicines Authority.
Report adverse reactions in clinical trials (SUSAR)
Report adverse reactions in clinical trials
Application to conduct a clinical trial
Guidelines and forms for application to conduct a clinical trial as well as notification of amendments to an already authorised clinical trial can be found in the menu to the left. Here you can also find information about assessment times and fees and go to other information on clinical trials.
Clinical trial inspection
The Danish Health and Medicines Authority performs inspections of clinical trials to ensure compliance with the standards of good clinical practice, GCP. We inspect clinical trials both in Denmark and abroad. This includes inspections coordinated by the European Medicines Agency (EMA).
Information about clinical trial inspection
Questions and answers about clinical trials
If you are not sure whether or not your clinical trial needs to be notified to the Danish Health and Medicines Authority, please read our questions and answers about clinical trials.
Clinical investigations of medical devices
Information about clinical investigations of medical devices.