- Is the trial objective to study the therapeutic, diagnostic or preventive effect of one or more medicinal products?
- Is the trial objective to identify or investigate adverse reactions from one or more medicinal products?
- Is the trial objective to study the pharmacological effect (pharmacodynamics) of one or more medicinal products?
- Is the trial objective to study the absorbtion, distribution, metabolism or excretion (pharmacokinetics) of one or more medicinal products?
If the answer is yes to any of the four questions above, your trials falls under the definition of a clinical trial. Therefore, a clinical trial application must be submitted to the Icelandic Medicines Agency – unless your trial is a non-interventional study.
Further information is available in volume 10 - Guidance documents applying to clinical trials.