Guide to assessing if a trial falls under the definition of a clinical trial

07 December 2011, Updated 15 June 2012

Is your trial a clinical trial of medicinal products?

Is the trial objective to study the therapeutic, diagnostic or preventive effect of one or more medicinal products?

Yes/No

Is the trial objective to identify or investigate adverse reactions from one or more medicinal products?

Yes/No

Is the trial objective to study the pharmacological effect (pharmacodynamics) of one or more medicinal products?

Yes/No

Is the trial objective to study the absorption, distribution, metabolism or excretion (pharmacokinetics) of one or more medicinal products?

Yes/No

If the answer is yes to either of the four questions above, your trial falls under the definition of a clinical trial. Therefore, it must be notified to the Danish Medicines Agency - unless it is a non-interventional study.

Is your trial a non-interventional study?

Does the treatment of trial subjects take place without randomisation?

Yes/No

Is the decision to prescribe the medicinal product made independently of the trial protocol?

Yes/No

Does the treatment with the medicinal product follow clinical practice, and is it independent of the trial protocol?

Yes/No

Is the medicinal product used for an authorised indication compliant with the medicinal product's summary of product characteristics?

Yes/No

Is the medicinal product marketed in Denmark?

Yes/No

Do the procedures follow normal clinical practice, i.e. without extra procedures such as blood tests, clinical examinations, additional diagnostic tests or the like?

Yes/No

Are data analysed only by means of epidemiological methods?

Yes/No

If the answer is yes to all of the above questions, the trial is a non-interventional study, which is not to be notified to the Danish Medicines Agency.

Contact us if you are still not sure

If you are still not sure whether or not your clinical trial needs to be notified to the Danish Medicines Agency, please send an email to us with the protocol or protocol synopsis along with details about the products expected to be used in the trial. Please send your email to kf@dkma.dk.

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