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

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

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