- Does the treatment of trial subjects take place without randomisatin?
- Is the decision to prescribe the medicinal product made independently of the trial protocol?
- Does the treatment with the medicinal product follow clinical practice, and is it independent of the trial protocol?
- Is the medicinal product used for an authorised indication compliant with the medicinal product‘s summary of product characteristics?
- Is the medicinal product marketed in Iceland?
- Do the procedures follow normal clinical practice, i.e. without extra procedures such as blood tests, clinical examinations, additional diagnostic tests etc.?
- Are data analysed only by means of epidemiological methods?
If the answer is yes to all of the 7 questions above, your trial falls under the definition of a non-interventional study. Terefore, a clinical trial application does not need to be submitted to the Icelandic Medicines Agency.
If you are not sure whether or not your clinical trial needs to be notified to the Icelandic Medicines Agency, please send us an email with the protocol or protocol synopsis along with detalis about the products expected to be used in the trial. Please send us email to [email protected]
Further information is available in Volume 10 - Guidance documents applying to clinical trials.