Changes to monitoring plan
Due to the coronavirus situation, there may be good grounds for reducing on-site monitoring of clinical trials. The need for monitoring visits to the research location will be assessed and only the critical visits will be carried out. This will avoid unnecessarily exposing people to the virus and thus spreading it further. The ordering party should seek to utilise other monitoring methods (e.g. centralised monitoring) so that any reduction in on-site monitoring does not affect the quality of the study and the safety of the subjects. Justified deviations from the original monitoring plan must be documented and, where needed, the appropriate notification of fundamental change to research plan must be submitted.
Delivery of investigational medicinal products to the patient
As the epidemic worsens, exceptional arrangements may have to be made for the delivery of the investigational medicinal products to the patient (e.g. delivery to the home address instead of handing over the medicinal products during subjects’ visits to the research location). In such cases, these exceptional arrangements must be essential for ensuring the continuation of the study, the safety of the subjects and the reliability of the research results. The ordering party must notify Fimea of any exceptional arrangements as soon as possible and submit the relevant notification of fundamental change to research plan. Fimea will prioritise the evaluation of these change notifications.
Fimea supports the prevention of the spread of coronavirus and the minimisation of such activities related to clinical trials which may potentially contribute to the spread of the virus and which are not essential for ensuring the safety of the subjects.
Those involved in clinical trials can obtain further guidance by following the updates on the website of the European Medicines Agency.