Clinical trials during the coronavirus epidemic (COVID-19)

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 sponsor 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 amendment to protocol 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 sponsor must notify Fimea of any exceptional arrangements as soon as possible and submit the protocol amendment. Fimea will prioritise the evaluation of these amendments. Delivery of investigational medicinal products from the sponsor directly to the subject is not in accordance with Finnish law.

Payments for protocol amendments during the COVID-19 epidemic

For protocol amendments relating to  the EMA guidelines of conducting clinical trials during the covid 19 pandemic a single fee of € 900 will be charged, regardless how many amendments per trial during and after the epidemic are required. The trials initially exempted from the processing fee shall not be charged for amendments.

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.

More information will be found on the website of the European Medicines Agency:

Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

Further information:

clinicaltrials@fimea.fi

This article has been updated 30.3.2020.