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In view of the disruptions caused by the Russian invasion of Ukraine, the European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) are issuing initial advice for sponsors on how to manage the conduct of clinical trials in this situation.
The ongoing war in Ukraine may require sponsors to adjust the way clinical trials are run in this region, and sponsors may need advice on how to deal with the impact of protocol deviations and other consequences of the disruptions. Certain changes and protocol deviations in the current situation are unavoidable, when for example scheduled study visits cannot take place, or arrangements need to be made to transfer trial participants who are fleeing Ukraine to other investigator sites of the same trial in the European Union (EU). Adaptations will also be needed to protect the participants’ right and safety, including the continuation of ongoing trial treatment if possible, as well as to preserve the quality of the data generated by the trials. Sponsors have asked for guidance on how to handle the situation in terms of trial records, documentation, data collection, protocol deviations, and missing data with its potential impact on methodological aspects.
Read more about this guidance from EMA here.