European Medicines Agency Updates COVID-19 Clinical Trial Management Guidance
The European Commission and European Medicines Agency (EMA) as well as the Heads of Medicines Agencies (HMA) have added new recommendations on distribution, monitoring, remote source data verification (SDV) and communication with authorities to their guidance on managing trials during COVID-19.
In the update, the EMA and HMA state that remote SDV will be considered only for trials that are studying products that will treat or prevent COVID-19. Remote SDV may also be considered for pivotal trials of products that treat serious or life-threatening illnesses where significant unmet treatment needs exist. To avoid treatment interruptions and visits to sites, the updated guidance also suggests sponsors should consider changing how investigational medical products are distributed to patients.
These updates coincide with recent guidance updates from the FDA, which has also provided new recommendations on remote clinical outcome assessments and remote monitoring, in addition to recommendations on obtaining informed consent and electronic common technical document waivers.