The Commission has published guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic. The aim is to mitigate the disruption of clinical research in Europe and the negative effects of the pandemic, without compromising on quality and safety. 

With more than 200 coronavirus clinical trials now registered in the EU database (EudraCT), the guidance offers recommendations for simple and flexible measures to respond to the current situation, and to ensure that patients participating in clinical trials across the EU can continue receiving their medicines.

Key recommendations of the guidance cover:

Distribution of medicines to patients in clinical trials: the purpose is to protect the safety and well-being of trial participants and the integrity of the clinical trials. This recommendation takes into account social distancing measures and possible limitations in trial site/hospital resources.

Remote source data verification (SDV): the verification of the raw data in hospitals can become extremely difficult during the pandemic due to safety measures, such as social distancing. Remote SDV to conclude a trial could facilitate the marketing authorisation of coronavirus and life-saving medicines.

Communication to authorities: urgent actions to protect trial participants against any immediate hazard or other changes with an effect on patient safety or data robustness might become necessary to mitigate disruptions during the ongoing public health crisis. The guidance clarifies the classification and notification of these actions.

These measures will be used exclusively during the coronavirus pandemic, and will be revoked once the current health crisis in the EU/EEA has been surpassed.