Regulations regarding the use of eConsent are highly variable amongst countries, even within the EU. To date, no EU regulation or guidance about eConsent in clinical trials exists. Nevertheless, it remains critical to quickly adopt eConsent for hybrid and decentralized trials to keep research on track during the COVID-19 pandemic. Evidence indicates that the use of eConsenting methods has advantages over traditional paper methods. The clinical research industry is long overdue in implementing this practice, which offers quick, secure, and flexible enrollment of research participants.
Download this guide for an overview of the current regulatory situation in nine countries.