The European Medicines Agency (EMA), the Heads of Medicines Agency (HMA) and the European Commission (EC) have published a joint guidance on the management of clinical trials during the coronavirus pandemic. The guidance has been revised in February (Version 4) to include details on remote source data verification.

According to the Agencies, remote SDV should focus on the quality control of critical data such as primary efficacy data and important safety data. The sponsor should determine the extent and nature of remote SDV that they consider needed for each trial and should carefully weigh it against the extra burden that introduction of any alternative measures would put on site staff.

Download the guidance here.