By Bree Burks, RN, MSN, Veeva Systems, Inc.
The European Medicines Agency (EMA) has expanded the use and scope of remote source data verification (rSDV) in clinical trials. The updated guidance, now in its fourth version, justifies the use of rSDV on more trials with fewer restrictions.
This is a positive step forward for the industry as the new guidance balances patient safety with the needs of study sponsors, sites, and investigators in maintaining compliance and minimizing risk to trial integrity while dealing with disruptions caused by COVID-19.
Read how the updated guidance justifies the use of rSDV on more trials with fewer restrictions.