The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic (V4 04Feb21) expands the use and scope of remote source data verification (rSDV) in clinical trials.
Now, in addition to trials involving the treatment or prevention of COVID-19, remote SDV may be considered for trials:
– investigating serious or life-threatening conditions;
– where the absence of SDV for critical data may likely pose unacceptable risks to participants’ safety or the reliability/integrity of trial results;
– involving particularly vulnerable participants such as children or those temporarily (e.g. trials in emergency situations) or permanently (e.g. trials in patients with advanced dementia) incapable of giving their informed consent or
– in pivotal trials.