eClinical Technology and Industy News

EU regulators expand use of remote source data verification in clinical trials

Excerpt from the Article:

The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.

Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivotal trials investigating serious or life-threatening conditions with no satisfactory treatment option.”

In the updated guidance, now in its fourth version, the regulators have dramatically expanded the types of trials that may use rSDV in addition to other established methods for trial monitoring, such as on-site, centralized and off-site monitoring, during the COVID-19 pandemic and in line with EU and national law.

Now, in addition to trials involving the treatment or prevention of COVID-19, the guidance allows for the use of rSDV in trials investigating serious or life-threatening conditions, regardless of trial phase or whether there are satisfactory alternatives on the market.

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