Key Changes In The Revised EMA Guidance On Clinical Trials During COVID

Excerpt from the Article:

In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent changes in the global health landscape. Here’s an overview of what’s new.

Expanded use of remote source data verification

The primary change is to the EMA’s recommendations for the use of remote source data verification (rSDV). Previously, the guidance stated that rSDV be considered only in limited circumstances for trials involving COVID-19 treatment or prevention or during final data cleaning before database lock in pivotal trials for serious or life-threatening conditions with no satisfactory treatment. The new version expands the list of circumstances in which rSDV can be justified, including:

• When the absence of SDV for critical data is likely to pose unacceptable risks to participants’ safety or reliability/integrity of data results
• Trials involving especially vulnerable participants such as children or those temporarily or permanently incapable of giving informed consent
• Any pivotal trials

Click the button below to read the entire Article:

Continue Reading The Article