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EU Makes Only Limited Use Of Remote Clinical Trial Monitoring

 
• By Vibha Sharma

While regulators worldwide are opening up to the possibility of remote verification of source data from clinical trial sites because of COVID-19 restrictions, this approach is finding less favor in the EU, mainly because of strict data protection rules.

Office binders with Medical records tags 3D rendering
COVID-19 Has Disrupted Onsite Monitoring Of Clinical Trial Sites • Source: Shutterstock

The COVID-19 pandemic has compelled regulatory agencies across the globe to offer some degree of flexibility in clinical trial processes to support ongoing research without compromising patient safety, data quality and data integrity.

Regulators in the US and the EU have done the same, but with “significant differences” in relation to remote source...

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