EU Makes Only Limited Use Of Remote Clinical Trial Monitoring
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.
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EU regulators are eager to roll out harmonized requirements for decentralized clinical trials by the end of 2022 and so have decided to tackle some of the notably trickier issues in greater detail later on.
US FDA Raises Problems With EU Data Protection Reg, But Are They Among Those Misunderstanding It?
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Companies Urged Not To View EU Privacy Law As A Barrier To Conducting Decentralized Trials
A senior regulator from the European Medicines Agency says that while the EU General Data Protection Regulation can be intellectually challenging, the law is needed, and it should not deter companies from conducting decentralized clinical trials because of concerns they might have over the use of digital tools to capture and process patient and trial data.