EU Clarifies Interplay Between CTR And GDPR
A Q&A document from the European Commission elaborates on alternative legal bases, other than informed consent, for processing clinical trial data under the General Data Protection Regulation.
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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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-eight documents have been posted on the tracker since its last update.
A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.