UK Explains Dos And Don’ts Of Remote Clinical Trial Monitoring
Much-Awaited Guideline Outlines Critical Functionalities For EHR Systems
Updated UK guidance describes the factors that clinical trial sponsors and investigator sites must consider when giving appointed representatives direct access to the electronic health records of participants in clinical trials to check source data.
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By formally adopting a modernized definition of a clinical trial site, Health Canada is hoping to provide greater flexibility to sponsors who want to incorporate decentralized elements in their trials.
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.
New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.