Episode Details

David Vulcano, SCRS Honorary President, breaks down the recent ICH GCP R6 E3 revisions and explores their practical impact on clinical research sites. He discusses key topics such as the decentralization of trials, updated record retention guidelines, and the rising importance of digital health technologies and cybersecurity. David highlights that, although there’s considerable hype and some uncertainties, the new guidelines generally codify existing practices rather than overhaul them. The episode serves as a practical guide for sites to align their operations with both local regulatory requirements and the updated GCP standards while maintaining an open dialogue with sponsors and CROs.