Welcome to our newest deep dive on the exciting developments in clinical research! Today's video is all about the upcoming ICH GCP revision – a key turning point that's reshaping the landscape of clinical trials and bringing us into the era of 'Clinical Research 2.0'. We'll unravel the crucial updates such as the shift towards fit-for-purpose systems, amplified transparency requirements, and changes to CRO outsourcing. Additionally, we'll break down the increased emphasis on risk-based quality management, showcasing its impact on your clinical trials. Learn about the latest recommendations for centralized monitoring and how new technologies and data governance procedures are transforming the roles of study sites and investigators. We'll also shed light on the proposed changes to essential clinical trial documents. This is a must-watch for everyone involved in clinical trials, whether you're a seasoned veteran or a newcomer to the field! Don't miss out on this comprehensive guide to understanding and navigating the ICH E6 (R3) revision!
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It’s all about the mindset, the GCP-Mindset 💡
