Clinical Research 2.0? All you need to know about the planned ICH GCP revision

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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[@sergejgraf4074]

Thank you Andreas! Awesome summary and presentstion on changes of ICH E6 R3 draft in small digestible bits.
I love the fact you added your own view point and perspective on the topic as well as putting and outline and conclusion of your expectations and wishes for the revision. Hopefully, some of those will end up in the final version.

[@k.d.6114]

THANK YOU!

[@vasudhakadam508]

Sir this is updated new guideline I think so please reply as it updated in this or last month correct me if I am wrong

[@Konda9871]

ICH E6 (R3) has been released as draft guidance in May of 2023. It is planned to be finalized and released by the end of 2024 - but more likely within 2025.