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ICH GCP E6(R3) Annex 2

  • 11 jun
  • 1 minuten om te lezen

Clinical trials continue evolving, and so does ICH GCP E6(R3)!

Annex 2 is catching up with reality.


The finalization of Annex 2 acknowledges what many of us in clinical research have already been doing: more decentralized approaches, digital tools, and real-world data being integrated into clinical research.


Annex 2 provides additional guidance on how innovation and participant protection can continue to go hand in hand.


Some notable developments include:


🟠 Continued focus on robust investigator oversight and participant safety, regardless of where trial activities take place

🟠 Clearer expectations around the use of real-world data, with a focus on fit-for-purpose 

🟠 Direct-to-patient shipment of investigational products, supporting decentralized trial designs

🟠 Ensuring digital tools and decentralized procedures remain practical, user-friendly, and participant-centered


Annex 2 embraces a flexible, risk-based, fit-for-purpose approach while staying true to the core principles of Good Clinical Practice!


Ad Hoc Clinical is already a fan of this positive step towards making clinical trials more accessible, efficient, and aligned with the realities of modern research. 👏




 
 
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