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ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient

 
• By Vibha Sharma

The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.

African doctor wear headset consult female black patient make online webcam video call on laptop screen. Telemedicine videoconference remote computer app virtual meeting. Over shoulder videocall view.
ICH GCP Principles Are Being Modernized To Support diverse trial types and data sources • Source: Shutterstock

The International Council for Harmonisation is inviting stakeholder feedback on its keenly awaited ICH E6(R3) draft guideline on good clinical practice requirements that has been updated to explain how GCP principles can be applied to emerging innovations in trial design and conduct.

Key Takeaways

  • The ICH’s much-awaited draft ICH E6(R3) guideline that aims to address the application of good clinical practice (GCP) principles to the increasingly diverse range of clinical trial types and data sources is out for stakeholder consultation

When finalized, the guideline is expected to establish harmonized GCP standards for conducting trials that use real-world data, incorporate decentralized elements which allow some or all trial activities to be conducted in or near a trial

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