E6(R3) Good Clinical Practice: Annex 2 – Draft Guidance & Comment Reopening

This draft guidance from the International Council for Harmonisation (ICH) updates Good Clinical Practice (GCP) guidelines to include decentralized trials, pragmatic elements, and Real-World Data (RWD). The goal is to align global regulatory expectations while allowing flexibility within applicable laws.

Key highlights:

• The FDA reopened the comment period on March 13, 2025, for additional feedback.
• Investigators must maintain oversight of investigational products and comply with local regulations.
• The informed consent process remains essential, with strict documentation and compliance requirements.
• Clinical trial protocols should detail design elements and data sources to manage variability and ensure safety communication.
• Sponsors are responsible for participant safety, data integrity, and informed consent protection.

This guidance aims to enhance trial efficiency while maintaining high safety and quality standards.

Source: https://www.govinfo.gov/content/pkg/FR-2025-03-13/pdf/2025-04026.pdf

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