This meeting will review updated expectations for site staff under the ICH E6(R3) Good Clinical Practice guidance. Key topics include early trial preparation, robust data governance, enhanced source data accountability, validated system requirements, and regulatory inspection readiness. Investigators and site teams will gain practical strategies to strengthen compliance and improve trial conduct.

Key Takeaways:

• Prepare early: Align site processes and systems with ICH E6(R3) requirements.

• Train your team: Ensure staff understand and follow new expectations for documentation and data handling.

• Use validated systems: Maintain proper source data, audit trails, and systems validation.

• Strengthen security: Use individual logins and safeguard data with backups and recovery plans.

• Stay inspection-ready: Document actions and promptly resolve issues to support quality and compliance.