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Quality Management > Intermediate
AI-Assisted ICH E6(R3) GCP Compliance for Clinical Trials
A practical, AI-aware guide to ICH E6(R3) Good Clinical Practice for clinical operations, quality, and compliance professionals. Covers the lifecycle approach to quality, quality-by-design protocol development, risk-based monitoring, ALCOA+ data integrity, CRO and vendor oversight, deviations and CAPA, and inspection readiness - with clear guidance on where AI can responsibly support these activities under human oversight. Includes a capstone case study and a personal inspection-readiness action plan.
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What you'll learn
- Explain ICH E6(R3) core principles and the lifecycle approach to clinical trial quality
- Apply quality-by-design and risk assessment methods to identify critical-to-quality factors
- Design and interpret risk-based monitoring plans, including centralized and triggered monitoring
- Apply ALCOA+ data integrity principles to eSource, EDC, and AI-assisted data review
- Oversee CROs and vendors with documented governance and escalation pathways
- Manage deviations through root cause analysis, CAPA, and preventive action
- Build an inspection-ready TMF/ISF and a personal inspection-readiness action plan
Course content
Welcome and Course Roadmap
What You Will Build: an E6(R3)-Aligned Compliance Mindset
Why E6(R3) Matters Now
Core Principles and Lifecycle Thinking
Roles and Accountability: Sponsor, Investigator, CRO
Where AI Can and Cannot Help Under GCP
Requirements
- Basic familiarity with clinical trial roles and GCP concepts is helpful but not required
- No coding or AI experience needed
Description
A practical, AI-aware guide to ICH E6(R3) Good Clinical Practice for clinical operations, quality, and compliance professionals. Covers the lifecycle approach to quality, quality-by-design protocol development, risk-based monitoring, ALCOA+ data integrity, CRO and vendor oversight, deviations and CAPA, and inspection readiness - with clear guidance on where AI can responsibly support these activities under human oversight. Includes a capstone case study and a personal inspection-readiness action plan.
This course is designed for:
- Clinical operations, quality, and compliance professionals working under ICH E6(R3) GCP
- CRAs, CRCs, and study managers preparing for risk-based monitoring and inspections
- Sponsors and CRO staff who want to use AI tools responsibly within GCP oversight requirements
Instructor
SafeMeds Academy
Life-science curriculum specialist
Practical training for pharma, biotech, CRO, regulatory, clinical, PV, market access, medical writing, data, and AI-enabled teams across the globe.
How to earn your certificate
- Watch the lessons. Each lesson is marked complete automatically once you have watched 90% of its video — there is no button to click.
- Reach 100%. When all 42 lessons are complete, the final quiz unlocks in your course player and dashboard.
- Pass the final quiz. 20 multiple-choice questions, 70% to pass (14/20), with unlimited retries.
- Get your certificate. It is issued to your account automatically, emailed to you, and verifiable online.