I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
About
This course is recommended for CRAs, lead CRAs, monitoring leads, central monitors, project managers and quality professionals overseeing trial monitoring. On completion, learners will be able to design a risk-based monitoring plan, define and react to KRIs, lead remote source review under privacy constraints, and articulate the limits of remote monitoring under different regulatory regimes. Aligned with ICH GCP E6(R3), TransCelerate RBM framework, and FDA, EMA and MHRA monitoring guidance.
Course Syllabus
- What clinical trial monitoring is
- The evolution of monitoring
- Traditional on-site monitoring
- Remote monitoring
- Centralized monitoring
- Risk-Based Monitoring & RBQM
- Regulatory guidelines
- KRIs and dashboards
- Hybrid monitoring
- Modern monitoring is risk-targeted and data-driven
- A day in the life
- The tools
- Data review
- Centralized statistical monitoring
- Communication with sites
- Documentation
- Team interactions
- Key skills
- Remote monitoring is rhythm
- Course complete
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