Clinical Trial Management

Run clinical trials that are safe, on time, on budget and inspection-ready, using the risk-based approach of ICH-GCP E6(R3).

Who it’s for

Clinical research associates, study coordinators, research nurses and project managers moving into trial management roles.

What you’ll be able to do

• Explain each phase of drug development and who is responsible for what
• Apply ICH-GCP E6(R3) principles, including quality by design and risk proportionality
• Read a protocol like a trial manager and run feasibility and site start-up
• Navigate UK and EU regulatory and ethics approvals and manage amendments
• Build and control a trial budget and manage site contracts
• Forecast recruitment and rescue a struggling trial
• Design a risk-based monitoring plan and manage safety reporting timelines
• Close a trial cleanly and stay inspection-ready

What’s included

• 9 in-depth modules, each with a structured lesson
• 9 module quizzes to check your understanding
• Worked examples and a practical exercise in every module
• About 60 hours of study, at your own pace
• Lifetime access, on any device
• Certificate of completion

How you study

Each module combines a structured lesson with a worked example, a practical exercise and key takeaways, followed by a short quiz. You need 70% to pass each quiz and can retake it as often as you like. Complete every module to finish the course.