Upon completing Module 1, students will be able to:

• Understand the fundamentals of selecting and defining specific study populations relevant to clinical drug development in hepatology.
• Formulate clear, measurable, and clinically relevant inclusion and exclusion criteria to ensure scientific validity, patient safety, and generalizability in hepatology clinical trials.
• Identify pitfalls concerning patient and eligibility criteria selection across phases of clinical drug development with implications on feasibility, endpoints, and drug label.