Learn trial phases, design types, and statistical foundations in clinical researc.
Skills you will gain
- Clinical Trial Phases: Understand and describe the different phases of drug and device clinical trials.
- Trial Design Mastery: Identify and apply various clinical trial designs to suit specific research goals.
- Goal & Objective Setting: Define clear hypotheses, study objectives, and trial outcomes.
- Statistical Considerations: Grasp key statistical principles essential for designing clinical trials.
- Practical Design Application: Evaluate the feasibility of different trial designs and identify potential challenges.
Course Description
This course reviews the science that forms the basis of effective clinical trial design. You'll learn to classify and describe trial design by stage in drug and device development. The course covers the purposes of clinical trials, including types of trial designs. You'll learn to define hypotheses and study objectives and determine population and sample size.
Topics Include
- Local standards of practice affecting clinical trials
- Pharmacoeconomics
- Working with marketing to identify unmet medical needs
- Ethical considerations in clinical trial design
Additional Information
You'll gain hands-on experience designing clinical trials synopses and Phase 2 development strategies.
AI* - This course teaches students how AI supports study design and documentation, clinical trial setup and management, clinical data analysis, report generation, and data management processes.
Professional Credit
CA BRN/LVN Credit - Provider #CEP13114
This course applies to these programs: