This course is described for students interested in the scientific, and practical aspects of clinical trials. Topics include types of clinical research, study design, treatment allocation, randomization, sample size requirement, statistical methods for analysis of clinical trial data, good clinical practice, ICH, adverse events, clinical trial activity and documents patient consent and ethical concerns, and monitoring and interpretation of the results. Students will complete homework assignments, explore key ideas, criticize a protocol and recently published medical literature, and design a clinical trial investigation in their own field of interest. The final project for the course, including protocol, informed consent, IRB document and case report form, will be the most achievement for results of clinical trial practice.