(3 semester credits)

An introduction to the basic elements of research design for clinical inquiry is provided in this course. Students explore the methods and goals of clinical research; formulation of the research objective and hypothesis; identification of outcome measures; issues of reliability and validity; randomization procedures; documentation requirements; and data collection, analysis, and interpretation. Sharpening critical-thinking skills, students consider the potential risks and benefits of a clinical trial case study, which they use to justify continuation or termination of the drug development process. They also examine practical aspects of clinical trial management, including the design of the case report form (CRF), clinical laboratory and multicenter trial administration, and outsourcing. Through a review of scholarly literature, students explore and describe the ethical and regulatory requirements for which professionals must account in the design of a clinical research study. Additionally, students explore health disparities and cultural diversity as factors that affect participation of subjects in clinical trials.