Prereq: consent of instructor. This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles with explanation and analysis of selected portions of the Code of Federal Regulations (CFR), appli-cable to clinical research during the new drug development proc-ess. The case study approach is used in this course since the drug development industry translates these regulations into both written and unwritten standards, practices, and guidelines. Each session will use activities to expand the inter-pretation of the regulations, further integrating real-life issues into the classroom. In order to ensure that classroom learning is linked with the students’ work experiences, there will be an outside project re-quired which will incorporate the course work with the on-the-job situations, and a final presentation to share the learning with the en-tire class.