About this Course
This course introduces the major concepts involved in the design and execution of clinical trials. We’ll explore the themes of ethical treatment of human subjects and Good Clinical Practice (GCP) that are emphasized throughout the program.
What You'll Learn
- Scientific method and study design
- Statistical concepts
- Different phases of clinical trials
- The role of the Food and Drug Administration (FDA)
- Issues involving Institutional Review Boards
- The Code of Federal Regulations as it relates to clinical trials
- Ethical principles, including informed consent and conflict of interest