Course Number
16:137:580
Credits
3
Instructor's Profile
Semesters(s) Offered
Spring
Fall
Description
Gain a basic understanding of good clinical practice in the pharmaceutical industry through practical, hands-on experience in the multifaceted area of clinical research. Study the complexity of clinical trials as related to protocol development and implementation, protection of human subjects, "informed consent" regulations, data management and reporting, the use of electronic systems and tools, the process of drug-supply management, and labeling.
Course Objectives
Upon completion of this course, be able to:
- Develop a clinical trial protocol using design elements required by the US Food and Drug Administration.
- Outline the FDA requirements for the safety and protections of human subjects.
- Describe the roles and responsibilities for investigators and sponsors.
- Develop operational processes and tolls to set-up and execute a study.
- Outline the requirements for study monitoring and quality oversight.
Testimonials
Course Testimonials
"Overall, I feel that this course offered a holistic view of the clinical environment by addressing the functional roles involved, the drug approval process and ethical considerations."
Technical Skills
- Clinical trials
- Clinical research
Transferable Skills
- Teamwork
- Presentations