CRES 730 Design and Implementation of Clinical Trials

The course first provides an in-depth focus on design, implementation, and management of different types of clinical trials. This course then will cover registration and design of randomized clinical trials, including single blinded and double blinded trials, early proof of concept trials, phase I, II and III designs, clinical trials of orphan medications. Federal regulation and compliance issues will be covered. Students will be prepared to be Clinical Trial Administrator and/or Principal Investigator at the end of this course.

Credits

3

Outcomes

1. 1. Identify the components that must be present to define a clinical research study as a clinical trial.
2. 2. Define the three phases of a clinical trial required for submission to the FDA.
3. 3. Apply the appropriate FDA Approval process to a research project.
4. 4. Connect an empirical research question to a theoretical model that will support and increase the validity of the research design project.
5. 5. Calculate statistical power to determine the number of participants required to make a specific research inquiry generalizable
6. 6. Report methodology in a way that is repeatable, reliable, and valid
7. 7. Design a protocol which includes strategies for participant compliance and data management
8. 8. Apply project management strategies to the proper conduct of a clinical trial.
9. 9. Determine compliance with current legal and ethical standards
10. 10. Recognize guidelines that must be considered post-FDA-Approval and when a product goes to market.
11. 11. Discuss the role of patent and trademark applications in clinical trials.