College of Graduate and Professional Studies Catalog - Fall 2023

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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

Student Learning Outcomes

  1. 1. Connect their empirical question to a theoretic model that will support and increase the validity of their research design.
  2. 2. Design methodology in a way that is repeatable, reliable, and valid.
  3. 3. Calculate statistical power to determine the number of participants required to make a specific research inquiry generalizable.