CTS 700. Introduction to Clinical Trials. 3 Credits.

This course is designed to be a basic Introduction to Clinical Trials, which will include the various stages of clinical trials, regulation of clinical trials, ethics in clinical research, and basic clinical research operations.

CTS 701. Responsible Conduct of Research. 3 Credits.

This course is designed to be a basic Introduction to the Responsible Conduct of Research, which will include policy, law, regulation, ethics, and compliance.

CTS 702. Pharmaceutical & Medical Device Studies. 3 Credits.

This course is designed to be a basic Introduction to Pharmaceutical & Medical Device Studies, including their design, conduct, and their role in bringing drugs and devices to market.

CTS 703. Clinical Trials Operation & Management. 3 Credits.

This course is designed to be a basic Introduction to Clinical Trials Operation and Management, including team roles and responsibilities, responsible conduct of research/compliance, protocol writing, data management and analysis, submission for regulatory approval, and dissemination of results.

CTS 704. Pharmacometrics: Model-Informed Drug Development. 3 Credits.

This course is designed to be an Introduction to model-informed drug development (MIDD), which will include basic information on the quantitative scientist's role in drug development, the basic principles of MIDD, and practical applications of modeling & simulation to inform drug development.

CTS 705. Clinical Data Management and Research Informatics. 3 Credits.

This course is designed to be an Introduction to clinical data management and research informatics across interventional, observational and health systems research. Prereq: CTS 700.

CTS 706. Clinical Study Design and Protocol Development. 3 Credits.

This course is designed to be an introduction to clinical study design and protocol development in the context of clinical trials. This course is applicable to drug, device, behavioral and health systems research. Prereq: CTS 700.