Curriculum

This program requires the successful completion of three required courses and any two electives for a total of 15 credits. With the assistance of a curriculum advisor, students will choose from a variety of specialized courses depending on their educational objectives and employment-related experiences. Graduate credit will not be given for work-related experience.

Required Courses
CR 515S	INTRO TO CLINICAL TRIALS	3.00 credits
CR 545S	PHARMACEUTICAL LAW	3.00 credits
CR 612S	FUNDAMENTALS OF COMPLIANCE	3.00 credits

Electives
CR 525S	SCIENTIFIC WRITING & MED LIT	3.00 credits
CR 565S	Contemporary Issues in Human Research Protection	3.00 credits
CR 570S	Principles and Practice of Pharmacovigilance	3.00 credits
CR 609S	INNOVATIVE PRODUCE DEVELOPMENT	3.00 credits
CR 620S	BIOTECH/RESEARCH	3.00 credits
CR 625S	HEALTH POLICY AND ECONOMICS	3.00 credits

Course Descriptions

CR 515S INTRO TO CLINICAL TRIALS - 3.00 credits

This course introduces regulatory responsibilities of clinical investigators, sponsors, monitors, IRBs, FDA -all those parties intimately involved in clinical research. Information and exercises are designed to reinforce the elements of Good Clinical Practices.

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CR 545S PHARMACEUTICAL LAW - 3.00 credits

Presents principles and practices of the Federal Food, Drug and Cosmetic Act governing the research and development of pharmaceuticals and biologics for both humans and animals including an analysis of legal and social constructs affecting industry and the academic clinical investigator with emphasis on FDA enforcement actions.

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CR 612S FUNDAMENTALS OF COMPLIANCE - 3.00 credits

The study of the federal bodies and regulations that govern research. Topics include: the rules and regulations surrounding HIPAA and how it affects research on human subjects, the history and current role of the FDA, IACUC, and the IRB within the research arena. May be repeated twice for credit.

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CR 525S SCIENTIFIC WRITING & MED LIT - 3.00 credits

This course teaches the medical professional the ability to read for understanding, and evaluate validity of information a medical or scientific paper. In addition, the student learns how to recognize various types of medical literature and the basics of how to perform a review of the medical literature.

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CR 565S Contemporary Issues in Human Research Protection - 3.00 credits

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CR 570S Principles and Practice of Pharmacovigilance - 3.00 credits

This course is an introduction to the ethical, clinical, and regulatory complexities of medication safety and matters thinking skills for improving the quality and effectiveness of drug safety monitoring for both the pharmaceutical industry and its impact on the public.

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CR 609S INNOVATIVE PRODUCE DEVELOPMENT - 3.00 credits

This comprehensive course provides a solid foundation in new therapeutic product research and development for the subsequent courses in the CROM program. This course focuses on the process of drug and medical device development from early research, discovery, and product formulation, through the federal requirements form proving safety and efficacy. May be repeated twice for credit.

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CR 620S BIOTECH/RESEARCH - 3.00 credits

The study of the history, use and progression of biological techniques developed through basic research and now how it is applied to research and product development.

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CR 625S HEALTH POLICY AND ECONOMICS - 3.00 credits

The study of the development, analysis and communication of economic data in the context of clinical research. May be repeated twice for credit.

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