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Clin Research Regulations

Course Course Title Class Lab/ Shop Clinical/ Co-op Credit
CTR 115 Clin Research Regulations 3 0 0 3
Prerequisites: None
Corequisites: None
Effective Term: Spring 2001

This course covers the range of national and international regulations governing the development of drugs, diagnostics, medical devices, and biologics. Topics include a review of the regulatory agencies, guidelines for regulatory application, required documentation, and preparation for compliance audits. Upon completion, students should be able to demonstrate a basic understanding of regulatory processes associated with clinical research and describe effective means of compliance.


This Course can be found in these Programs of Study