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Clin Research Regulations
Course | Course Title | Class | Lab/ Shop | Clinical/ Co-op | Credit |
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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.
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This Course can be found in these Programs of Study
- Nanotechnology - Clinical Trials Research - Certificate (Day)