Mar 29, 2024  
Undergraduate Catalog 2009-10 
    
Undergraduate Catalog 2009-10 [ARCHIVED CATALOG]

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CTA 5400 - Clinical Study Administration II


The course builds on the content of Clinical Study Administration I and presents the steps necessary to initiate, monitor, and close clinical trials within the context of Food and Drug Administration (FDA) regulations, Canadian Health Protection Branch regulations, and International Conference on Harmonization guidelines for Good Clinical Practices. Topics include: study monitoring, source document review, drug and device distribution and accounting, data correction and management, adverse event reporting, auditing and preparing for FDA inspection, Data review and summaization and final study reports.

Prerequisites & Corequisites: Prerequisite: CTA 5300.

Credits: 3 hours



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