Nov 08, 2024  
2020-2021 Cal State East Bay Catalog 
    
2020-2021 Cal State East Bay Catalog [ARCHIVED CATALOG]

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BSTA 663 - Clinical Trials in the Pharmaceutical and Biomedical Industries


Units: 2
Statistical principles, design, management of clinical trials. Topics include: recruitment, treatment allocation, stratification, blinding.  Practical applications.  Ethics of clinical trials.  Data collection, data analysis. Data integrity, monitoring.  Domestic/international regulatory guidelines emphasized. Professional protocols. Introduction to CDISC.  Report writing, oral presentation. 

Prerequisites: BSTA 662.
Equivalent Quarter Course: BSTA 6653.
Possible Instructional Methods: Entirely On-ground.
Grading: A-F grading only.



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