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Nov 08, 2024
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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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