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May 02, 2024
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2020-2021 Catalog Volume XXX Ver 2 [ARCHIVED CATALOG]
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PSC 6018 Design, Management, & Monitoring of Clinical Trials II
Lecture: 3 Lab: 0 Practica: 0 Total Credits: 3
This course comprises a comprehensive presentation of the details involved in the conduct of human clinical trials. Building on the knowledge gained in PSC 6017, the student is instructed in concepts including but not limited to protocol development, power and sample size calculations, hypothesis testing, randomization methods, biostatistics, data analysis, and data management in the design of Phase 0 through Phase 4 clinical studies. Other concepts include procedures for assembling clinical results into the electronic common technical document (eCTD) format.
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