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May 19, 2024
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2023-2025 Catalog Volume XXXI Ver 1
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PSC 6017 Design, Management, & Monitoring of Clinical Trials I
Lecture: 3 Lab: 0 Practica: 0 Total Credits: 3
This course provides detailed overview of the clinical phase of drug development, including the design, management, and oversight of clinical studies. The student is introduced to the history of clinical evaluation and to principles that define and govern the conduct of Phase 0 through Phase 4 clinical studies. Student are instructed on the major elements of a clinical study including but not limited to the requirements for submitting an IND to initiate a clinical study, the generation of a clinical protocol, clinical site selection and audit, ethical considerations, submission of an NDA, and post-approval quality and regulatory oversight.
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