May 02, 2024  
2020-2021 Catalog Volume XXX Ver 2 
    
2020-2021 Catalog Volume XXX Ver 2 [ARCHIVED CATALOG]

PSC 6016 Principles of Clinical Research: An Introduction


Lecture: 2 Lab: 0 Practica: 0 Total Credits: 2
This course provides an overview of the complex process and procedures required to evaluate the safety, toxicity, and efficacy of a drug in human subjects and patients. Topics include animal testing requirements, design of clinical studies, protocol development, institutional review board approval, establishment of data safety monitoring boards, subject and patient enrollment, study conduct and monitoring, and regulatory requirements for the evaluation and registration of human pharmaceutical products.