HSCI 725 - Fundamentals of Clinical Trials (Core course)

3 Credit(s)

This course is designed to teach the fundamentals of a good clinical trial in the evaluation of a new drug or device, be it industry, federal or philanthropic sponsored. This course begins with the evaluation process leading up to human volunteer trials, through elements in designing a trial, writing the scientific protocol, considering regulatory issues and human subjects’ protection, through elements in protocol development/implementation, and quality assurance.