Regulatory Issues in Clinical Trials

Catalog description

The overarching goal of this course is to help participants understand the essentials of compliance issues as it is related to conducting clinical trials using drugs and devices that have been or yet to be approved by FDA. This course will also help biomedical innovators recognize the importance of Human Subject Protection (HSP) and abide by the FDA regulations to conduct clinical trials with the new drugs/devices that are being designed to advance patient-care. The course will describe regulatory standpoints for human subject protection, how to obtain approvals and develop clinical protocols for conducting clinical trials. An overview about clinical epidemiology, biostatistics and data management and analysis will be provided. Graded on A-F basis only. Credit Hour s : 3