CLRE 6300 - Clinical Study Design and Implementation

Prerequisite or co-requisite: CLRE 6100. This course provides the student with an overview of the process of designing and implementing a clinical research study. It takes into consideration the perspectives of both the sponsor and the clinical site. The course incorporates completion of the NIH Good Clinical Practice (GCP) course which is based on International Congress of Harmonization GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S. Successful completion of the course also provides the student with the NIH Certificate of GCP Course Completion. 3 credits.