Dec 01, 2021  
2017-2018 School of Graduate Studies Catalog 
    
2017-2018 School of Graduate Studies Catalog [ARCHIVED CATALOG]

CRH 701 - Regulatory Affairs

3 Credit(s) The course covers international guidelines, U.S., Canadian and European requirements and national laws. The course outlines the procedures for submitting a proposed study to the ethics committee/regulatory authority and their approval processes in selected countries. The course also focuses on essential documents in clinical research, such as the protocol and the patient informed consent.