Institutional Review Board
Jump to Main Content



Welcome to the Website for the
Duke University Health System
Institutional Review Board





FDA Regulations related to electronic records and electronic signatures are located at 21 CFR Part 11.  An Institutional statement regarding Part 11 has been developed to assist study teams in responding to inquiries from sponsors and CROs.  This statement and Duke Medicine's notification to FDA of the intent to use electronic signatures can be found here.  

© 2015, Duke University Health System   DHTS Web Services DHTS Web Services