This policy describes the circumstances in which the DUHS IRB may choose to serve as a central IRB on a multi-site study, or serve as the IRB-of-Record for an external (non-Duke) site. Additionally the policy outlines the responsibilities of the relying site, and the responsibilities of the Duke study team involved in a multi-site study, when the DUHS IRB is acting as the central IRB for the multi-site study.