An amendment must be submitted if ANYTHING about the clinical research study changes following the initial review and receipt of approval by the Duke Institutional Review Board (IRB) (“Amendments to IRB-Approved Studies” policy http://irb.duhs.duke.edu/modules/irb_pols/index.php?id=3). Examples include: changes (adding/removing) to the Key Personnel list; changes to the protocol and/or consent form, correspondence to enrolled subjects, storage of data, etc.
User Guides are available on the eIRB website (https://eirb.mc.duke.edu) and additional information is available on the IRB website (http://irb.duhs.duke.edu/).