Amendment IRB Review/Approval

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/).