The Status section of the approval dialog has been modified – moved to the top of the dialog, color changed from grey to blue, is now required, and a new tooltip with the message, “Select Approved if you are ready to share the approval and Pending to save and return later.” This is to ensure that the Reviewing IRB and/or Study Manager marks the Status of the approval they are uploading since in the past it was often missed.

The Type of Study is also now editable at the review level when uploading a continuing review and study-wide amendment.

Previously, when indicating the Type of Study as Minimal Risk, the categories are only displayed if selecting the Review Type as ‘Initial Review: Expedited.’ IREx now displays the Minimal Risk categories whether the review type is Expedited or Full board and is not required.