To provide more information about amendment approvals uploaded to IREx, the study-wide and site-specific amendment approval notifications will now include the study protocol version number and the change summary, both of which are entered by the Reviewing IRB. TIPS:
- Minimize confusion for the study teams by ensuring the “protocol version” matches the version that is listed on the protocol.
- Increase consistency by including the amendment # from your IRB system at the beginning of the change summary.
Additionally, when uploading site-specific amendments, sIRB Liaisons or Study Managers will now be required to provide a description of the changes. TIP: We recommend starting the change summary with the amendment # to help the site identify the change.