Combo Sites, defined as one study team engaging multiple FWAs for the same study, are now supported on IREx. In the past, SIRBs and Study Managers had no way to group sites together to ensure all documentation was in place before review. Moreover, relying sites had to duplicate information (e.g., PI Survey). Now, Combo Sites are marked with a blue link icon throughout IREx and have several features to ensure reliance documentation is completed by each FWA in the most streamlined way possible. For more information, please visit our resources page, organized by role on our menu toolbar and watch our Combo Site trailer on YouTube.
Category Archives: Approvals
Updated Feature: Enhanced Versions Box
The Approvals Versions box, located on the left-hand bar of a study page, has been enhanced so that studies with numerous sites can easily view SIRB approvals sorted by Relying Sites and sites who are Registered/In Progress. In addition, the Approvals Versions box now features a scroll bar so users can quickly navigate to view a site’s approval status.
New Feature: sIRBs are no Longer Required to Upload Overall Approval for Continuing Reviews & Study-wide Amendments
To further streamline the work of the sIRB in IREx and avoid delays in posting approvals, the Study Manager can now post the overall/lead site approval for continuing reviews and amendments. In the past, the sIRB had to upload this before the Study Manager could upload approvals for Relying Sites. Now, this is a single process that can be completed by the Study Manager.
The sIRB is now only required to create the study and post the overall study or lead site approval initial approval. Thereafter, all approval documents are managed by the Study Manager.
New Feature: Editing Approvals Always Unlocked for Reviewing IRBs
In the past, the Reviewing IRBs had to contact an IREx Administrator in order to edit an existing approval (e.g., add/correct an approval document). Reviewing IRB Liaisons are now able to do so at any time. When an approval is edited, an email will notify Relying HRPP Liaisons and study team personnel specifying the changes made. This feature makes it easier for Reviewing IRBs to correct information on IREx while also maintaining clear communications about changes.
New Feature: Email Notifications for Updated Approvals
A new email notification is now sent when any existing approval – for the overall study or a participating site – is updated. For example, if additional documents are uploaded or exchanged, an email will notify the relying site’s HRPP and study team personnel of the revisions and the exact changes are detailed in a table. The notification will bring clarity to the email notifications and ensure sites are aware of updates or changes to their approval, as specified in section 5.9 of the SMART IRB Agreement, “Notification of IRB Decisions, Changes, Lapses in Approval.”
Updated Feature: Renamed Tabs
You will notice some rewording of the study page tabs. The first, blue tab is now titled Study-wide IRB Approvals (before called “Reviewing IRB Approvals”) because these documents are relevant to all sites. The second, orange tab is now titled Site-specific IRB Approvals (before called “Relying Site Approvals”) because it captures documents for each site. Both tabs retain the same functions as before but are more appropriately named.
Updated Feature: Protocol Version
When creating a study or adding an amendment, a version name is required for the protocol. The “Protocol Version” field has been relabeled as “Protocol Date and/or Version” to clarify that users should enter the version number as entered on the protocol, which is often a date. In IREx trainings, users have also been encouraged to enter the amendment number in the summary of changes so that it is reflected on IREx and on email notifications sent out when changes are made.
Updated Feature: Modified Continuing Review Documentation for Studies Closed to Enrollment
Although studies that are designated as Greater than Minimal Risk (GTMR) require consent forms, IREx now allows for the input of GTRM Continuing Reviews that are reviewed via the expedited review process. A consent form is no longer a required document for these reviews to better facilitate, for example, studies that are closed to enrollment. This change helps accommodate nuances of different phases of study conduct.
Updated Feature: Amendment Notifications Now Include Change Summary
Study-wide and site-specific amendment email notifications have been updated to include the protocol version number (as entered by the Reviewing IRB), the automatically assigned “Revision #” when a study-wide amendment does not change the protocol, and the change summary for the amendment. That now means sIRBs and Study Managers are required to provide a description of changes when uploading site-specific amendments, as is already required for study-wide amendments. IREx recommends starting the change summary with the amendment number to help the site identify the change. This information is then embedded in the notification email to help sites and sIRBs communicate more clearly about amendments.
Updated Feature: Enhanced Study-wide and Site Amendment Email Notifications
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.