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: Reviewing IRB
Updated Feature: Redesigned Participating Sites Dialog for Study Managers and sIRBs
The Participating Sites Dialog, used by the SIRB or Study Manager to add participating sites to a study, has a new intuitive design. Here, a site can be added with the PI and/or Coordinator information. If the PI or coordinator is an existing IREx user, their information will be auto-filled. You can also add additional FWAs if one study team engages multiple FWAs (“Combo Site”). Please watch our 3-minute YouTube video to learn more about adding sites to a study.
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: API Available
The IREX API is now available for Single IRBs who wish to transfer data between their local electronic IRB system and IREx. IREx API is able to push the creation of a new study, lead site initial approval, and relying site initial approval from the e-IRB system to IREx. It can also pull reliance documentation into the e-IRB system. All of these features are designed to streamline information entry between systems, making data entry faster and more accurate. If interested, please see our API page for more information.
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.
Updated Feature: Clarified “Verify Study Team Contacts” in Getting Started Checklist & Dialog
To view or add other study team members to a study in IREx, Relying HRPPs or PIs press “Verify Study Team Access” in their Getting Started Checklist.
Additionally, we rearranged the Study Team Contacts dialog to make it easier to see which study team members already have access to the study. Now users with access are listed on the left side of the dialog, and you can add new users using “Add A Contact” on the right side of the dialog.
New Feature: IREx API Allows Single IRBs to integrate their e-IRB System with IREx
The goal of the IREx API is to exchange data between a single IRB’s (sIRB) local electronic IRB (e-IRB) system and the IRB Reliance Exchange (IREx). Given that IREx captures (a) all the information an sIRB needs to review and grant initial IRB approval for a participating site and (b) the actual IRB approval information and documents for participating sites, the IREx API will facilitate bi-directional data exchange. The sIRB can pull participating site information from IREx into its e-IRB system for review and push participating site approvals to IREx to facilitate sIRB communications and approval notifications.
Updated Feature: Institutional Profile now allows Save & Return Later feature
Institutions wishing to complete or make iterative updates to their Institutional Profile can now press “Save & Return Later” to publish what was completed or updated without having to complete the entire profile. This helps make it easier for HRPPs to make quick updates.
Updated Feature: IRB Number Added to Reviewing IRB Dashboard
The Study Dashboard for Reviewing IRBs now includes an IRB number column. Reviewing IRB Liaisons can sort studies according to IRB number in addition to study title, number of participating sites, number of approved sites, expiration date, and next step. This was a request from IREx users, as sIRBs often use IRB numbers to quickly identify studies and organize their tasks.
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.