Category Archives: Reviewing IRB

New Feature: sIRBs Can Reset SSRPs

Agreements/ Reliance, FRL, Relying HRPP, Reviewing IRB, September 2020, Study-specific Reliance Plan (SSRP)

Single IRBs (sIRBs) now have the ability to reset and edit an accepted Study-Specific Reliance Plan (SSRP) for Relying Institutions. When this happens, the Relying Institution is notified of specific changes that were made and can log in to accept the revisions. Then, IREx sends an email, “Relying HRPP Accepted Revised SSRP,” to the sIRB and Relying Institution once the reset SSRP is accepted. Additionally, the date when the revised SSRP was accepted will be reflected on the Status Summary tab and export. (Of note: the sIRB also maintains the ability to edit the SSRP for a Relying Institution before it is accepted.)

As a reminder, the SSRP, used to document how the flexible elements of the SMART IRB Agreement will be implemented, is established when the sIRB creates a study in IREx. Relying Institutions indicate reliance on the sIRB by accepting the SSRP.

New Feature: Agreement Checker Available to All Users

August 2020, FRL, IREx Access, IREx Study Manager, Reviewing IRB

Our newest IREx Feature, the “Agreement Checker”, is a dynamic report page allowing you to list potential participating sites to see if they have signed the SMART IRB reliance agreement, joined IREx, and signed the sIRB’s Letter of Indemnification, if applicable. The list can also be exported into a comma-separated values (CSV) file. The Agreement Checker can be of particular help to sIRB’s who want to contact sites to complete agreements before a study is created in IREx, or for study managers gauging site readiness and preparing reliance instruction for sites (sample here). The “Agreement Checker” is located under the Resources section on the IREx homepage after logging into IREx.

Updated Feature: New Document Types on Approvals

Approvals, Coordinator, FRL, IREx Study Manager, June 2020, Relying HRPP, Reviewing IRB, Study PI

Document types are used in IREx to help manage files associated with a study’s approval. For clarification, IREx has renamed Consents to Consents & Assents, and added document types for Grant Application, Measures, Recruitment & Advertisements, and Other IRB Approved Documents. The new categories will make it easier for users on IREx to find their study documents.

New Feature: Tracking Combo Sites Now Supported in IREx

Approvals, Edit Participating Sites, IREx Study Manager, IREx Study Setup, Local Considerations, May 2020, Relying HRPP, Reviewing IRB, Status Summary Tab, Study PI

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.

Updated Feature: Redesigned Participating Sites Dialog for Study Managers and sIRBs

Edit Participating Sites, FRL, IREx Study Manager, IREx Study Setup, May 2020, Reviewing IRB

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.

New Feature: API Available

API, February 2020, FRL, Reviewing IRB

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

Approvals, FRL, IREx Study Manager, March 2020, Reviewing IRB

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.