Category Archives: FRL

Updated Feature: New Document Types on Approvals

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.

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: Study Registration Redesigned and Questions Added for Participating Sites

TThe Study Registration page has been updated to give Participating Site HRPPs control of how their site is listed on a study. The new registration page allows the HRPP Liaison to confirm the site and PI listed, change the PI for your site, indicate that a different site is engaged by the PI, add additional FWAs for a single study team (“Combo Site”), or decline engagement in a study. Please visit our YouTube channel to watch a video on the new Study Registration process. Please visit our YouTube channel to watch a video on the new Study Registration process.

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.