Category Archives: March 2020

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.

Updated Feature: Clarified “Verify Study Team Contacts” in Getting Started Checklist & Dialog

FRL, Getting Started Checklists, March 2020, Reviewing IRB

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

API, FRL, March 2020, Reviewing IRB

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.