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Updated Feature: More Flexible Combo Site Documentation

Approvals, Email Notifications, FRL, IREx Study Manager, Local Considerations, November 2021, Reviewing IRB, Status Summary Tab

A Combo Site occurs when one study team engages multiple Federalwide Assurances (FWAs) for a given study. Because sIRBs often review and approve Combo Sites separately – so as not to delay study activation at one site – IREx has added new flexibility for Combo Sites.

Most importantly, sites in a Combo can now be reviewed and approved by the sIRB separately. To facilitate sites being reviewed by the sIRB as quickly as possible, the notification that local considerations have been completed for a site in a Combo is now sent to Study Managers and sIRBs instantly, rather than requiring all sites be complete. Additionally, after a site is reviewed and approved by the sIRB, the site’s approval can be posted to IREx instantly, rather than requiring all sites in the Combo to have approval before the documents can be posted. Given that combo sites may have separate consent forms or receive approval at separate times, combo site approvals are posted for each FWA/site, like the other sites on the study.

Updated Feature: One PI Survey per FWA engaged in a Combo Site

FRL, Local Considerations, November 2021, Relying HRPP, Study PI

PIs will now complete a separate PI survey for each FWA in a Combo Site, with the option to copy their PI survey responses from the other site in the study. A separate PI survey allows for more accurate capture of the conduct of the study for each site in a combo. As with all sites on a study, the HRPP of a site in a Combo validates the PI survey responses

Updated Feature: Lead Site Initial Approval, Study Manager, and Expiration Date added to IRB Exports

Dashboard, FRL, October 2021, Relying HRPP, Reviewing IRB

New fields have been added to data exports for sIRBs and Relying Site HRPPs. The new field for Lead Site Initial Approval (dateInitialReviewApproved) can be used to analyze study progress, such as time from Lead Site Initial Approval to Relying Site Approval. Study Manager (studyManager) and Expiration Date (studyExpirationDate) fields may help with managing contacts and anticipating study events, respectively. Download and save csv exports using the “Export” dropdown on the top righthand side of both Reviewing Site’s Studies and Participating Site’s Studies dashboards.

New Feature: sIRBs and SMs Can Close Sites in IREx

Approvals, Coordinator, Edit Participating Sites, Email Notifications, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, September 2021, Status Summary Tab, Study PI

sIRBs and Study Managers can now close sites on studies. A reason or reasons for closure, date of closure, and determination letter are required to post a site closure. Closing a site sends a notification to the site’s HRPP and study team members and archives all past approvals so that no documents can be downloaded. Participating sites continue to have access to site closure documentation for 30 days after a site closure is submitted, after which the site cannot access the study in IREx. A listing of closed sites is available to sIRBs and Study managers on the Status Summary tab. For further information, see the Site Closure Quick Guide.