The My Relying Studies Report (CSV) on the Participating Site Dashboard export has a new ‘auto Approved’ column to indicate whether the site’s approval was automatically when publishing the lead site’s approval. The column will show a value of ‘1’ if the site’s approval was automatically posted, which means the site did not have site-specific changes. A ‘0’ indicates the site’s approval was uploaded separately from the overall approval because it contained site-specific changes (e.g., updated or re-stamped consent forms).
Category Archives: Relying HRPP
New Feature: Streamlined Local Considerations documentation for HRPPs
IREx has simplified local considerations documentation by no longer requiring Relying HRPPs to upload their locally verified site-specific ICF(s) to the HRP Survey. Now, Coordinators or Investigator can upload the locally verified ICF(s) to the PI Survey for the sIRB to review. HRPPs are also no longer required to validate their site’s responses to the PI Survey; however, responses can still be viewed and edited, if needed.
New Feature: Investigators are notified when edits are made to the PI Survey
Investigator will receive an email notification when Relying HRPPs and Coordinators make edits to the PI Survey. Investigator must attest every time edits are made to the PI Survey.
New Feature: Relying HRPPs and Investigator are no longer required to verify study team access
The Getting Started Checklist for Relying HRPPs and Investigator no longer requires verifying study team access. If a Study Manager adds a site Coordinator when initially adding the site to a study, that Coordinator now gets access to IREx when the Relying HRPP registers for the study in IREx, rather than waiting for the Relying HRPP or Investigator to verify their access. Relying HRPPs and Investigator have the optional step to “Add/ Edit Study Team Access” as needed.
New Feature: Relying HRPPs receive a reminder when steps are incomplete, and the Investigator attests to the PI Survey
Relying HRPPs will receive an email notification, “Local Considerations reminder”, if they still have incomplete steps when the Investigator attests to the PI Survey. Incomplete steps include: Indicate Reliance, Confirm Institutional Profile, and Complete HRP Survey.
Updated Feature: The Participating Site Dashboard “To Do” list has been updated to reflect steps no longer required
The ‘Verify Study Team Access’ and ‘Validate PI Survey’ steps will no longer show on the Participating Site Dashboard’s “To Do” column. Those steps are no longer required for Relying HRPPs.
Updated Feature: Protocol document not included in the sort filter
On both the Study-wide IRB Approvals and the Approval History tab, the protocol is now pinned at the top of documents and not included if sorted. This is to help make it easier for users to find the protocol after sorting.
Updated Feature: Column header on the Participating Site Export is renamed
In the Participating Site Export, the column header, “dateInitialReviewApproved” is renamed to “dateLeadSiteInitialApproval” to help differentiate the date of initial approval for the Lead Site from relying sites.
Updated Feature: FWA short name is displayed on the Approval History tab when component sites are listed on a study
For clarity, a site’s FWA short name and full component site name will show in the ‘View As’ menu of the Approval History tab for sIRBs, Study Managers, and HRPPs overseeing multiple FWAs on a study.
New Feature: Filter on the Approval History tab
The filter option on the Approval History tab allows users to filter approvals by review type such as, Amendments and Continuing Reviews. The filters help users easily find an approval shared by the sIRB.