Category Archives: Reviewing IRB

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: 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.

New Feature: sIRB Can Close Studies on IREx

Approvals, August 2021, Coordinator, Dashboard, Email Notifications, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, Status Summary Tab, Study PI

sIRBs can now close studies that are complete on IREx by uploading the reason and date of closure, as well as the IRB determination letter. Closing a study notifies sites that the study has ended. The study remains accessible to all registered sites after a closure is posted, and all past approvals become read-only. A record of sites’ reliance details and a history of sIRB site approvals are still available in all IRB exports for metrics. For instructions on how to close a study, see our Quick Guide.

Here is what you will see for a closed study:

  • Study page is grayed out with a Study Closed header at the top
  • Status Summary Tab shows as Closed in Approval column
  • IRB Dashboards show that a study has been closed
  • Versions box shows that a study has been closed
  • Exports show closed studies with date of closure

New Feature: Data exports for sIRBs and Relying Site HRPPs

Agreements/ Reliance, Approvals, Dashboard, FRL, June 2021, Relying HRPP, Reviewing IRB

sIRB and HRPP liaisons can now export a csv file to quickly view and analyze data for studies, including dates for registration, reliance, and approvals. The sIRB can utilize the export to evaluate processes and assess efficiency (time to approval) and workload (number of relying sites). Relying HRPPs can also export data to efficiently view all studies in which they are participating, the SIRBs serving for those studies, and dates for registration, reliance, and approvals. Access this feature through the top righthand side of both Reviewing Site’s Studies and Participating Site’s Studies dashboards under “Exports.”

Updated Feature: Capture additional timepoints during Lead & Relying Site Approvals

Approvals, FRL, IREx Study Manager, June 2021, Local Considerations, Relying HRPP, Reviewing IRB

When capturing Lead and Relying Site Approvals, the sIRB and SM can now capture additional timepoints in the review process, such as the date the sIRB requested changes from PI and when those changes were received. Additional IRB review dates can also be captured if a study required multiple reviews. Local Review dates have been moved to the HRP survey for studies capturing Local Considerations to streamline the date capture. Local review dates have been removed for studies not capturing Local Considerations, since those sIRBs have chosen to track local considerations outside of IREx. The Status Summary Tab export, Reviewing Site Dashboard export, and Participating Site dashboard include these additional fields. These additional dates are optional but may help in achieving a more granular timeline of the sIRB review process.

Updated Feature: Enhancements to sIRB and Participating Studies Dashboards

Dashboard, FRL, IREx Study Manager, June 2021, Relying HRPP, Reviewing IRB

Filters have been added to Reviewing Site’s Studies and Participating Site’s Studies dashboards to refine the studies viewed. The sIRB can filter their Reviewing Site’s Studies to only view Ongoing Studies, hiding studies where all sites have a current approval. Furthermore, IRBs/HRPPs in the Trials Innovation Network (TIN) can filter by TIN Only studies and non-TIN only studies.

The Participating Site Dashboard now shows the Local IRB Number, which is an optional field on the HRP survey filled out by the Relying Site HRPP. This same number can also be viewed in the Site-Specific Approvals tabs.

The Participating Site Dashboard now shows the date the IRB approved the site under “To Do”

These enhancements were added for quick viewing and efficient searching.

Updated Feature: Enhancements to the Agreement Checker

Agreements/ Reliance, FRL, IREx Study Manager, June 2021, Relying HRPP, Reviewing IRB

The Agreement Checker is a helpful tool on the IREx homepage which helps see if potential sites have already executed reliance and broad indemnification emails for a selected sIRB. We have made enhancements to make this tool easier to use and more visually appealing. There is added informational text explaining that sites are only required to execute one reliance agreement offered on a study, even if they have executed multiple. The SMART 1, SMART 2, and Other Reliance columns have been shaded to show that all are considered a reliance agreement. The Other Reliance Agreement and Indemnification columns have been updated with an easy-to-spot ✔️check mark symbol. The csv export includes the full FWA number.