Category Archives: FRL

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.

Updated Feature: Add a consortium of sites to studies in the Participating Sites Dialog

Edit Participating Sites, FRL, Getting Started Checklists, IREx Study Manager, June 2021

The first step for Study Managers on IREx is to add participating sites. This step has been made easier for consortium studies with the “select consortium of sites” option. Inform the IREx Administrators if you would like to establish a consortium. Once created, the SM can simply add all sites from a consortium at once. Sites can also be removed; plus, non-consortium sites can be added to any study in addition to consortium sites.

Updated Feature: Email notification includes helpful guidance when new sites added

Edit Participating Sites, Email Notifications, FRL, IREx Study Manager, June 2021, Relying HRPP, Reviewing IRB

When a site that has not joined IREx is listed on a study, the “Participating Sites Added to Study” email now includes helpful text to guide how the site HRPP/IRB can initiate access for their site through the Join IREx page. This is an existing email sent to Reviewing IRBs and SMs if either party adds new sites to a study, but now updated for clearer guidance.