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.
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.
Institutions wishing to complete or make iterative updates to their Institutional Profile can now press “Save & Return Later” to publish what was completed or updated without having to complete the entire profile. This helps make it easier for HRPPs to make quick updates.
| Fixed: Ensured all study teams can access documents on Study-wide Approvals tab. |
| Fixed: Multi-site Liaison Reviewing IRB study counter |
| Fixed: Bug preventing sites and studies from listing correctly on the IREx website. |
The Study Dashboard for Reviewing IRBs now includes an IRB number column. Reviewing IRB Liaisons can sort studies according to IRB number in addition to study title, number of participating sites, number of approved sites, expiration date, and next step. This was a request from IREx users, as sIRBs often use IRB numbers to quickly identify studies and organize their tasks.
The Study Dashboard for Participating Sites has also been upgraded. It now includes a PI column. Participating Site HRPPs can sort studies by PI name in addition to study title, reviewing IRB, expiration date, and next step. This was a request from IREx users, as HRPPs can more easily identify a study based on the PI name than study title.
| Fixed: Missing signatures on HRP and PI surveys |
| Fixed: Invalid user emails cannot be entered |
| Fixed: Updated training links on IREx portal homepage |
In the past, the Reviewing IRBs had to contact an IREx Administrator in order to edit an existing approval (e.g., add/correct an approval document). Reviewing IRB Liaisons are now able to do so at any time. When an approval is edited, an email will notify Relying HRPP Liaisons and study team personnel specifying the changes made. This feature makes it easier for Reviewing IRBs to correct information on IREx while also maintaining clear communications about changes.
In December, IREx added a PDF of the site-specific SSRP to the Local Considerations export. Now, the SSRP PDF is available for download from the Status Summary tab when you click on the Reliance Decision for a site. This is an additional way to review details of a site’s SSRP for a study. The name of the file includes the participating site’s name.
The site contacts (e.g., PI or Coordinator) listed by the Study Manager will auto-fill as members of the study team when the Participating Site HRPP registers for a study. This allows the HRPP Liaison to confirm existing contacts, rather than having to re-enter the contact information. After the HRPP liaison has registered and confirmed the contacts, they receive access to IREx and the study. After a site has registered, the PI and Coordinator information is locked to the Study Managers, so the site edits personnel if needed.
