| Fixed: Study closure notifications no longer sent to previously participating sites removed from a study. |
| Fixed: Study Managers can now ‘select a site’ from the dropdown on the Add A Contact box to add other Study Managers. |
| Fixed: The “Approved” status on the Status Summary tab is displaying for previously approved sites with edited SSRPs. |
Category Archives: FRL
Updated Feature: Modified Uploading Approval dialog
The Status section of the approval dialog has been modified – moved to the top of the dialog, color changed from grey to blue, is now required, and a new tooltip with the message, “Select Approved if you are ready to share the approval and Pending to save and return later.” This is to ensure that the Reviewing IRB and/or Study Manager marks the Status of the approval they are uploading since in the past it was often missed.
The Type of Study is also now editable at the review level when uploading a continuing review and study-wide amendment.
Updated Feature: Minimal risk categories now displayed if review type is Full board
Previously, when indicating the Type of Study as Minimal Risk, the categories are only displayed if selecting the Review Type as ‘Initial Review: Expedited.’ IREx now displays the Minimal Risk categories whether the review type is Expedited or Full board and is not required.
Updated Feature: Modified column on Participating Site’s Studies Dashboard
The Participating Site’s Studies Dashboard has been updated to help clarify that the local IRB number is noted with the PI name. The PI column is now labeled as, ‘PI (Local IRB #),’ and includes ‘IRB #’ in the column if a local IRB number was indicated by the relying HRPP.
Bug Fixes – March 13, 2024
| Enhanced: Modified UI when indicating a study-wide amendment has a protocol change. |
| Fixed: Amendment # field removed from initial and continuing review approval dialog. |
| Fixed: Relying site notification about updated approval now displaying table of changes. |
| Fixed: Bug breaking ability to create a new site amendment. |
| Fixed: Reviewing IRBs and/or Study Managers cannot Request Agreements if IREx Setup and Primary Study Team Contacts incomplete, to prevent missing information on the notification. |
New Feature: Reviewing IRBs can now request Relying Sites update their Local Considerations throughout the life of a study
In the IREx Study Setup, Reviewing IRBs/sIRBs can choose to have IREx notify relying sites when a study-wide amendment is posted, and request sites update their local considerations in IREx if necessitated by the study changes. If sIRBs choose this option, they can also opt to choose a number of days sites have to submit their updates in IREx. This feature is only available on studies in which the sIRB is collecting local considerations in IREx.
New Feature: Amendment Content can now be indicated when uploading a study-wide amendment
For studies capturing local consideration updates, Reviewing IRBs and/or Study Managers will see a new ‘Amendment Content’ section on the Add Study-Wide Amendment dialog. The content areas are informed by the SMART IRB local considerations guidance documents.
Updated Feature: Modified amendment approval email notification
The amendment approval notification sent to relying sites has been modified for studies capturing local consideration updates for the life of a study. The email subject changed from, “IREx: New IRB Approval For Your Site.” to “ATTN: Approved changes may require local review.” A new Amendment Content section outlines the type of changes and a link on how to edit the surveys is also included.
Updated Feature: Study Reports now shows which studies are capturing Local Consideration updates
The Overall Study and Participating Site Report has a new column, ‘isCapturingLocalContextUpdates’ to indicate which studies in IREx are capturing Local Considerations updates for the life of a study. Reviewing IRBs can download the Overall Study Report (CSV) and the Participating Site Report (CSV) from their Reviewing Site’s Studies Dashboard from the Export menu.
Updated Feature: Relying sites can now edit the HRP and PI Survey after receiving Initial Approval
Prior to February 2024, the HRP and PI Survey was not editable after a relying site received initial approval in IREx. Now, the Relying HRPP can edit both the HRP and PI Survey and the relying site Study Team Members and PI can edit the PI Survey after initial approval, as needed. Editing the surveys in IREx helps align any site changes. IREx will notify the Reviewing IRB and Study Managers when changes to the surveys are made.