When uploading the Initial study approval for a relying site, Reviewing IRBs and Study Managers will notice the “Is Site Enrolling?” question has been updated to, “Will Site Enroll Participants?”. This ensures Reviewing IRBs and Study Managers mark ‘Yes’ when uploading the initial approval for sites had not started enrollment. However, for Study-wide amendments and Continuing reviews, this question will remain the same.
Category Archives: Approvals
New Feature: Study elements history stored on Approvals tab
IREx will store the study elements history on the Approvals tab, next to the approval/review type. The study elements history can be used by anyone with study access to view which study elements were indicated and apply to the study per approval.
Updated Feature: Allow to turn off site amendment approval notifications
Reviewing IRBs and Study Managers now have an option to check a box to turn off the email approval notification and updates for site amendments.
New Feature: Reviewing IRBs can enable turning off approval notifications
To give more flexibility to Reviewing IRBs and Study Managers in their communication with study teams, IREx now allows for approval notifications to be turned OFF on a study-by-study, approval-by-approval basis. A new question in the IREx Setup, “Would you like to allow turning off study notifications?” lets Reviewing IRBs enable this feature and allow turning off IREx approval notifications and updates for the lead site/overall study and relying sites. Turning off notifications can be useful when making corrections (date correction, updated document) to an existing approval.
Updated Feature: Allow users to Replace Draft protocol documents until approval is published
When Reviewing HRPPs or Study Managers are uploading their approval documents, they must either ‘Accept’ the draft protocol or ‘Replace Draft.’ They can use the Replace Draft button to replace the protocol as many times as they need until the approval has been published. They still must ‘Accept’ the protocol before they can publish.
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.
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: Amendment Application in IREx no longer required
The amendment application is no longer required when uploading a study-wide and site-specific amendments in IREx.