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.
Category Archives: Approvals
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.
New Feature: Streamline Sharing and Notifying Relying Sites of new Continuing Review and Study-wide Amendment Approvals
Relying site approvals no longer have to be individually confirmed after publishing a continuing review or study-wide amendment. Now, if relying sites did not have site-specific changes, their approvals can be confirmed when adding the overall approval so that sites automatically get notified of the Continuing Review or Study-wide Amendment when the overall approval is published.
New Feature: Lead site consents will carry forward on Continuing Reviews if they did not change
Previously, IREx required new consent forms to be uploaded at the time of continuing review. However, when sIRBs do not re-stamp consents at the time of continuing review, a new consent is not approved and therefore a new version should not be uploaded. Now, sIRBs and Study Managers can indicate that the consent(s) was not changed and carryforward the currently approved consent form.
New Feature: Site Updates tab in the Overall Approval dialog is locked after publishing overall approval.
After the overall / lead site approval is published for a Study-wide Amendment or Continuing Review the ‘Site Updates’ tab will be locked. Any modifications to site-specific approvals can be made individually via the Relying Site Approvals dialog.
New Feature: When posting the lead site/overall approval, sIRBs and Study Managers can indicate whether approved sites had site-specific changes at Continuing Review and for Study-wide Amendments on “Site Updates” tab
A new tab – “Site Updates” – has been added when uploading continuing reviews and study-wide amendments. This new tab captures whether any approved sites had site-specific changes as part of the new approval (e.g., updated or newly stamped consent forms). Any enrolling sites that did not have changes are automatically marked as ‘approved’ and notified when the overall / lead site approval is published. The approval for sites with changes must be uploaded after publishing the lead overall / lead site approval.