Some sites on studies are ‘engaged in research’, but they aren’t consenting participants. The question, “Is Site Enrolling?” is now added to the Overall Study/ Lead Site and Relying Site Approvals dialog. The sIRB and Study Manager can now mark when a site is not enrolling. The “Site Not Enrolling” indicator will be shown on the Study-wide IRB Approvals Tab for the lead site and for a site’s published approval. All sites marked as not enrolling will not require a consent form for upload. When a new approval version is created, the site’s enrollment status will carry forward and can be updated as needed.
Category Archives: IREx Study Manager
Updated Feature: Remove Requirement to Name Document Prior to Upload for Lead Site Approval
For lead site approvals, the requirement to enter a description when uploading documents for Other IRB Approved Documents, Others, and Package Insert has been removed. The Reviewing IRB and Study Manager have the option to edit the name for those document types after upload.
Updated Feature: Add descriptive text in Comment Bubbles for Sites
To clarify the Comment bubble function on the Status Summary tab, the button “Post” is now changed to “Save” when saving a comment. Descriptive text is also added in the Comment bubble dialog:
“Log and share internal notes with the Reviewing IRB Liaisons and Study Managers. No notifications are sent when a comment is posted.”
Updated Feature: The upload Continuing Review Notification includes Additional Guidance
The “Time to upload Continuing Review to IREx” email, sent to the sIRB and Study Manager, now includes updated guidance on uploading a study closure if the study is no longer active.
Updated Feature: Search box now searchable by FWA number on the Find other sites page and Agreement checker
Users accessing the ‘Find other sites’ page and ‘Agreement checker’ can now search a site by FWA number in addition to the site name.
Updated Feature: Allow a Site Closure for Sites Not Approved for a Current Version but have Initial Approval
Previously, sites can only be closed on a study if the site has approval on the current version. The sIRB and Study Managers will now have the [+ Add Site Closure] option for sites that have received initial approval, even if they are not approved on the current study version. The Sites Closed page will list the version that the site had their last approval.
Updated Feature: ICF and option to “Waive” consents are no longer required for Minimal Risk Studies
If a study is minimal risk, regardless of whether the submission type was Full or Expedited, the sIRB and Study Manager are not required to upload a consent document for the overall study approval and for relying site approvals. The waiver box does not have to be checked.
Updated Feature: More Flexible Combo Site Documentation
A Combo Site occurs when one study team engages multiple Federalwide Assurances (FWAs) for a given study. Because sIRBs often review and approve Combo Sites separately – so as not to delay study activation at one site – IREx has added new flexibility for Combo Sites.
Most importantly, sites in a Combo can now be reviewed and approved by the sIRB separately. To facilitate sites being reviewed by the sIRB as quickly as possible, the notification that local considerations have been completed for a site in a Combo is now sent to Study Managers and sIRBs instantly, rather than requiring all sites be complete. Additionally, after a site is reviewed and approved by the sIRB, the site’s approval can be posted to IREx instantly, rather than requiring all sites in the Combo to have approval before the documents can be posted. Given that combo sites may have separate consent forms or receive approval at separate times, combo site approvals are posted for each FWA/site, like the other sites on the study.
Updated Feature: TIN Study Emails Identified
All emails for studies that are part of the Trial Innovation Network (TIN) now include the sentence “This study is part of the TIN” for added clarity and searchability.
Updated Feature: Clarified Pop-up when Removing Site Amendments
A Study Manager or sIRB can delete an erroneous Site Amendment by clicking on Remove Site Amendment on the Site-specific IRB Approvals tab and confirming the removal. The confirmation pop-up has been updated to inform the user that sites will not be notified when the Site Amendment is deleted.