The sIRB liaison(s) for a study will receive an email notification when the study manager has published the Overall Study/Lead Site Initial Approval. The subject line of this notification reads, “FYI: Overall Initial Approval Uploaded to IREx”. All study managers are also CC’ed on this email. No action steps are associated with this notification.
Category Archives: Email Notifications
New Feature: sIRB is notified after Study Manager publishes any Study-wide Approval
sIRB liaisons receiving notifications for a study will receive an email notification when the study manager has published any study-wide approval (e.g., Continuing reviews and study-wide amendments) in IREx. The subject line of this notification reads “FYI: Overall Approval Uploaded to IREx”. Study managers are also copied on this email. The email will list the type of approval and provide a link to the study. No action steps are associated with this notification.
New Feature: Investigators are notified when edits are made to the PI Survey
Investigator will receive an email notification when Relying HRPPs and Coordinators make edits to the PI Survey. Investigator must attest every time edits are made to the PI Survey.
New Feature: Study Managers receive a notification when the Investigator attests to the PI Survey
Study Managers will receive an email notification, “PI Survey Completed – Available for Prescreen”, the first time an Investigator at a site has attested to the PI Survey. This is so the Study Managers can go do a quality assurance check and ask for necessary edits, if desired.
New Feature: Relying HRPPs receive a reminder when steps are incomplete, and the Investigator attests to the PI Survey
Relying HRPPs will receive an email notification, “Local Considerations reminder”, if they still have incomplete steps when the Investigator attests to the PI Survey. Incomplete steps include: Indicate Reliance, Confirm Institutional Profile, and Complete HRP Survey.
New Feature: SIRBs and Study Managers can Resend Study Notification to Sites
The sIRB and Study Manager can now re-notify/contact a site about a study by resending the “IREx study at your site” notification. This is done by clicking the site’s ‘Contacted’ status from the Status Summary tab. The subject line of the email notification will include the sender’s name who is re-contacting the site (e.g., “Jane Smith is resending your IREx Study Notification”). This feature is used to follow up with sites that have not yet started on the study.
New Feature: An email notification is sent to the PI when a new coordinator is added at their site.
When a sIRB or Study Manager gives a site coordinator access to their study, an email notification, “New Coordinator Added” is sent to the PI. The email lists the study title, the sIRB Liaison or Study Manager who added the coordinator, site name, new coordinator name and email, and link to the study.
New Feature: Amendment number included on approval notifications
The Amendment number and description, if provided by the sIRB or Study Manager, will be included in the table of the approval notification email sent to relying site HRPPs and study teams.
Updated Feature: Approval notifications include new Approvals Quick Guide
All relying site approval notifications are updated to include text and a link to the Approvals Quick Guide for helping study teams locate their approval documents:
“*NEW* We’ve made accessing your approval documents more user friendly – use this Quick Guide to see changes.”
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.