Coordinators will now be included on email notifications to the PI except for the PI’s access and login email.
Category Archives: Email Notifications
New Feature: Grant Relying Site Study Teams Immediate IREx Access
IREx now automatically grants the relying site study teams access to the platform when their site is notified of a study. Study team contacts receive login credentials and can log in immediately to view study details, access the sIRB initial approval documents, and collaborate with the lead study team. Study teams no longer have to wait for their Human Research Protection Program (HRPP) administrators to log in and confirm access – minimizing unnecessary waiting periods. However, the relying HRPP must confirm study participation before the study team can complete the PI Survey.
Reviewing IRBs and Lead Study Teams (“IREx Study Managers”) can use the Status Summary page in IREx to notify sites and grant study teams access to the study.
Updated Feature: Include multiple study team contacts before notifying sites of a study
Lead Study Teams can now enjoy the flexibility of including multiple study team contacts before notifying sites of a study. IREx allows Lead Study Teams to list multiple investigators and/or ‘coordinators’ for each site involved in the study. This comprehensive approach enables you to include a diverse range of key personnel, such as regulatory specialists, clinical research associates, clinical research navigators, and more. Having multiple study team contacts enhances collaboration by keeping everyone informed, engaged, and up-to-date throughout the site onboarding process.
New Feature: sIRB is notified after Study Manager publishes Overall Study/Lead Site Initial Approval
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.
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.