Sites receive the sIRB instructions in the “IREx Access and Single IRB Instructions” email when they are notified about the study. The purple text on the sIRB Instructions has been updated to say, “The overall/lead site approval is available in IREx on the Approvals tab of the study page. Use the Onboarding tab to view any additional documents shared by the sIRB and/or lead study team. Use these documents to prepare your local submission and initiate the reliance process at your site.”
Category Archives: Email Notifications
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.
New Feature: Annual reminder to update Institutional Profile (IP) sent to HRPPs
IREx will now send an annual reminder to IREx Liaisons (IRB/HRPP personnel) from the date the institution last updated their Institutional Profile. The reminder is to encourage HRPPs to keep their IP up to date as state laws or institutional policies may change.
New Feature: Allow to resend ‘Request Agreements’ notification
Reviewing IRBs and Study Managers can resend the Request Agreements notification to sites with incomplete agreements. From the Status Summary’s Agreement column, use the drop down and press ‘Request Agreements’ to resend a notification. The button and pop-up will show the last date the request agreement notification was sent for the site.
Updated Feature: Site Coordinators will now be cc’d on emails to the PI
Coordinators will now be included on email notifications to the PI except for the PI’s access and login email.
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.