A new email notification, ‘IREx Update: Community Consultation Plan Accepted and Next Steps’ is to notify study teams when the sIRB has accepted their CCP and to initiate the plan. The notification will also include next steps for the principal investigator and study contacts on reporting the plan’s results.
Category Archives: Email Notifications
New Feature: New notification when site completes CCP Summary of Results Survey
A new email notification, ‘IREx Update: Site’s CCP Summary of Results Survey Complete’ is sent to the Lead Study Team/Study Managers to notify them a site has completed the required CCP Summary of Results Survey for an EFIC study. The sites’ status will display 4/4 surveys completed on the Status Summary tab. Study Managers can download uploaded documents from the local considerations export.
Updated Feature: Modified ‘IREx Access and Single IRB Instructions’ email for EFIC study
The ‘IREx Access and Single IRB Instructions’ email is modified for an EFIC study in IREx. The modified email includes instructions for local study teams to work with their local HRPP to develop a site-specific Community Consultation Plan (CCP).
Update Feature: Updated the sIRB Instructions to reference the ‘Onboarding’ tab
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.”
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.