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.
Category Archives: Reviewing IRB
Updated Feature: Allow to add contacts from the Contacts page
Reviewing IRBs and Study Managers can now use the ‘Edit Study Team Access’ button on the Contacts page to give access to additional contacts at sites with study access.
Updated Feature: Updated Reviewing IRB Getting Started Checklist
Reviewing IRBs now have a ‘Create Study’ step on their Getting Started Checklist. Clicking the step opens the ‘Edit Study’ dialog that allows the Reviewing IRB to make changes to the study title, short title, study summary, NCT#, and sponsor information.
Updated Feature: Renamed ‘Add Site Coordinator Access’ from the Approval History tab
The ‘Add Site Coordinator Access’ menu option on the Approval History tab, has been renamed to ‘Add Study Team Access’. The Reviewing IRB and Study Managers can now give additional or new PIs access to the study using the ‘Add Study Team Access’ dialog at any time. Previously, they were only able to give coordinators access.
New Feature: Capture study teams’ first and last access study dates
The Contacts page now displays the ‘First Access’ and ‘Last Access’ columns. The Reviewing IRBs and Study Managers can see when study team contacts’ first and last date accessed the study page. This information can also be downloaded using the ‘Download CSV’ button.
Updated Feature: Display engaged combo sites when editing site contacts.
Editing contacts for a combo site that has not been given study access will now show all engaged sites in the combo and can be modified.
Updated Feature: Display closed sites on the Sites page
sIRBs and Study Managers can now see if a site was closed on the Sites page.
Updated Feature: Amendment Application in IREx no longer required
The amendment application is no longer required when uploading a study-wide and site-specific amendments in IREx.
New Feature: IREx provides tailored Agreement and Single IRB Instructions for sIRB studies
Single IRBs can now use IREx to provide tailored instructions to relying sites, significantly reducing administrative burdens and accelerating research timelines. When completing the IREx Setup, Single IRBs can include site instructions for:
- Executing Required Agreements: Instructions for executing the necessary agreements between the Single IRB and relying sites. No more one-size-fits-all approaches – adapt the instructions to communicate the agreement requirements for your study.
- Completing the Single IRB Process: Guide relying sites through the single IRB process with clear and concise instructions for both the relying site HRPP and study teams.
Note: After the sIRB confirms the instructions in the IREx setup, sIRBs or lead study teams (“IREx Study Managers”) can use the Status Summary page to send the instructions to sites.
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.