Category Archives: IREx Study Manager

New Feature: The ‘Onboarding’ Tab is now available on all studies

May 6, 2024Coordinator, FRL, IREx Study Manager, May 2024, Relying HRPP, Reviewing IRB, Study PI

Previously called the ‘Documents’ tab, the ‘Onboarding’ tab is an easily accessible place for Relying Sites to find any additional documents (i.e., Reviewing IRB SOPs, Reviewing IRB Communication Plans, Part 2 Consent Forms) that were uploaded by the Reviewing IRB or Study Manager to help facilitate sites’ local submission process.

Reviewing IRBs and Study Managers can upload additional documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.

Relying Sites that do not have initial approval will default to the Onboarding tab when accessing the study page. Relying sites will be able to access these documents, along with their sIRB instructions, for the life of the study.

New Feature: Amendment Content can now be indicated when uploading a study-wide amendment

February 13, 2024Approvals, February 2024, FRL, IREx Study Manager, Local Considerations, Reviewing IRB

For studies capturing local consideration updates, Reviewing IRBs and/or Study Managers will see a new ‘Amendment Content’ section on the Add Study-Wide Amendment dialog. The content areas are informed by the SMART IRB local considerations guidance documents.

Updated Feature: Display site(s) listed on the study on the ‘Add Site’ dialog

January 4, 2024Edit Participating Sites, FRL, IREx Study Manager, January 2024, Reviewing IRB

From the Sites tab, the ‘Add Site’ dialog will now display a list of sites already listed on the study. This will serve as a quick glance to help the user reference what sites are already listed when adding new sites.

Updated Feature: SS Tab Export: Capture Date Requested Agreements

December 12, 2023December 2023, FRL, IREx Study Manager, Reviewing IRB, Status Summary Tab

The “Request Agreement Date” is now in the Status Summary Tab Export. The export will list only the first/original date requested agreements for a site. The Reviewing IRB and IREx Study Manager can access the export from the Status Summary Tab.

New Feature: Allow to resend ‘Request Agreements’ notification

November 7, 2023Agreements/ Reliance, Email Notifications, FRL, IREx Study Manager, November 2023, Reviewing IRB, Status Summary Tab

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: Allow to add contacts from the Contacts page

November 7, 2023FRL, IREx Access, IREx Study Manager, November 2023, Reviewing IRB

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 Study Manager Getting Started Checklist

November 7, 2023FRL, Getting Started Checklists, IREx Study Manager, November 2023

The IREx Study Manager’s Getting Started Checklist has a new ‘Request Agreements’ step. This step lets the Study Manager know they can send a notification to request sites’ complete the required study agreements. Also, the ‘Grant Site Access’ step now displays a pop-up with helpful information on granting sites access.

Updated Feature: Renamed ‘Add Site Coordinator Access’ from the Approval History tab

November 7, 2023Coordinator, FRL, IREx Access, IREx Study Manager, November 2023, Reviewing IRB, Study PI

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

October 2, 2023FRL, IREx Study Manager, October 2023, Reviewing IRB

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.

October 2, 2023Edit Participating Sites, FRL, IREx Study Manager, October 2023, Reviewing IRB

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.