Category Archives: Reviewing IRB

New Feature: Editing Approvals Always Unlocked for Reviewing IRBs

Approvals, Email Notifications, FRL, January 2020, Reviewing IRB

In the past, the Reviewing IRBs had to contact an IREx Administrator in order to edit an existing approval (e.g., add/correct an approval document). Reviewing IRB Liaisons are now able to do so at any time. When an approval is edited, an email will notify Relying HRPP Liaisons and study team personnel specifying the changes made. This feature makes it easier for Reviewing IRBs to correct information on IREx while also maintaining clear communications about changes.

Updated Feature: Reviewing IRB access to Site-Specific SSRPs PDFs

Agreements/ Reliance, FRL, January 2020, Reviewing IRB, Study-specific Reliance Plan (SSRP)

In December, IREx added a PDF of the site-specific SSRP to the Local Considerations export. Now, the SSRP PDF is available for download from the Status Summary tab when you click on the Reliance Decision for a site. This is an additional way to review details of a site’s SSRP for a study. The name of the file includes the participating site’s name.

New Feature: Email Notifications for Updated Approvals

Approvals, Coordinator, December 2019, Edit Participating Sites, Email Notifications, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, Study PI

A new email notification is now sent when any existing approval – for the overall study or a participating site – is updated. For example, if additional documents are uploaded or exchanged, an email will notify the relying site’s HRPP and study team personnel of the revisions and the exact changes are detailed in a table. The notification will bring clarity to the email notifications and ensure sites are aware of updates or changes to their approval, as specified in section 5.9 of the SMART IRB Agreement, “Notification of IRB Decisions, Changes, Lapses in Approval.”

Updated Feature: Updates to Status Summary Export

FRL, IREx Study Manager, November 2019, Relying HRPP, Reviewing IRB, Status Summary Tab

IREx helps manage Letters of Indemnification (LOIs) for institutions that require them when serving as the sIRB. On a given study, the sIRB can track whether or not a site has signed their LOI on the Status Summary tab and the Status Summary Export. Now, the Status Summary export will also include the date participating sites signed the LOI. Additionally, the Status Summary export has been updated so that the date of initial approval is always included. The export still includes the most recent approval date, if there are approvals beyond the initial approval.

Updated Feature: Renamed Tabs

Approvals, FRL, IREx Study Manager, November 2019, Relying HRPP, Reviewing IRB

You will notice some rewording of the study page tabs. The first, blue tab is now titled Study-wide IRB Approvals (before called “Reviewing IRB Approvals”) because these documents are relevant to all sites. The second, orange tab is now titled Site-specific IRB Approvals (before called “Relying Site Approvals”) because it captures documents for each site. Both tabs retain the same functions as before but are more appropriately named.

Updated Feature: Protocol Version

Approvals, Email Notifications, FRL, IREx Study Setup, November 2019, Reviewing IRB

When creating a study or adding an amendment, a version name is required for the protocol. The “Protocol Version” field has been relabeled as “Protocol Date and/or Version” to clarify that users should enter the version number as entered on the protocol, which is often a date. In IREx trainings, users have also been encouraged to enter the amendment number in the summary of changes so that it is reflected on IREx and on email notifications sent out when changes are made.