TThe Study Registration page has been updated to give Participating Site HRPPs control of how their site is listed on a study. The new registration page allows the HRPP Liaison to confirm the site and PI listed, change the PI for your site, indicate that a different site is engaged by the PI, add additional FWAs for a single study team (“Combo Site”), or decline engagement in a study. Please visit our YouTube channel to watch a video on the new Study Registration process. Please visit our YouTube channel to watch a video on the new Study Registration process.
Category Archives: Relying HRPP
Updated Feature: Institutional Profile now allows Save & Return Later feature
Institutions wishing to complete or make iterative updates to their Institutional Profile can now press “Save & Return Later” to publish what was completed or updated without having to complete the entire profile. This helps make it easier for HRPPs to make quick updates.
Updated Feature: PI Name Added to Participating Site IRB Dashboard
The Study Dashboard for Participating Sites has also been upgraded. It now includes a PI column. Participating Site HRPPs can sort studies by PI name in addition to study title, reviewing IRB, expiration date, and next step. This was a request from IREx users, as HRPPs can more easily identify a study based on the PI name than study title.
Updated Feature: Single Entry of Team Personnel Added by Study Manager
The site contacts (e.g., PI or Coordinator) listed by the Study Manager will auto-fill as members of the study team when the Participating Site HRPP registers for a study. This allows the HRPP Liaison to confirm existing contacts, rather than having to re-enter the contact information. After the HRPP liaison has registered and confirmed the contacts, they receive access to IREx and the study. After a site has registered, the PI and Coordinator information is locked to the Study Managers, so the site edits personnel if needed.
New Feature: Email Notifications for Updated Approvals
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.”
New Feature: Lead Site Display
For some studies, the institution serving as the Reviewing or Single IRB (sIRB) is not the lead site for the study. To distinguish roles and provide greater specification, IREx now allows the sIRB to identify a Lead Site. This information will be displayed in the first tab in IREx, now called the “Study-wide Approvals Tab”.
Updated Feature: Getting Started Checklist Revamped
Some steps of the HRPP Getting Started Checklist can be edited after you have completed them. To make this clearer, we added a pencil icon to those steps. HRPPs will see a pencil next to Add/Edit Study Team, Confirm Institutional Profile, Complete HRP Survey, and Validate PI Survey. We also added a “See Status Summary” link on the participating site HRPP and study team Getting Started checklists to provide quick access to the Status Summary tab, which is now available to all participating sites on a study.
Updated Feature: Updates to Status Summary Export
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
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: Up to Date IREx Resources
It has been a busy season in IREx with many updates, so the resources below now reflect the new features.