Category Archives: November 2019

Updated Feature: Getting Started Checklist Revamped

Coordinator, Frequently Asked Questions, FRL, Getting Started Checklists, November 2019, Relying HRPP, Status Summary Tab, Study PI

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

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.