Category Archives: October 2018

New Feature: Manually Notify HRRPs and Investigators About Your Study in IREx

Email Notifications, FRL, IREx Study Manager, October 2018, Reviewing IRB, Status Summary Tab

IREx now allows Reviewing IRB Liaisons and IREx Study Managers to manually notify sites about their study in IREx instead of automatically emailing sites as soon as they are added to a study. Now sites can be notified at different times if they are being onboarded at different times.

When an IREx Study Managers lists a site on a study, they will enter a PI name and email. The site will appear on the Status Summary Tab. Click the “Notify HRPP” button to notify the site HRPP (and the PI identified) of the study in IREx. This does not give the PI access to IREx. The purpose of this email is to connect the investigator to their local HRPP.

New Feature: Streamlined Study Setup and Notification Preferences

FRL, IREx Study Setup, October 2018, Reviewing IRB

IREx has streamlined how studies are created by Reviewing IRBs. Now Reviewing IRBs can quickly create a study with only four pieces of information: the study title, the sponsor name and a draft protocol and protocol version number.

Reviewing IRBs can also now indicate which of their Liaisons is the “Primary Liaison” for a given study. Other site Liaisons can receive notifications or opt out of all notifications for the study. However, all Liaisons will still have access to the study in IREx, and the Primary Liaison and email preferences can be updated at any time.

Bug Fixes – October 31, 2018

FRL, October 2018, System Enhancements/ Bug Fixes
Fixed: IREx has improved the edit Participating Site search tool so that sites are listed with the FWA holder first followed by component site. This should make it easier to locate and list component sites on a study
Fixed: The term “Local Context” will now be called “Local Considerations” on the Status Summary Tab. Also the study-specific Local Context Survey completed by Participating Site HRPPs will now be called the Human Research Protections (HRP) survey.

New Feature: Introducing: The IREx Study Manager

FRL, IREx Study Manager, October 2018

Lead Study Teams and Coordinating Center Staff will now be called “IREx Study Managers”. IREx Study Managers play a vital role in tracking Participating Sites’ as they navigate the reliance process. The new IREx Study Manager Checklist outlines how Study Managers can manage their Participating Sites, manually notify site HRPPs and PIs of the study in IREx, export Local Considerations for submission to the sIRB and upload Participating Sites approval documents to IREx. IREx Study Managers should be sure to talk to the Reviewing IRBs about how they plan to leverage this role to support the study in IREx.

New Feature: Institutional Profiles Download is Publicly Available

FRL, Institutional Profile, October 2018, Relying HRPP, Reviewing IRB

The IREx Institutional Profiles (IPs) are now publicly available for download as a PDF on the IREx Members Page of the public website. The new PDF will include a time-stamp for the date the IP was last updated.

The IREx IP contains basic information about an institution that others can use to determine if they feel comfortable relying on, or serving as the Reviewing IRB for, that institution. In addition to creating greater transparency among HRPPs and IRBs, making the IPs publically available will facilitate and streamline the single IRB process by making information more readily available. Moreover, this fosters high-quality information sharing between institutions.

Bug Fixes – October 1, 2018

FRL, October 2018, System Enhancements/ Bug Fixes
Fixed: IREx has streamlined the site amendment workflow to allow Reviewing IRB Liaisons and IREx Study Managers to complete a site amendment in one step. Site amendments are used to upload a change to a single, approved site, such as a PI change. Use the site amendment button located next to the site name on the Relying Site Approvals Tab to add site amendments.
Fixed: The IREx public website members page was not listing Liaisons associated with multiple institutions (Multi-site Liaisons). Multi-site Liaison contact information now appears for all sites.
Fixed: Approval documents for component sites were not visible to IRB Liaisons at the FWA-holding institutions. IRB Liaisons can now access all documents for all FWA components.