IREx Study Managers and Reviewing IRB Liaisons can download a CSV export of the Status Summary Tab for each study. On the Status Summary Tab, click Export Data > Export Status Summary Tab to download the data displayed on the Status Summary Tab.
Category Archives: Reviewing IRB
New Feature: Introducing Indemnification Tracking in IREx
IREx now supports Letter of Indemnification (LOI) Tracking. The LOI is a unique agreement between the Reviewing IRB and participating institutions concerning indemnification and related terms, if required, when using the SMART IRB Agreement. Both Reviewing IRBs and Participating Sites can use IREx to easily track the status of their LOI agreements. Reviewing IRBs can track which institutions have signed their LOI and, if they choose to, store the executed agreements in IREx. Participating Sites can view which LOIs they have signed for other institutions.
System Enhancements – February 18, 2019
Enhanced: We have added help text in the IREx Project Settings window for Reviewing IRB liaisons to explain why Reviewing IRB liaisons cannot be listed as IREx Study Managers. As a reminder, liaisons already have IREx Study Manager privileges for all studies at their institution and do not need to be designated for each study.
New Feature: See Who Has Access to Your Study in IREx
Reviewing IRB Liaisons and IREx Study Managers can now view or download a list of Participating Site Personnel that have access to their studies in IREx. On the study page, click “Participating Personnel” above the study title to view the list.
New Feature: Manually Notify HRRPs and Investigators About Your Study in IREx
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
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.
New Feature: Institutional Profiles Download is Publicly Available
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.
New Feature: IRB Dashboards
IRB Dashboards provide a snapshot of an IRB Liaison’s studies and next steps in IREx — helping Reviewing IRBs and Participating Site HRPPs/IRBs manage their studies.
There are two dashboards: one for studies where your site is the Reviewing IRB and another showing when your site is listed as a Participating Site. On each, the last column on the dashboard shows the Liaison’s next step, if any are outstanding. The dashboards are sortable by any column, and clicking on the To Do will take you to the study where you can complete the step.
New Feature: Downloadable Study-Specific Reliance Plan (SSRP)
As requested, the Study-Specific Reliance Plan (SSRP) is now included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP. Participating Site HRPPs can also download a PDF of the SSRP from the site-specific info button on a given study.
Update: Status Summary Now Includes Dates of HRPP Activity
To better inform the Reviewing IRB and Coordinating Center / Lead Study Team, the Status Summary Tab now tracks when Participating Site HRPPs 1) are “contacted” about a study in IREx, 2) “start” the reliance process by accessing the study in IREx and, 3) “complete” their cede decision in IREx.