| Enhanced: We have added a new Complete Agreements step to the Relying HRPP Getting Started Checklist that will show what agreements are required to rely on the Reviewing IRB for the study. Relying HRPP Liaisons will need to complete the required agreements before they can indicate reliance for a study. |
| Enhanced: We have added clarification text to the Complete IREx Setup window to clarify which local considerations module to use when a study does not require consent forms. |
Category Archives: FRL
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.
Bug Fixes – February 18, 2019
Fixed: We have added a character counter to the Amendment Summary text box to show the maximum character limit for the text box.
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.
System Enhancements – December 10, 2018
Enhanced: Reviewing IRB Liaisons and IREx Study Managers can now list a site coordinator to be notified in addition to the PI and Participating Site HRPP when a site is added to a study in IREx.
Bug Fixes – December 10, 2018
| Fixed: We have added help text in Edit Participating Site window for Study Managers and Reviewing IRBs to explain how PIs and coordinators get access to IREx. As a reminder, Participating Site Study Teams get access from their local HRPP, after their HRPP has accessed the study |
| Fixed: We have updated IREx to default all initial protocol documents as draft documents until the Reviewing IRB is ready to publish their approval. |
| Fixed: Based on a suggestion from our User Feedback Group, we have added a newsletter archive to our website with links to and short descriptions of past IREx newsletters. |
New Feature: IREx Portal Agreement No Longer Required
As of November 7, 2018, the IREx Portal Agreement is no longer required to join IREx! Instead, new institution’s HRPP or IRB directors or mangers can request access via the link on the IREx Members Page. For current IREx members, all users will see electronic Terms of Use the first time they login after November 7th. The Terms of Use replace the portal agreement. We hope this will streamline and shorten the onboarding process for new sites using IREx.
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.