Fixed: We have added a character counter to the Amendment Summary text box to show the maximum character limit for the text box.
Category Archives: FRL
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.
Bug Fixes – October 31, 2018
| 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
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
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.