Feature: Download a Report of Your Status Summary Tab
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.
Users Impacted: IRB liaisons, Coordinating Center Staff, Lead Study Teams
Summary of Major Bugs/ System Enhancements
- Enhanced: IRB liaisons can click the components button to see which studies their FWA components are listed on. As a reminder, liaisons can add and remove FWA components at any time as long as they are not listed on an existing study.
Users Impacted: IRB Liaisons
- Enhanced: We have improved our user interface to speed up the study page load time for larger studies with several participating sites.
Users Impacted: All
Feature: New IREx Study Manager Dashboard
IREx Study Managers have a new Study Manager Dashboard that gives an at-a-glance summary of their studies in IREx. For each study, the dashboard shows Study Managers how many participating sites have 1) registered, 2) completed each of the required agreements, 3) indicated reliance, 4) completed all local considerations (if applicable), and 5) received approval for the current version. The dashboard is color-coded, and each counter will turn green when all the participating sites listed on the study have completed that step.
Users Impacted: Coordinating Center Staff, Lead Study Teams
Summary of Major Bugs/ System Enhancements
- 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.
Users Impacted: IRB Liaisons
- 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.
Users Impacted: IRB Liaisons
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.
Users Impacted: IRB Liaisons
Summary of Major Bugs/ System Enhancements
- 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.
Users Impacted: IRB Liaisons
- Enhanced: We have added help text to the Participating Personnel window to describe when Participating Site Study Teams get access to a study in IREx. As a reminder, Participating Site Study Teams get access from their local HRPP, after their HRPP has accessed the study.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
- Fixed: We have added a character counter to the Amendment Summary text box to show the maximum character limit for the text box.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
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.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
Summary of Major Bugs/ System Enchancements
- 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.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
- 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.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
- Fixed: We have updated IREx to default all initial protocol documents as draft documents until the Reviewing IRB is ready to publish their approval.
Users Impacted: IRB Liaisons
- 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.
Users Impacted: All
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.
Users Impacted: All
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.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
Feature: Manually Notify HRPPs 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.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
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.
Users Impacted: IRB Liaisons
Summary of Major Bugs/ System Enhancements
- 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
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
- 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.
Users Impacted: IRB Liaisons
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.
Users Impacted: IRB Liaisons, IRB Users
Summary of Major Bugs/ System Enhancements
- 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.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
- 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.
Users Impacted: All
- 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.
Users Impacted: IRB Liaisons
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.
Users Impacted: IRB Liaisons, IRB Users
Summary of Major Bugs/ System Enhancements
- Fixed: Institution full names are now displayed in the site approvals window, on the Status Summary Tab and on the Relying Site Approvals Tab to reduce confusion when uploading and accessing approval documents for sites with similar acronyms.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
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.
Users Impacted: IRB Liaisons, Study Teams
Summary of Major Bugs / System Enhancements
- Fixed: The Status Summary Tab has been updated to better distinguish component site reliance progress as distinct from the FWA holder.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
- Fixed: IREx has been updated to allow the Lead Study Team to export local context on studies where there are no coordinating center staff listed.
Users Impacted: Study Teams
Update: Status Summary Now Includes Dates of HRPP Activity
To better info 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.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
Summary of Major Bugs / System Enhancements
- Fixed: For study-wide amendments and continuing reviews, the Reviewing IRB determination letter and dates of submission, review and approval for the lead site / overall study are copied over to Participating Site approvals to expedite the upload process for Reviewing IRBs or Coordinating Centers / Lead Study Teams.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
Feature: Downloadable Documentation of Reliance Letter
A PDF of the Official Documentation of Reliance Letter is now available as a download on the Site-Specific Info button on a given study. Participating Site HRPPs can also access this PDF from the Study-Specific Reliance Plan view. Click Site-Specific Info> View Reliances (SSRP)> Letter of Reliance. As always, the letter will continue to be included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP.
Users Impacted: IRB Liaisons
Update: Verifying the Participating Site Contact List Document
To help Participating Sites identify their site PI, IREx has updated the Edit Participating Sites window to require the Reviewing IRB or Coordinating Center / Lead Study Team to upload an updated participating site contact list document whenever a new site is added.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
Summary of Major Bugs / System Enhancements
- Enhanced: IREx will send an email notification to the Participating Site HRPPs when the Reviewing IRB makes edits to the study specific reliance plan (SSRP) to reflect any site-specific changes requested.
Users Impacted: IRB Liaisons
- Fixed: To reduce email traffic for Participating Sites, study expiration notices will no longer be sent to the Participating Site HRPPs and Study Teams. Instead, one notice will be sent to the Reviewing IRB Liaisons at 90, 60, 30 and 7 days to expiration or until a new approval is uploaded.
Users Impacted: IRB Liaisons
Update: Aligning the IREx Study-Specific Reliance Plan with the SMART IRB Agreement Implementation Checklist and Documentation Toolkit
IREx’s Study-Specific Reliance Plan (SSRP) was harmonized with the SMART IRB Agreement Implementation Checklist and Documentation Toolkit, which documents how the Reviewing IRB and Participating Site HRPPs will handle any flexible elements of the reliance agreement such as auditing, SOPs, insurance, external reporting, etc. This does not impact existing reliance relationships. The updated SSRP will only appear for studies created on or after April 25.
Users Impacted: IRB Liaisons
Feature: Local Context Module 2
IREx released a second local considerations module to accommodate studies where consent documents are created by the Reviewing IRBs / Coordinating Centers. In this new module, Participating Sites will enter their local consent language directly into IREx as they would like it to appear on the consent form. Then, the final consent document will be generated on behalf of Participating Sites by the Reviewing IRB or Coordinating Center. Additionally, this new local context module provides a CSV download of all survey responses.
Users Impacted: IRB Liaisons, Study Teams
Summary of Major Bugs / System Enhancements
- Fixed: IREx now allows PIs to make changes to the PI survey even after it has been completed as long as it has not been validated the HRPP Liaison. HRPP Liaisons can also edit completed PI surveys as long as the site has not received approval from the Reviewing IRB. If changes are made, the Lead Study Team / Coordinating Center is also notified of the changes.
Users Impacted: IRB Liaisons, Study Teams
- Fixed: IREx now allows Participating Site HRPPs to make changes to local considerations surveys even after they have been completed as long as the site has not received initial approval from the Reviewing IRB. If changes are made, the Lead Study Team / Coordinating Center is also notified of the changes.
Users Impacted: IRB Liaisons
- Fixed: IREx has updated the Participating Sites window to better identify sites that do not have access to IREx. These sites are labeled “Not in IREx” and colored grey in the Edit Participating Sites window.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
- Fixed: IREx has separated the “Add Study Contacts” step from the “Edit Review” step to allow study teams to be added before the study is ready for approval.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
Update: SMART IRB Exchange becomes IRB Reliance Exchange (IREx)
We are excited to announce that we are transitioning SMART IRB Exchange to a new name: IRB Reliance Exchange (IREx). We hope this new name helps clarify that IREx is a tool used to facilitate the single IRB review process that is distinct from, but can be used with, the SMART IRB Agreement.
Users Impacted: All
Summary of Major Bugs / System Enhancements
- Fixed: The Institutional Profile has been updated to allow up to 15 component sites to be individually listed.
Users Impacted: IRB Liaisons, IRB Users
- Fixed: IREx has updated the site review window to require minimal risk categories only when a minimal risk study is reviewed by expedited review.
Users Impacted: IRB Liaisons
- Enhanced: Links to the IREx Resources page and to the IREx trainings sign up are now available under the resources section of the home page. As always, the link to the Resources page is also available on the top right of every page in IREx.
Users Impacted: All
- Enhanced: For study-wide amendments and continuing reviews, the Reviewing IRB review dates for the lead site / overall study are copied over to Participating Sites approvals to expedite the upload process.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Lead Study Teams
Feature: Capture Study-Specific Local Context from Participating Sites
IREx released a local context/local considerations module to allow Reviewing IRBs to centrally capture study-specific local considerations for each site, using standardized surveys and questions aligned with national sIRB initiatives.
The local considerations module has two surveys: 1) The Human Research Protections (HRP) survey asks about requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local site ancillary reviews, relevant to the specific study or trial that would affect the conduct or approval of the research at your institution, as well as the consent form for this study. This is completed by the Participating Site HRPP Liaison; and 2) the PI survey asks about the conduct of the study at your site and is completed by the Participating Site PI. The Participating Site HRPP must verify the PI survey responses.
Users Impacted: IRB Liaisons, Study Teams
Feature: Getting Started Checklists
IREx released user-specific checklists (“Getting Started Checklists”) on each study to help IRBs and study teams navigate their reliance-related steps. The checklists are role-specific and auto-hide once all the steps have been completed for a given study.
Users Impacted: IRB Liaisons, Study Teams
Summary of Major Bugs / System Enhancements
- Enhanced: IREx now allows multiple draft documents to be uploaded during study creation. Drag and drop multiple documents or select all to upload simultaneously.
Users Impacted: IRB Liaisons
Feature: Subscribe To Our YouTube Channel
IREx launched a YouTube channel to host short system demonstration videos. You can also subscribe to our YouTube channel to stay in the know on new features.
Users Impacted: All
Summary of Major Bugs / System Enhancements
- Fixed: The Site Approvals window has been updated to highlight any tabs with missing information or errors for the Reviewing IRB or Study Manager. This should help reduce errors and premature approval notification emails.
Users Impacted: IRB Liaisons
Update: Access your Approval Documents Directly in IREx
The IREx approval notification will no longer attach approval documentation to the new approval notice email. Instead, each email will contain a link to the study page where all the appropriate documents are available. This ensures that all approval emails deliver on time and are not delayed due to file size. This is also an improved security measure to ensure that only current / active study team members have access to the documents.
Users Impacted: Study Teams
Summary of Major Bugs / System Enhancements
- Enhanced: IREx has added warning text and pop-up windows to all actions that trigger automatic email notifications to facilitate better communication from Reviewing IRBs to Participating Sites. These pop ups will identify who will be emailed and provide steps for what to do if you do not wish to send a notification immediately.
Users Impacted: IRB Liaisons, Coordinating Center Staff
- Enhanced: To help participating site HRPPs identify their local investigator / study team contacts, IREx now requires a Participating Site contact list document for studies where Participating Sites are listed. This document can be updated when new sites are added to the study.
Users Impacted: IRB Liaisons, Coordinating Center Staff
- Fixed: To facilitate accurate documentation of sites engaged in research, IREx now allows FWA components to be listed ona study independently from their primary FWA holding institution. If a component and the FWA holder have separate study teams participating on the same study, both can be listed, provide separate cede decisions, and have approval documents provided independently.
Users Impacted: IRB Liaisons, Coordinating Center Staff
Summary of Major Bugs / System Enhancements
- Fixed: Liaison and study team access to approval documents is now restricted to only documents associated with their institution. Multi-site Liaisons and Liaisons of FWA components can see and download documents for all the FWA institutions and components they manage.
Users Impacted: IRB Liaisons, Coordinating Center Staff, Study Teams
- Enhanced: IREx allows IRB/ HRPP Liaisons to deactivate users at their institutions who no longer need access to IREx. To deactivate an account, search for the user on the Find Other Users page; click the user name to open the edit user window; change the user status to inactive; and click save.
Users Impacted: IRB Liaisons
- Enhanced: IREx now attaches the Participating Study Team Quick Guide to all new study invitation emails sent to study teams. This quick guide outlines how Participating Site Study Teams can provide access for other study team members and how to access and download approval documents.
Users Impacted: Study Teams
- Enhanced: IREx now allows the Reviewing IRB Liaisons to update the protocol version name when replacing a draft protocol with a final approved version.
Users Impacted: IRB Liaisons
- Fixed: We updated the Participating Site approvals interface to carry forward sites that ceded review on a previous version, but have not yet been approved on the most current version. This enhances the version control to ensure the Participating Site initial review is associated with the correct version of the protocol.
Users Impacted: IRB Liaisons, Coordination Center Staff
Feature: New Coordinating Center Staff Role
IREx has created a new user role called the coordinating center staff (CC Staff). This role is assigned by the Reviewing IRB Liaison. The CC Staff is typically the coordinating center contact or a member of the Lead Study Team who is responsible for managing Participating Sites in IREx.
CC Staff have the ability to add or remove sites to the study and upload approvals for Participating Sites as they are received. These users also have access to the Status Summary Tab to track Participating Sites through the reliance process until they are ready for sIRB review.
Users Impacted: IRB Liaisons, Coordinating Center Staff / Lead Study Team Members
Summary of Major Bugs / System Enhancements
- Enhanced: A link to the IREx Terms of Use is now available on the IREx login page.
Users Impacted: All
Feature: Multi-site Liaisons for users overseeing multiple FWAs
IREx supports institutions that oversee or provide HRPP functions for multiple FWAs using the Multi-Site Liaison feature. IRB/HRPP Liaisons can be set up as “Multi-Site Liaisons” to manage multiple FWAs with one user account. Multi-Site Liaisons can easily manage Institutional Profiles for each FWA, as well as indicate reliance and access approval documents each FWAs, even within a single study, in IREx. Contact the IREx team to be set up as a multi-site Liaison.
Users Impacted: IRB Liaisons
Feature: New Status Summary Tab
The Status Summary Tab provides an overview of status of all Participating Sites listed on a study. Use this tab to track each site’s progress towards sIRB review as they sign on to the required agreements to begin reliance and indicate reliance on the Reviewing IRB. This tab is available to the Reviewing IRB Liaisons and Lead Study Team Members.
Users Impacted: IRB Liaisons, Lead Study Team
Summary of Major Bugs / System Enhancements
- Enhanced: We have made major revisions to our IREx notifications to ensure they provide relevant information and details on next steps required in the reliance process.
Users Impacted: All
Feature: Find and List FWA Component Sites on a Study
IREx supports affiliated institutions that are listed as component sites on an FWA. Components do not have separate accounts in IREx. Instead, their access is managed by the FWA holder’s Liaison(s) and share an Institutional Profile with the FWA-holding institution. IRB Liaisons can manage their FWA components using the components button on the IREx homepage. To list a component site on a study, the Reviewing IRB or Study Manager can search for components by name or FWA number using the Add a Site box in the Edit Participating Site window.
Users Impacted: IRB Liaisons
Summary of Major Bugs / System Enhancements
- Enhanced: Reviewing IRB Liaisons and IREx Study Managers can list individual Participating Sites on a study in IREx without creating a network or consortium.
Users Impacted: IRB Liaisons
Feature: Official Documentation of Reliance Email
IREx sends an official documentation of reliance email to the Reviewing IRB Liaisons, Participating Site HRPP Liaisons and Study Team Members.
This email is sent after the Participating Site HRPP Liaison has accepted the Reviewing IRB’s study-specific reliance plan (SSRP). A PDF of the letter of reliance is attached to this email.
Users Impacted: IRB Liaisons, Study Teams
Feature: Add draft documents on study creation
IREx allows Reviewing IRB Liaisons to upload draft documents such as draft protocols and informed consent documents during study creation. These documents are visible on the Reviewing IRB approvals tab to all Participating Sites and are labeled as drafts. Users receive a pop-up warning before they download the documents letting them know that the documents have not yet been approved by the sIRB.
Users Impacted: IRB Liaisons, Study Teams
Feature: sIRBs that are not participating research sites on a study
IREx has been updated to support scenarios where the Reviewing IRB institution is not a participating research site or is not the lead site for a given study. During study creation, the sIRB can now indicate whether or not they are a participating site.
Users Impacted: IRB Liaisons
Feature: Add New Sites not in IREx
Reviewing IRB Liaisons can use the Add a Site button on the Edit Participating Sites window to list additional sites on their studies in IREx. Reviewing IRB Liaisons can also type in the institution name if they are not already listed in IREx and the IREx team will add the institution as a site to IREx (note: the site must still be onboarded to get access to IREx).
Users Impacted: IRB Liaisons
IREx Initial Launch
The IRB Reliance Exchange (formerly known as SMART IRB Exchange) is a freely available, web-based portal that supports single IRB review documentation and communication for multicenter clinical trials. IREx is available to any institution with an FWA and can be used to document and support reliance for any study using reliance.
Users Impacted: All