The new IP question, “Do you have local instructions for investigators when relying on another IRB?” will now be included on the IP CSV download.
Category Archives: IREx Study Setup
New Feature: IREx now supports Exception from Informed Consent (EFIC) studies
IREx now supports studies using the EFIC process. Using IREx to implement your EFIC workflow helps lead study teams track sites in various stages of the EFIC process; standardizes and centralizes EFIC documentation for the sIRB and relying HRPPs; and provides sites with clear EFIC processes and approval statuses. When setting up the study, Reviewing IRBs can select EFIC as an option in the IREx Setup. Study team can now upload their local Community Consultation Plan (CCP) to IREx’s PI Survey and Relying HRPPs can confirm review of the local CCP in the HRP Survey. After the sIRB reviews and accepts the site’s CCP, Study Managers can share the Reviewing IRB’s acceptance of the site’s local CCP to IREx and to begin implementing the plan. Watch this video and read this announcement to learn more.
New Feature: Reviewing IRBs can now request Relying Sites update their Local Considerations throughout the life of a study
In the IREx Study Setup, Reviewing IRBs/sIRBs can choose to have IREx notify relying sites when a study-wide amendment is posted, and request sites update their local considerations in IREx if necessitated by the study changes. If sIRBs choose this option, they can also opt to choose a number of days sites have to submit their updates in IREx. This feature is only available on studies in which the sIRB is collecting local considerations in IREx.
New Feature: Reviewing IRBs can now upload additional documents to share with sites
Reviewing IRBs can now indicate in the IREx Setup if they’d liked to provide additional documents to help facilitate the site’s local submission process. This question is found on the SIRB Instructions tab of the IREx Setup and defaults to ‘No.’ If selecting ‘Yes,’ the Reviewing IRB will be required to upload additional documents and a new ‘Documents’ tab will appear on the study page for all users to access the additional documents.
New Feature: IREx provides tailored Agreement and Single IRB Instructions for sIRB studies
Single IRBs can now use IREx to provide tailored instructions to relying sites, significantly reducing administrative burdens and accelerating research timelines. When completing the IREx Setup, Single IRBs can include site instructions for:
- Executing Required Agreements: Instructions for executing the necessary agreements between the Single IRB and relying sites. No more one-size-fits-all approaches – adapt the instructions to communicate the agreement requirements for your study.
- Completing the Single IRB Process: Guide relying sites through the single IRB process with clear and concise instructions for both the relying site HRPP and study teams.
Note: After the sIRB confirms the instructions in the IREx setup, sIRBs or lead study teams (“IREx Study Managers”) can use the Status Summary page to send the instructions to sites.
New Feature: How-to videos are embedded in the IREx Setup on Agreements tab.
Two videos are embedded in the IREx Setup on the “Agreement” tab to help sIRBs know (1) what agreements can be offered on a study and how to add them and (2) how to offer a non-SMART IRB Agreement to an existing study.
New Feature: Capture any reliance agreements in IREx.
SIRBs can now use IREx to track broad or study-specific reliance agreements, such as an IRB Authorization Agreement (IAA) or MOU, for sites who are unable to join SMART IRB. These reliance agreements can be designated as “broad” – to be used across multiple studies – or “study specific” – for use on a single study only. An sIRB can offer both SMART IRB plus another reliance agreement on the same study; when this happens, Relying Institutions that are part of SMART IRB will automatically default to using SMART IRB so no additional tracking is needed.
New Feature: Tracking Combo Sites Now Supported in IREx
Combo Sites, defined as one study team engaging multiple FWAs for the same study, are now supported on IREx. In the past, SIRBs and Study Managers had no way to group sites together to ensure all documentation was in place before review. Moreover, relying sites had to duplicate information (e.g., PI Survey). Now, Combo Sites are marked with a blue link icon throughout IREx and have several features to ensure reliance documentation is completed by each FWA in the most streamlined way possible. For more information, please visit our resources page, organized by role on our menu toolbar and watch our Combo Site trailer on YouTube.
Updated Feature: Study Registration Redesigned and Questions Added for Participating Sites
TThe Study Registration page has been updated to give Participating Site HRPPs control of how their site is listed on a study. The new registration page allows the HRPP Liaison to confirm the site and PI listed, change the PI for your site, indicate that a different site is engaged by the PI, add additional FWAs for a single study team (“Combo Site”), or decline engagement in a study. Please visit our YouTube channel to watch a video on the new Study Registration process. Please visit our YouTube channel to watch a video on the new Study Registration process.
Updated Feature: Redesigned Participating Sites Dialog for Study Managers and sIRBs
The Participating Sites Dialog, used by the SIRB or Study Manager to add participating sites to a study, has a new intuitive design. Here, a site can be added with the PI and/or Coordinator information. If the PI or coordinator is an existing IREx user, their information will be auto-filled. You can also add additional FWAs if one study team engages multiple FWAs (“Combo Site”). Please watch our 3-minute YouTube video to learn more about adding sites to a study.