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.
Category Archives: IREx Study Setup
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.
New Feature: Lead Site Display
For some studies, the institution serving as the Reviewing or Single IRB (sIRB) is not the lead site for the study. To distinguish roles and provide greater specification, IREx now allows the sIRB to identify a Lead Site. This information will be displayed in the first tab in IREx, now called the “Study-wide Approvals Tab”.
Updated Feature: Protocol Version
When creating a study or adding an amendment, a version name is required for the protocol. The “Protocol Version” field has been relabeled as “Protocol Date and/or Version” to clarify that users should enter the version number as entered on the protocol, which is often a date. In IREx trainings, users have also been encouraged to enter the amendment number in the summary of changes so that it is reflected on IREx and on email notifications sent out when changes are made.
New Feature: Indicate “No Further Review Required” for Qualifying Studies
In line with the revised Common Rule, IREx now allows sIRBs to indicate “No Further Review Required” and NOT enter an expiration date for studies that no longer require continuing review (more here). For studies where this feature is used, sites will no longer have an expiration date listed in IREx and the IREx approval notifications will direct site investigators to refer to the approval letter from the sIRB and their local HRPP for ongoing reporting requirements.
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: 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.
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.
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.