Approval Documents in both Study-wide and Site-specific IRB approval tabs now include a “date uploaded” column and are sorted by ascending uploaded date. Now it is clearer which documents have been carried forward from past approvals and which documents are new.
Category Archives: Study PI
Updated Feature: Agreement Checker includes other Broad Reliance Agreements.
The Agreement Checker, which can be accessed from the IREx homepage after logging in, has been updated to reflect whether relying sites have executed any non-SMART reliance agreements with the selected single IRB. The Agreement Checker also reflects whether relying sites have executed a broad indemnification agreement with the selected single IRB. Study-specific agreements are not reflected in the Agreement Checker since execution of those agreements cannot count towards other studies.
Updated Feature: PI Checklist includes help text to guide PI through steps.
Relying Site PIs have a checklist to guide them through their required steps in IREx – verifying local study team access and completing their PI Survey. The checklist now includes hover text that appears if they have skipped a step, and a pencil icon beside steps that can be edited (i.e., the PI Survey before the HRPP has validated the survey).
Updated Feature: New Document Types on Approvals
Document types are used in IREx to help manage files associated with a study’s approval. For clarification, IREx has renamed Consents to Consents & Assents, and added document types for Grant Application, Measures, Recruitment & Advertisements, and Other IRB Approved Documents. The new categories will make it easier for users on IREx to find their study documents.
Updated Feature: Redesigned Resources Pages
We updated the Resources pages for logged in members so that helpful documents, like user manuals, are easier to find. The IREx Resource Pages are divided by user type and can be accessed from the top menu using the “Resources” link from on any page, or on the right side of the homepage. As a bonus, the pages are more visually pleasing.
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: PI Checklist Now Includes Study Team Step
When a PI logs into IREx, they see their Getting Started Checklist on the left-hand side of the screen. A new first step has been added: Add/Edit Study Team. Any study team members added by the Study Manager or Reviewing IRB are listed in the dialog. The PI can confirm these members and/or add additional PIs and Coordinators in this step. Team members entered by the Study Manager or the Reviewing IRB will not have access to the study on IREx until the PI confirms this dialog. This new step facilitates participating study teams’ access to IREx.
New Feature: Email Notifications for Updated Approvals
A new email notification is now sent when any existing approval – for the overall study or a participating site – is updated. For example, if additional documents are uploaded or exchanged, an email will notify the relying site’s HRPP and study team personnel of the revisions and the exact changes are detailed in a table. The notification will bring clarity to the email notifications and ensure sites are aware of updates or changes to their approval, as specified in section 5.9 of the SMART IRB Agreement, “Notification of IRB Decisions, Changes, Lapses in Approval.”
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: Getting Started Checklist Revamped
Some steps of the HRPP Getting Started Checklist can be edited after you have completed them. To make this clearer, we added a pencil icon to those steps. HRPPs will see a pencil next to Add/Edit Study Team, Confirm Institutional Profile, Complete HRP Survey, and Validate PI Survey. We also added a “See Status Summary” link on the participating site HRPP and study team Getting Started checklists to provide quick access to the Status Summary tab, which is now available to all participating sites on a study.