Study managers will now be cc’d on the email reminder sent out when a study is nearing the expiration date listed in IREx. This email notification serves as a reminder to upload the continuing review approval to IREx to ensure the approval statuses for sites stay up-to-date. The email also now includes a hyperlink to the quick guide for uploading continuing reviews.
Category Archives: Approvals
Bug Fixes – January 4, 2021
| Fixed: Download All button works for approvals with large volume of documents |
Updated Feature: Improved Getting Started Checklist for Study Managers Uploading Approvals
As of March 2020, Study Managers can upload Continuing Reviews and Study-Wide Amendments on behalf of the sIRB. This month we improved their Getting Started Checklist to avoid some confusion. The steps “Upload Overall Study Approval” and “Publish Approval” disappear from the checklist once Study Managers have done these steps, so they know they are complete for that review and the next step is to upload approval for relying sites
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: Enhanced Status Type When Uploading Approvals for Study Managers and sIRBs
The approvals upload page has been enhanced to better highlight the study’s approval status (approved vs. pending) for sIRBs and Study Managers. The new page layout is more intuitive, showing the status as the first question.
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: Enhanced Versions Box
The Approvals Versions box, located on the left-hand bar of a study page, has been enhanced so that studies with numerous sites can easily view SIRB approvals sorted by Relying Sites and sites who are Registered/In Progress. In addition, the Approvals Versions box now features a scroll bar so users can quickly navigate to view a site’s approval status.
New Feature: sIRBs are no Longer Required to Upload Overall Approval for Continuing Reviews & Study-wide Amendments
To further streamline the work of the sIRB in IREx and avoid delays in posting approvals, the Study Manager can now post the overall/lead site approval for continuing reviews and amendments. In the past, the sIRB had to upload this before the Study Manager could upload approvals for Relying Sites. Now, this is a single process that can be completed by the Study Manager.
The sIRB is now only required to create the study and post the overall study or lead site approval initial approval. Thereafter, all approval documents are managed by the Study Manager.
New Feature: Editing Approvals Always Unlocked for Reviewing IRBs
In the past, the Reviewing IRBs had to contact an IREx Administrator in order to edit an existing approval (e.g., add/correct an approval document). Reviewing IRB Liaisons are now able to do so at any time. When an approval is edited, an email will notify Relying HRPP Liaisons and study team personnel specifying the changes made. This feature makes it easier for Reviewing IRBs to correct information on IREx while also maintaining clear communications about changes.
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.”