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.
Category Archives: System Enhancements/ Bug Fixes
System Enhancements – May 31, 2018
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.
Bug Fixes – May 31, 2018
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.
Bug Fixes – April 25, 2018
| 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. |
| 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. |
| 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. |
| 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. |
Bug Fixes – March 14, 2018
| Fixed: The Institutional Profile has been updated to allow up to 15 component sites to be individually listed. |
| Fixed: IREx has updated the site review window to require minimal risk categories only when a minimal risk study is reviewed by expedited review |
System Enhancements – March 14, 2018
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.
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.
System Enhancements – February 5, 2018
Enhanced: IREx now allows multiple draft documents to be uploaded during study creation. Drag and drop multiple documents or select all to upload simultaneously.
Bug Fixes – December 20, 2017
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.
System Enhancements – November 13, 2017
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.
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.
Bug Fixes – November 13, 2017
Fixed: To facilitate accurate documentation of sites engaged in research, IREx now allows FWA components to be listed on a 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.