IREx now includes a study short name in the subject line of each email to allow users to sort, group and prioritize their emails from IREx.
Category Archives: FRL
New Feature: Include date local considerations surveys were “Updated”
Sometimes Study Managers (SMs) or sIRBs need PSites to make changes to the local considerations they provided in IREx. Before receiving sIRB approval for a study, PSite HRPPs and PIs can make these edits to the Human Research Protection (HRP) and PI surveys (Note: PIs can only make edits before their HRPP validates their answers). IREx will now track when updates were made by the PI or HRPP and include this date on the Status Summary tab so Study Managers can see when the information was last updated.
System Enhancements – May 31, 2019
| Enhanced: IREx requires a determination letter and consent forms (if applicable) be uploaded as part of the Relying Site Approvals. However, IREx also allows for “Other” documents. Study Managers (SMs) can add a label to name the type of document they are uploading. Customizing the types of documents allows for greater specificity and helps better group the documents. |
| Enhanced: When a PSite finishes documenting their local considerations for a study, IREx automatically notifies the SM and sIRB. We updated the text of this email to include language that the SM should pre-screen the information provided in the surveys to ensure the right type of information is provided. If any changes are needed, they can request the PSite edit the local considerations in IREx. The SM and sIRB will also be notified when updates are made. |
Bug Fixes – May 31, 2019
| Fixed: The load time was improved for studies. |
| Fixed: The PDF for Institutional Profiles generated too small when large amounts of text were entered for a question. It now generates in the correct format for printing. |
New Feature: Download a Report of Your Status Summary Tab
IREx Study Managers and Reviewing IRB Liaisons can download a CSV export of the Status Summary Tab for each study. On the Status Summary Tab, click Export Data > Export Status Summary Tab to download the data displayed on the Status Summary Tab.
System Enhancements – April 2, 2019
| Enhanced: IRB liaisons can click the components button to see which studies their FWA components are listed on. As a reminder, liaisons can add and remove FWA components at any time as long as they are not listed on an existing study. |
| Enhanced: We have improved our user interface to speed up the study page load time for larger studies with several participating sites. |
New Feature: New IREx Study Manager Dashboard
IREx Study Managers have a new Study Manager Dashboard that gives an at-a-glance summary of their studies in IREx. For each study, the dashboard shows Study Managers how many participating sites have 1) registered, 2) completed each of the required agreements, 3) indicated reliance, 4) completed all local considerations (if applicable), and 5) received approval for the current version. The dashboard is color-coded, and each counter will turn green when all the participating sites listed on the study have completed that step.
System Enhancements – March 26, 2019
| Enhanced: We have added a new Complete Agreements step to the Relying HRPP Getting Started Checklist that will show what agreements are required to rely on the Reviewing IRB for the study. Relying HRPP Liaisons will need to complete the required agreements before they can indicate reliance for a study. |
| Enhanced: We have added clarification text to the Complete IREx Setup window to clarify which local considerations module to use when a study does not require consent forms. |
New Feature: Introducing Indemnification Tracking in IREx
IREx now supports Letter of Indemnification (LOI) Tracking. The LOI is a unique agreement between the Reviewing IRB and participating institutions concerning indemnification and related terms, if required, when using the SMART IRB Agreement. Both Reviewing IRBs and Participating Sites can use IREx to easily track the status of their LOI agreements. Reviewing IRBs can track which institutions have signed their LOI and, if they choose to, store the executed agreements in IREx. Participating Sites can view which LOIs they have signed for other institutions.
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.