After local considerations are completed, additional information or clarifications may be necessary from relying sites. IREx has always notified the sIRB and Study Manager when Local Considerations are updated. Now, this notification will include a detailed table outlining the changes that were made to each survey.
Category Archives: FRL
Updated Feature: Updates to Status Summary Export
IREx helps manage Letters of Indemnification (LOIs) for institutions that require them when serving as the sIRB. On a given study, the sIRB can track whether or not a site has signed their LOI on the Status Summary tab and the Status Summary Export. Now, the Status Summary export will also include the date participating sites signed the LOI. Additionally, the Status Summary export has been updated so that the date of initial approval is always included. The export still includes the most recent approval date, if there are approvals beyond the initial approval.
Updated Feature: Renamed Tabs
You will notice some rewording of the study page tabs. The first, blue tab is now titled Study-wide IRB Approvals (before called “Reviewing IRB Approvals”) because these documents are relevant to all sites. The second, orange tab is now titled Site-specific IRB Approvals (before called “Relying Site Approvals”) because it captures documents for each site. Both tabs retain the same functions as before but are more appropriately named.
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.
Updated Feature: Up to Date IREx Resources
It has been a busy season in IREx with many updates, so the resources below now reflect the new features.
Bug Fixed – November 4, 2019
| Fixed: Institutional Profile now correctly exports the responses to multiple checkbox answers |
| Fixed: Expiration dates were one day off in the Reviewing IRB and Participating Site HRPP Dashboards |
| Fixed: Search boxes now search by full study title and short name |
New Feature: Participating Sites can View Status Summary
Participating Site HRPPs and Study Teams now have a new tab “Status Summary” tab where they can visualize their site’s progress completing the steps towards sIRB approval. This tab is view only – no actions are completed on the tab. Participating Site HRPPs and PIs will continue to complete their steps on the Getting Started Checklist, which also has a navigation link to the Status Summary called “View Status Summary”. This feature is expected to bring transparency and clarity to participating sites as their HRPPs and study teams works towards reliance.
Updated Feature: Tracking Changes to the Local Considerations HRP Survey
The Human Research Protections (HRP) Survey and PI Survey are key parts of capturing local considerations. When Participating Site HRPPs edit the PI or HRP Survey, an email notification is now sent to the Study Manager indicating what was changed on the survey. This feature is expected to help ensure Study Managers distinguish what was changed and ensure their requested changes were made appropriately.
Updated Feature: Enhanced PDF Export of Local Considerations Surveys
Local considerations received another enhancement this month: PDF Exports of the surveys now include embedded HRPP Liaison and PI signatures, respectively, rather than including the signatures as separate files. These surveys record important study-specific information and support national sIRB initiatives.
Updated Feature: Modified Continuing Review Documentation for Studies Closed to Enrollment
Although studies that are designated as Greater than Minimal Risk (GTMR) require consent forms, IREx now allows for the input of GTRM Continuing Reviews that are reviewed via the expedited review process. A consent form is no longer a required document for these reviews to better facilitate, for example, studies that are closed to enrollment. This change helps accommodate nuances of different phases of study conduct.