Lead Study Teams and Coordinating Center Staff will now be called “IREx Study Managers”. IREx Study Managers play a vital role in tracking Participating Sites’ as they navigate the reliance process. The new IREx Study Manager Checklist outlines how Study Managers can manage their Participating Sites, manually notify site HRPPs and PIs of the study in IREx, export Local Considerations for submission to the sIRB and upload Participating Sites approval documents to IREx. IREx Study Managers should be sure to talk to the Reviewing IRBs about how they plan to leverage this role to support the study in IREx.
Category Archives: FRL
New Feature: Institutional Profiles Download is Publicly Available
The IREx Institutional Profiles (IPs) are now publicly available for download as a PDF on the IREx Members Page of the public website. The new PDF will include a time-stamp for the date the IP was last updated.
The IREx IP contains basic information about an institution that others can use to determine if they feel comfortable relying on, or serving as the Reviewing IRB for, that institution. In addition to creating greater transparency among HRPPs and IRBs, making the IPs publically available will facilitate and streamline the single IRB process by making information more readily available. Moreover, this fosters high-quality information sharing between institutions.
Bug Fixes – October 1, 2018
| Fixed: IREx has streamlined the site amendment workflow to allow Reviewing IRB Liaisons and IREx Study Managers to complete a site amendment in one step. Site amendments are used to upload a change to a single, approved site, such as a PI change. Use the site amendment button located next to the site name on the Relying Site Approvals Tab to add site amendments. |
| Fixed: The IREx public website members page was not listing Liaisons associated with multiple institutions (Multi-site Liaisons). Multi-site Liaison contact information now appears for all sites. |
| Fixed: Approval documents for component sites were not visible to IRB Liaisons at the FWA-holding institutions. IRB Liaisons can now access all documents for all FWA components. |
New Feature: IRB Dashboards
IRB Dashboards provide a snapshot of an IRB Liaison’s studies and next steps in IREx — helping Reviewing IRBs and Participating Site HRPPs/IRBs manage their studies.
There are two dashboards: one for studies where your site is the Reviewing IRB and another showing when your site is listed as a Participating Site. On each, the last column on the dashboard shows the Liaison’s next step, if any are outstanding. The dashboards are sortable by any column, and clicking on the To Do will take you to the study where you can complete the step.
Bug Fixes – August 1, 2018
Fixed: Institution full names are now displayed in the site approvals window, on the Status Summary Tab and on the Relying Site Approvals Tab to reduce confusion when uploading and accessing approval documents for sites with similar acronyms.
Bug Fixes – July 21, 2018
| Fixed: The Status Summary Tab has been updated to better distinguish component site reliance progress as distinct from the FWA holder. |
| Fixed: IREx has been updated to allow the Lead Study Team to export local context on studies where there are no coordinating center staff listed. |
New Feature: Downloadable Study-Specific Reliance Plan (SSRP)
As requested, the Study-Specific Reliance Plan (SSRP) is now included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP. Participating Site HRPPs can also download a PDF of the SSRP from the site-specific info button on a given study.
Update: Status Summary Now Includes Dates of HRPP Activity
To better inform the Reviewing IRB and Coordinating Center / Lead Study Team, the Status Summary Tab now tracks when Participating Site HRPPs 1) are “contacted” about a study in IREx, 2) “start” the reliance process by accessing the study in IREx and, 3) “complete” their cede decision in IREx.
Bug Fixes – June 19, 2018
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.
New Feature: Downloadable Documentation of Reliance Letter
A PDF of the Official Documentation of Reliance Letter is now available as a download on the Site-Specific Info button on a given study. Participating Site HRPPs can also access this PDF from the Study-Specific Reliance Plan view. Click Site-Specific Info> View Reliances (SSRP)> Letter of Reliance. As always, the letter will continue to be included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP.