Two videos are embedded in the IREx Setup on the “Agreement” tab to help sIRBs know (1) what agreements can be offered on a study and how to add them and (2) how to offer a non-SMART IRB Agreement to an existing study.
Category Archives: April 2021
Updated Feature: Agreement Checker includes other Broad Reliance Agreements.
The Agreement Checker, which can be accessed from the IREx homepage after logging in, has been updated to reflect whether relying sites have executed any non-SMART reliance agreements with the selected single IRB. The Agreement Checker also reflects whether relying sites have executed a broad indemnification agreement with the selected single IRB. Study-specific agreements are not reflected in the Agreement Checker since execution of those agreements cannot count towards other studies.
Updated Feature: PI Checklist includes help text to guide PI through steps.
Relying Site PIs have a checklist to guide them through their required steps in IREx – verifying local study team access and completing their PI Survey. The checklist now includes hover text that appears if they have skipped a step, and a pencil icon beside steps that can be edited (i.e., the PI Survey before the HRPP has validated the survey).
Updated Feature: Study Manager Getting Started Checklist better reflects expected tasks.
The Study Manager (SM) is typically responsible for ensuring participating sites document all reliance and local review information for the sIRB. To help facilitate this documentation, “Track Site Progress on Status Summary” is now a discrete step on the SM’s Getting Started Checklist and it routes the SM to the Status Summary Tab when clicked. Additionally, Study Managers will now see a pencil icon beside “Add Participating Sites” and “Add PI Info” since this information can be updated at any time.
Updated Feature: Study Manager Dashboard includes additional information.
For easier and quick reference, the Study Manager Dashboard now includes the IREx Project ID, which is also at the end of all IREx URLs for the study. Additionally, the Study Manager Dashboard now includes the most recent study approval date and the expiration date.
Updated Feature: An 8-digit FWA is now required when listing a new site that does not exist in IREx on the Participating Site dialog.
Occasionally an sIRB or Study Manager adds a site to their study that does not yet exist in IREx (i.e., the site does not pop-up when typing their name). The FWA number will be required to add this site to IREx, as this information helps ensure the institution has an active FWA, which is the minimum standard for participating. A link to the OHRP FWA database is provided for reference.
Updated Feature: Participating Sites Dialog distinguishes whether site has joined IREx.
In order to help sIRBs and Study Managers know they need to request a site join IREx before the site can provide reliance and local review documentation in IREx, the Participating Sites dialog will now include the following text for sites that have not signed the IREx Terms of Use:
Let this site know their HRPP/IRB needs to initiate IREx access for their site here.
Updated Feature: Continuing Review reminder notification cc’s Study Managers and clarifies what action is needed.
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.
Bug Fixes – April 2, 2021
| Fixed: Study Manager and SIRB are cc’d on all site approval emails when multiple sites are uploaded at once; not just first site approval email. |
| Fixed: The email “Time to upload Continuing Review to IREx” includes the PI if the PI is also the Study Manager. |
| Fixed: The publish approval checkbox is reinstated on the upload approvals dialog for the lead site. |
| Fixed: New Study Managers receive a temporary password email when their account is created. |
| Fixed: When searching for studies, spaces entered in the search box are persevered generating proper search results. |
| Fixed: A validated PI Survey no longer says the HRPP needs to validate it. |
| Fixed: Blank boxes are removed from the Site-specific Approvals tab. |
| Fixed: The versions box includes links to site-specific amendments, when needed. |
| Fixed: Hide the multisite liaison dashboard (“Your Sites” tab) when the Liaison is acting as the sIRB. |
| Fixed: sIRBs and Study Managers can now break/delete combo sites from the Participating Sites dialog. |