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).
Category Archives: FRL
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. |
New Feature: Capture any reliance agreements in IREx.
SIRBs can now use IREx to track broad or study-specific reliance agreements, such as an IRB Authorization Agreement (IAA) or MOU, for sites who are unable to join SMART IRB. These reliance agreements can be designated as “broad” – to be used across multiple studies – or “study specific” – for use on a single study only. An sIRB can offer both SMART IRB plus another reliance agreement on the same study; when this happens, Relying Institutions that are part of SMART IRB will automatically default to using SMART IRB so no additional tracking is needed.
Updated Feature: SIRBs can now track study-specific indemnification.
SIRBs have been able to track the use of broad indemnification agreements, such as Letters of Indemnification (LOIs), since February 2019. Now, SIRBs can utilize IREx to track study-specific indemnification agreements. When indemnification is required on a study, an “Indemnification” column will appear on the Status Summary tab, and Relying Institutions will be unable to rely until the SIRB indicates the indemnification agreement has been executed.
Updated Feature: SIRB Liaisons have “Agreement Manager” on the Status Summary tab.
When an IAA, MOU, or other institution-specific reliance agreement or indemnification agreement is offered by the SIRB on a study, an “Agreement Manager” appears on the Status Summary tab for the SIRB. The sIRB uses the Agreement Manager to track the agreement status of Relying Institutions on a study. The sIRB can indicate which Relying Institutions will use their reliance and/or indemnification agreements and track when agreements are sent and executed.