Category Archives: FRL

New Feature: Editing Approvals Always Unlocked for Reviewing IRBs

Approvals, Email Notifications, FRL, January 2020, Reviewing IRB

In the past, the Reviewing IRBs had to contact an IREx Administrator in order to edit an existing approval (e.g., add/correct an approval document). Reviewing IRB Liaisons are now able to do so at any time. When an approval is edited, an email will notify Relying HRPP Liaisons and study team personnel specifying the changes made. This feature makes it easier for Reviewing IRBs to correct information on IREx while also maintaining clear communications about changes.

Updated Feature: Reviewing IRB access to Site-Specific SSRPs PDFs

Agreements/ Reliance, FRL, January 2020, Reviewing IRB, Study-specific Reliance Plan (SSRP)

In December, IREx added a PDF of the site-specific SSRP to the Local Considerations export. Now, the SSRP PDF is available for download from the Status Summary tab when you click on the Reliance Decision for a site. This is an additional way to review details of a site’s SSRP for a study. The name of the file includes the participating site’s name.

Updated Feature: Single Entry of Team Personnel Added by Study Manager

Edit Participating Sites, FRL, Getting Started Checklists, IREx Study Manager, January 2020, Relying HRPP

The site contacts (e.g., PI or Coordinator) listed by the Study Manager will auto-fill as members of the study team when the Participating Site HRPP registers for a study. This allows the HRPP Liaison to confirm existing contacts, rather than having to re-enter the contact information. After the HRPP liaison has registered and confirmed the contacts, they receive access to IREx and the study. After a site has registered, the PI and Coordinator information is locked to the Study Managers, so the site edits personnel if needed.

Updated Feature: PI Checklist Now Includes Study Team Step

FRL, Getting Started Checklists, January 2020, Study PI

When a PI logs into IREx, they see their Getting Started Checklist on the left-hand side of the screen. A new first step has been added: Add/Edit Study Team. Any study team members added by the Study Manager or Reviewing IRB are listed in the dialog. The PI can confirm these members and/or add additional PIs and Coordinators in this step. Team members entered by the Study Manager or the Reviewing IRB will not have access to the study on IREx until the PI confirms this dialog. This new step facilitates participating study teams’ access to IREx.

New Feature: Email Notifications for Updated Approvals

Approvals, Coordinator, December 2019, Edit Participating Sites, Email Notifications, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, Study PI

A new email notification is now sent when any existing approval – for the overall study or a participating site – is updated. For example, if additional documents are uploaded or exchanged, an email will notify the relying site’s HRPP and study team personnel of the revisions and the exact changes are detailed in a table. The notification will bring clarity to the email notifications and ensure sites are aware of updates or changes to their approval, as specified in section 5.9 of the SMART IRB Agreement, “Notification of IRB Decisions, Changes, Lapses in Approval.”

New Feature: SSRP Included in Local Considerations Export

Agreements/ Reliance, December 2019, FRL, IREx Study Manager, Study-specific Reliance Plan (SSRP)

A PDF of each site’s Study-specific Reliance Plan (SSRP) is attached to the Notification of Reliance email sent when the SSRP is accepted by a site; however, sIRBs were previously unable to download site-specific SSRPs from within IREx. Now, the Local Considerations (LC) export will include a PDF of each site’s SSRP. The LC export will continue to include each site’s Institutional Profile, HRP survey and PI survey, if LC are being captured in IREx, as well as any documents uploaded to those surveys.

Updated Feature: Getting Started Checklist Revamped

Coordinator, Frequently Asked Questions, FRL, Getting Started Checklists, November 2019, Relying HRPP, Status Summary Tab, Study PI

Some steps of the HRPP Getting Started Checklist can be edited after you have completed them. To make this clearer, we added a pencil icon to those steps. HRPPs will see a pencil next to Add/Edit Study Team, Confirm Institutional Profile, Complete HRP Survey, and Validate PI Survey. We also added a “See Status Summary” link on the participating site HRPP and study team Getting Started checklists to provide quick access to the Status Summary tab, which is now available to all participating sites on a study.