Category Archives: Email Notifications

New Feature: sIRB Can Close Studies on IREx

Approvals, August 2021, Coordinator, Dashboard, Email Notifications, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, Status Summary Tab, Study PI

sIRBs can now close studies that are complete on IREx by uploading the reason and date of closure, as well as the IRB determination letter. Closing a study notifies sites that the study has ended. The study remains accessible to all registered sites after a closure is posted, and all past approvals become read-only. A record of sites’ reliance details and a history of sIRB site approvals are still available in all IRB exports for metrics. For instructions on how to close a study, see our Quick Guide.

Here is what you will see for a closed study:

  • Study page is grayed out with a Study Closed header at the top
  • Status Summary Tab shows as Closed in Approval column
  • IRB Dashboards show that a study has been closed
  • Versions box shows that a study has been closed
  • Exports show closed studies with date of closure

Updated Feature: Email notification includes helpful guidance when new sites added

Edit Participating Sites, Email Notifications, FRL, IREx Study Manager, June 2021, Relying HRPP, Reviewing IRB

When a site that has not joined IREx is listed on a study, the “Participating Sites Added to Study” email now includes helpful text to guide how the site HRPP/IRB can initiate access for their site through the Join IREx page. This is an existing email sent to Reviewing IRBs and SMs if either party adds new sites to a study, but now updated for clearer guidance.

New Feature: Relying Site HRPPs receive email when their site can indicate reliance.

Agreements/ Reliance, Email Notifications, FRL, March 2021, Relying HRPP

If a Relying HRPP registers for a study but has incomplete reliance or indemnification agreements, the Relying HRPP can confirm their local study team and complete local considerations. However, they cannot indicate reliance until all reliance and/or indemnification agreements are executed. Now, IREx will send an email notification to the Relying HRPP when the sIRB indicates all the required agreements have been executed. This email lets the Relying HRPP know they can indicate reliance.

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.

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.”

Updated Feature: Protocol Version

Approvals, Email Notifications, FRL, IREx Study Setup, November 2019, Reviewing IRB

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: Tracking Changes to the Local Considerations HRP Survey

Coordinator, Email Notifications, FRL, IREx Study Manager, Local Considerations, October 2019, Relying HRPP, Study PI

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.